Posts in category: Patient Recruitment

I recently outlined some strategies you should consider for speedy recruitment of patients into clinical trials (https://www.rossjackson.co.uk/3-strategies-for-speedy-enrollment-of-patients-into-clinical-trials/) and now I’m highlighting some approaches you can take for recruiting patients over a longer time frame.

Why Recruit Patients over a Long Period?

At its simplest, you may have, for example, a 2-year period from the launch of your recruitment campaign to the time of ‘last patient in’ – giving you a reasonably long time frame to implement your enrollment strategies.

Another consideration may be if you anticipate conducting multiple trials for the same condition or therapy area over a long period. For instance, if you specialize in a particular type of treatment. Your recruitment activities here may be based on identifying people who wish to participate, then getting in touch with them when a suitable trial is available.

Database of Potential Participants

Building up your own database of potential trial participants is an approach that can be very successful in the long-term. This is particularly useful if you know you will be working in the same therapy area for the foreseeable future, with multiple trials in your predicted pipeline. While you may not currently have anything available, you can attract applications from people who are expressing their interest. Thus you have a readymade database of potential patients who you can assess for the future trial’s criteria.

Database building can also be effective for enrolling participants in trials when they may not be suitable for an initial one they apply for. This can be especially valuable for organisations that specialize in developing multiple treatments for a particular condition – as people who didn’t fit the Inclusion/Exclusion criteria for one trial may qualify for a future study.

Digital Ads for Long-term Patient Recruitment

With my background in digital marketing, this may make some people think ‘to a man with a hammer, everything looks like a nail’. But I make no apologies for continuing to promote the use of digital advertising when it comes to patient recruitment, as I’ve yet to come across any other method that delivers large numbers of patients for trials as successfully.

Certainly, other methods also work, but for the biggest ‘bang per buck’, digital ads remain the number one most effective means of attracting trial participants. Both in the short and the long term.

The digital ads platforms all have their own regulations that you’ll have to conform to – with Facebook in particular being very strict with the type of content it allows to feature, and platforms such as Twitter not allowing clinical trials advertising throughout most of the world.

Tip: Ads that are not based on a specific trial need not pass IRB/EC approval – enabling you to build up your database of potential participants over a longer period and ongoing. For instance, your ad can suggest that you’re looking for people to indicate their interest in taking part once a trial becomes available. Then you can follow-up with them once you have a suitable trial and IRB approval for your patient-facing communications.

Tip: Once you have a sufficiently large database of potential trial participants, in platforms such as Facebook you can use this to build Lookalike audiences – ie Facebook will use the Lookalike audience settings to show your ads to people whose online behaviour is similar to that of the people in your database. The idea being this will help you to target people who are more likely to want to participate in your trial.

Tip: Facebook and other platforms consistently steer advertisers towards video ads as being the most effective method of communicating a message. However, in my experience it’s still ads based on having a single image that attracts the most interest – the type you’ll be familiar with from the standard Facebook feed.

Informational Website

One of the best long-term methods for building interest in a trial is to develop and promote an informational website featuring content about the condition and the trial itself. I’m still surprised by how many trials launch without their own website – effectively cutting off a large proportion of people who might be encouraged to apply to take part.

Including a method of applying for a trial, or registering interest in possible future trials, is a very effective means of you building your own database of potential trial participants. Incorporating pre-screening questions in the application form – linked to a suitable backend patient platform – will enable you to identify people who are suitable for specific trials, based on the relevant I/E criteria.

As well as details for specific trials, of course, you can simply develop an informational website that is condition-specific and talks about trial participation in general. This can help to build interest for when you launch a trial in the future, plus give you more credibility among the patient population through providing useful information.

Tip: Informational websites can be useful from an SEO perspective (Search Engine Optimization). Providing useful data and information that may not be available elsewhere – for example, any relevant trial data you may have collected in similar trials – can help your website rank higher in search engines for relevant searches.

Tip: Creating content based on the testimony of existing/previous trial participants can prove very effective for building a rapport with the patient population. Obviously, you have to be mindful of regulatory issues regarding anonymity, but you may be able to create content based on a previous trial that can help inform potential participants of what to expect.

Community Engagement

Having an ongoing dialogue with people who could participate is an underused technique for generating interest in your trials. Through means of communication, you can build trust in the idea of joining a trial, as well as helping cement the concept in people’s minds as being one they should consider.

Patient communities are an obvious place to look at here – with each condition likely having multiple groups where patients and caregivers can share information. Be aware, though, that patient groups can be distrusting of organizations who appear only to be interested in them when they want something from them – ie when looking to recruit trial participants. In particular, it’s usually proven particularly difficult to gain any traction with the many patient-related Facebook Groups that exist, as these are generally closely-guarded environments designed for people to discuss their condition with like-minded others.

You should also bear in mind that patient groups (including such organizations as Patient Advocacy Groups) are only representative of those people who have actually joined the group. There will be other potential trial participants who are not interested in being part of a group, so you shouldn’t assume you are reaching the entire possible audience if you do start communicating with a patient group.

Outside of patient groups, of course, there is the opportunity to build interest within other types of community – such as people in a particular location. This can be especially effective if you know you are likely to have a participating site in the locale, and wish to generate some interest prior to the launch of the trial.

Diversity and Inclusion have very much become more prominent in people’s thinking when it comes to attracting patients for trial, so developing a relationship with a particular community in an ongoing manner – ie not just when you’re recruiting for a specific trial – can be a great way to build trust and have your message resonate more effectively.

Tip: Patient-based information, such as that developed for the Informational Website suggested above, can be used for approaching patient groups and encouraging them to share it with their members. For example, video testimony regarding trial participation, or an outline of someone’s experience living with a particular condition.

Tip: Local communities often have focal points that can be utilized for presenting your message and becoming more widely-known. For example, churches, community centres, local markets, shopping malls, charity events etc.

Press and Traditional Media

When I was first involved with patient recruitment, the standard advertising methods for central recruitment campaigns were radio and newspaper ads. Indeed, these approaches are still widely-used today – though have been somewhat superseded by ads on digital platforms such as Facebook and Google.

Traditional promotional methods still have their place, though – especially when it comes to supporting other activities for building awareness of a trial in the long-term. (The idea being that if someone sees the trial featured in a newspaper, then hears about it on the radio, then sees it again on social media, the message will sink in more strongly).

As well as the obvious advertising opportunities, it’s also worth investigating how to make use of PR to generate interest in your trials. Editorial articles within a magazine or newspaper can help to raise awareness that a trial exists. Similarly, an appearance on radio or TV shows (or podcasts) as an expert guest can help build credibility.

Tip: Try to identify something newsworthy about your trial that you can incorporate in your PR efforts. For example, a local celebrity, or someone with influence in a particular community, may be interested in helping promote your trial.

Tip: If you are able to identify a high prevalence for the condition in a particular demographic, you may be able to target them through a publication or broadcast show aimed at those people. (e.g. local newspaper, special interest magazine or podcast).

Conclusion

Recruiting patients for clinical trials in the long-term is not just beneficial for the trial in question, it helps promote the idea of trial participation in general.

This kind of snowball effect of having more people interested in taking part in trials can only be a good thing for the industry as a whole, and for helping with enrolment into your future trials.

If you need to recruit patients for a clinical trial in a speedy manner – for example, if your trial is ‘in rescue’ or you have a limited recruitment window – here’s an overview of the 3 most effective strategies and techniques you should consider.

1) Quickest and Most Effective – Direct to Patient Digital Ads

Having been described as ‘the godfather of social media patient recruitment’, it’s probably no surprise that I suggest digital ads are the most effective method for speedy recruitment. But my recommendation is not simply because I have a lot of experience with digital marketing – it’s the fact that digital marketing consistently works extremely well. (My fundamental aim is to get patients on trials effectively and efficiently, so if I ever come across something else that works better, I’ll be recommending that instead.)

Search Ads

Digital ads are most effective when they appeal to a desire that people already have. One way that digital ads can capitalize on this is to use search ads (eg Google Ads) which will be shown to someone who searches for relevant keywords. Now, the number of people searching to try and find a clinical trial they could participate in is quite low (though increasing), so you’ll not want to limit yourself only to search phrases that include the words ‘clinical trial’ or ‘clinical study’.

And it’s likely that many of the people using search words for specific conditions are going to be either living with the condition, a carer, or a Health Care Professional (HCP). Which means that showing your ads to those people could encourage them to click through to learn more about the clinical trial you’re running, as it may be relevant to their circumstances.

Online Application

As to what happens to the person once they click through from the ad, I’m still surprised by the number of clinical trials that launch without their own website. Or, if they do have a website, there is no method of applying for the trial directly from it. (Many sponsors and CROs relying on the possibility of potential participants contacting a study site directly or navigating their way through the ClinicalTrials.gov website in order to apply). This is a big mistake.

Enabling people to apply for a clinical trial online is one of the easiest ways to capitalize on the interest the person has already shown – by clicking on the ad – and take them through to the next stage of the qualification process.

Quite simply – if you’re not providing potential trial participants with a means to apply direct from their computer of smartphone, you’re significantly limiting your chances of recruiting sufficient patients for your trial.

Social Media Ads

Whatever you might think about social media, it’s somewhere that people spend a lot of their time. (GlobalWebIndex reporting that in July 2022 there were over 4.6 billion active users of social media worldwide, with an average daily use per person of 2.5 hours).

Facebook is still the most widely used platform, and in my experience represents 60%+ of the patients recruited through digital ads. One of the great aspects of Facebook that has made it so successful is the ability to share ads with other people. Which means that, for example, if I am not living with a particular condition myself, but I know someone who is, I can share the ad with them – thus increasing the reach of the ad and having it be seen by a wider audience.

One feature of social media ads targeting – that is common to all platforms, not just Facebook – is the ability to show your ads to people based on their location and demographic information (such as age and sex). This enables you to only show your ads to people who fit within the I/E criteria for your trial protocol, as well as aiming for people who live within a certain distance from your selected study sites.

Tip: When setting up search ads, Google isn’t the only game in town. People who use Bing are likely using it because they prefer it to Google, or they’re simply using it as it’s the default search engine included with Windows. Either way, you can potentially reach an audience on Bing that you wouldn’t be able to reach on Google.

Tip: While Facebook is still the biggest single platform for recruiting patients, there are several other platforms that are worth investigating – including, perhaps unexpectedly, TikTok. (Which I have seen perform well even when targeting a much older demographic than the teenage or Gen Z population you might expect to be using it).

Tip: To speed up the process even further, you can set up a relevant ad campaign that is not trial specific – thus circumventing the need for IRB/EC approval prior to the ads going live and enabling you to generate interest sooner. People who respond to these initial ads can then be put into the IRB/EC approved process for enrolling them in the study.

2) Social Listening to Identify (and Reach Out to) Influencers and Key Opinion Leaders

One thing we all know about the internet is that it attracts a lot of people who want to voice their opinions. Mention of Twitter often conjures up images of people ranting about their own pet subjects, or heated online arguments where nobody listens to a different point of view. However, on many online platforms (including Twitter), you can also find people who are talking rationally and providing useful information to a receptive audience.

The act of ‘social listening’ is about finding the people who are talking about relevant topics on social media platforms and online forums – in our case, conditions or therapy areas. Then identifying those who have sufficient influence to be able to promote our trial in order to recruit patients for it. (ie those who have a group of followers who engage with and listen to them).

These Key Opinion Leaders (KOLs) may be doctors or medical professionals, or they may be patients or carers who have built up a reputation for providing useful information about a specific condition. Reaching out to them to have them promote your trial gives you access to an audience of relevant patients who are likely to accept the KOL’s recommendation more readily than if they are approached by someone they don’t already have a relationship with.

Tip: Having someone from your clinical team reach out to the KOL – maybe Chief Medical Officer or similar – will be more likely to generate interest from them for initiating a dialog.

Tip: Don’t just look at the main social media and online platforms. A site like Quora – where people ask and answer questions – can help identify people with a relevant following.

Tip: Social listening is also very useful for identifying the language that relevant patients are using to describe their experiences. Emulating this language in your messaging can help it to resonate with the people you want to attract into your trial.

3) Patient Databases

In theory, databases of patients living with a particular condition should be a valuable source of potential trialists. In reality, the various Patient Advocacy Groups that exist guard their data closely and are not always willing to share access to it. (Plus, obviously, there are privacy and data protection issues they will need to consider).

If you’re developing a treatment for a rare disease, you may find the relevant Patient Groups are more amenable to your approach. Whether your treatment is for a rare disease or a more common condition, though, you should be prepared to explain to the Group the benefits of their contacts taking part in your trial. And ultimately there is likely to be a fee involved for gaining access to their database. Whether that is a one-off fee for them to send out a mailshot or advertise your trial on their website, or a pay per patient fee based on their helping you reach patients who go through to randomization.

Patient Groups often receive many requests from sponsors, CROs, and patient recruitment firms for promoting trials to their database. You should ensure you stand out from the other requests by being clear about the specifics of the trial and why patients should consider participating. You should also always be transparent and timely in your interactions and signal your willingness to build a long-term relationship with the Group. (If you only appear interested in patients in order to further your own short-term ends you are unlikely to gain much traction from this kind of outreach).

Tip: Local organisations may have access to patients that national ones don’t. If you have a study site in a particular city, it may be worth searching for a smaller charity or patient group that is based in that area, as these organisations may be more willing to help promote your trial.

Tip: Engaging with individual patient advocates who are active within specific Patient Groups can help smooth the path for being able to promote your trial to the Group’s database of contacts.

Tip: As with the KOL strategy, it may come across as more credible and be more likely to initiate a dialog if your CMO or someone else from your clinical team reaches out to the Patient Group.

Conclusion

For speedy enrollment of patients into your trial, at the very least you should ensure you have a means for people to apply directly online. Combining this with digital ads is the quickest and most effective method of reaching a group of relevant people. Adding in social listening and/or outreach through patient databases gives you a proven set of actions you can take to recruit patients quickly.

And it’s always worth remembering that the quicker you recruit patients into your trial, the sooner you may be able to bring your treatment to market. Thus saving expenditure, increasing overall revenues, and – most importantly – helping more patients.

Putting patients first and incorporating patient-centricity in the design of trials has become the mantra of the industry. But what do these things mean in terms of how you go about designing and managing a trial? Here’s an overview of some of the things you should consider in order to recruit and retain more participants through having your trials be properly patient-centric. (And, indeed, viewing patients as people can be a fundamental part of this process, turning the phrase ‘patient-centric’ into ‘person-centric’. I’ll stick with the conventional term for this article, though, as it is in common use).

CISCRP Perceptions and Insights Study

Every couple of years, the Center for Information and Study on Clinical Research Participation (CISCRP) carries out its Perceptions and Insights Study, surveying public and patient views on clinical research around the world – https://www.ciscrp.org/services/research-services/perceptions-and-insights-study/. I’ve incorporated a few of the findings from the most recent one, in 2021, in the recommendations below.

Patient Engagement

One of the main industry buzzwords of recent times, patient engagement is about so much more than conducting surveys or focus groups. Having the patient voice incorporated in the design and management of clinical trials throughout the process is an oft-overlooked method of ensuring they are patient-centric. Obviously, there is going to be a balance between what patients would ideally want and what might be possible to include in the protocol. But having patients involved from the outset will help to build a process that is as close to the ideal as possible.

Pre-Recruitment Activity

Even before a study is live, there are certain things you can do to build up a database of potentially interested people via such means as digital advertising regarding a particular condition. From a patient-centricity angle, pre-recruitment activity should focus more on education and rapport building with relevant communities. Nothing smacks of ‘big pharma’ more than only being interested in a patient population when recruiting for a trial, and paying no attention to them before or after.

This is another area where true patient engagement will help generate interest in the trial, plus build more trust and credibility for the world of pharma as a whole. (Which, as well as being a good thing in general, should be useful for the next time a patient recruitment campaign is being conducted). Having people ‘on the ground’ to support any digital or printed resources that have been developed can help to raise awareness of the value in trial participation and generate an audience that is more receptive once the recruitment phase begins.

Reducing the Burden of Participation

One of the main aims of patient-centric design is to reduce the burden on the participant, such that taking part is an easy process that doesn’t impact on their life more than is necessary. To achieve this, we should start at the trial design stage, to ensure the protocol is an attractive one for people to adhere to.

It’s a common issue raised by research site owners that some protocols place such an onerous burden on participants re: multiple site visits, that they sometimes wonder why anyone would sign up to participate at all. Clearly there are many factors involved here – with the necessity for specific testing that can only be carried out at a site being one that is difficult to get around.

One area that can be looked at for helping reduce patient burden is the number and type of endpoints that are being measured in the trial. It would be nice to generate as much data as possible from each interaction with a trial participant. But if that leads to an unwillingness to continue on the trial due to the excessive burden, the data is ultimately of no use anyway. Far better, more likely, to focus on the key endpoints to help retain more people on the trial for longer.

Making Site Visits Easier

The advent of the Covid pandemic saw a huge amount of interest in Decentralized Trials (DCTs) – where all or some of the treatment and measurement that is normally provided in a research site setting is carried out elsewhere, such as in the patient’s home, a local pharmacy or surgery. The focus has primarily been on providing DCT tech solutions to deliver the desired results. However, since we started getting ‘back to normal’, the industry has realised that the tech has to actually be useful, rather than simply innovative, and has to be able to be combined with the human approach that the sites have been offering all along. Which has led to a situation where trials are still conducted primarily through site visits, but with additional options available as well.

Interestingly, the CISCRP study highlights that there is little difference between people’s willingness to participate in a trial that is purely conducted through site visits, through nurse visits to the patient’s home, through some site visits and some home visits, or through having all the data recorded through the use of tech in the home. What this indicates, of course, is not that it doesn’t matter which option you pursue – more that it helps to provide a range of options that people can choose from for themselves.

Whether you are managing a trial that consists solely of site visits, or one where there is a mix of site and home visits, to be patient-centric you should invest in a means of getting patients to the site that makes it easy for them to do so. Transportation and accommodation being provided to trial participants – and arranged by you without the participant having to expend much mental energy or any of their own funds – will help in this regard.

Providing the Treatment to all Participants

One successful method of increasing recruitment into a randomized trial is to inform all participants that they will eventually be able to take the treatment – if appropriate in terms of its efficacy – even if they are in the placebo arm of the study. This is also a great means of retaining people on the trial once they’ve consented to participate.

The CISCRP study had ‘Feeling/seeing benefit from the study drug’ as the top-ranked statement expressed by their respondents for ‘items that would be most likely to keep you enrolled in a clinical research study’ – supporting the idea that people are keen to take the active treatment, so should be allowed to do so at an appropriate time.

Another factor to consider here for recruitment purposes is the possibility of having a higher ratio of active treatments to placebo in the randomization split. If a participant believes they have more chance of receiving the active treatment (eg through a 2:1 split of active:placebo, rather than 1:1), it will likely be more attractive for them to take part in the trial.

Incentives for Participation

Clearly this is dependent on the regulations in the area you operate in, but fundamentally we should always keep in mind that patients are giving their time and access to their physiologies to take part in trials. At the very least, expenses should be covered – and, as I say above, travel and accommodation should be dealt with on their behalf and not as an out-of-pocket expense they get reimbursed for – with, ideally, a separate payment being made for the time input involved.

Outside of monetary compensation, providing the ongoing health monitoring that goes with trial participation is another incentive that can attract people both to take part in the first place, and to remain on the trial once it’s underway. Having regular check-ups of various health indicators is something that most people will not experience in their everyday life, and is almost certainly going to be viewed as a benefit of being on a trial.

Keeping Participants informed

The CISCRP study indicated that the second most important factor that would help retain patients on a trial was ‘Being informed of the clinical research progress on a regular basis’. This is not surprising, when you consider what participants are being asked to do during the trial, so it’s simply common sense that they would wish to be updated. However, it is still not universally the norm for there to be a good level of communication between the study organisers and participants – an easy fix that can be implemented to help with retention.

The CISCRP study went on to indicate that the primary means of communication people were interested in for study updates is having a summary emailed to them. Other options – such as a printed summary being mailed, results being available through an online portal, a teleconference or webinar detailing results – were also methods of communication people expressed a preference for. Again indicating that offering choices is the most patient-centric approach.

The Personal Touch

Having personable people as the main point of contact for trial participants is a simple approach that can help build rapport and keep people motivated in participation. On top of this, additional touches such as sending birthday cards and remembering important details about individuals (favourite sport, where they went on holiday etc) can help reinforce the sense that they are a valued member of the team.

Conclusion

Ultimately, being patient-centric is about being person-centric – treating the people on the trial as we would wish to be treated ourselves. If we look into this a little more, we can see that a key factor is the availability of choice. Offering participants a choice of how they participate – in clinic, fully remote, a hybrid of the two – plus assisting with whatever means are necessary to facilitate these choices, as well as offering different methods of communication etc, will help make the process of patient recruitment and retention more effective and efficient for all concerned.

February’s SCOPE Summit was a well-attended event, both in person and online, delivering lots of valuable and informative content for improving the effectiveness of various aspects of clinical operations.

As well as the sessions, there were many exhibitors and sponsors representing the types of solutions that can help manage trials more effectively. Within my own specialism there is a wide – and actually somewhat bewildering – variety of services on offer.

Having spent a lot of time identifying and validating the effectiveness of different approaches, here’s an overview of some of the different types of solutions that are available to aid with patient recruitment and retention.

Types of Solution

The various solutions on offer fall broadly into four categories of service – consultancy/advisory, digital/technology, communications/outreach, concierge/assistance – with plenty of overlap between them in certain areas.

I’m going to look at the types of solutions available throughout the patient’s journey from being unaware of a trial to participation and (hopefully) trial completion.

Solutions Throughout the Patient Journey

When looking to recruit and retain patients, the four steps on this journey can be identified as:

Find – identifying potential trial participants.

Engage – presenting them with information about the trial in order to generate interest.

Qualify – ensuring they meet the Inclusion/Exclusion (I/E) criteria and are happy to consent.

Retain – keeping them interested and engaged with the trial ongoing.

Step One – Find

A lot of the solutions on offer focus on finding patients who might be willing to take part in a clinical trial. Traditionally, one of the most common methods for doing this would be to approach research sites in a feasibility process to determine if they may have sufficient numbers of patients ‘on their books’ who would fit the criteria for participation.

There are several solutions available today for helping with this process, such as consultancy and digital services that can help identify geographical regions and research sites within those regions that already have a relevant population pool in a nearby radius.

Having this data available in a digital format, such that it can be sorted into appropriate outputs quickly and efficiently, provides the opportunity for a much smoother site selection process than was previously available. Various vendors exist that can provide this type of information, as well as multiple CROs and sponsor organisations having their own databases to utilize.

Another area where digital solutions can help is the identification of patients from a site’s existing records. It can take many hours of someone’s time in manually searching through to match patients against a trial’s I/E criteria, but there are now systems available that can do the bulk of the searching for you.

The idea of targeting people through digital advertising is a well-known one in the field, and there are many companies and individuals who can assist with finding the right platforms to advertise on. One thing that can often be forgotten, though, is the amount of ‘click fraud’ that can take place on the popular advertising platforms. Utilizing a click fraud prevention service can not only save thousands of dollars in ad spend, it also helps deliver better results through having your ads being seen by actual people, rather than suffering from wasted clicks by bots.

Of course, not all the available solutions for reaching patients directly are digital in nature. Traditional forms of advertising – such as national or local newspapers, radio and TV – can still prove effective for particular audiences, with several agencies and service providers able to help in this regard.

Adopting a grassroots ‘on the ground’ approach to providing information to particular communities is another activity that can be effective. Obviously, this approach is one for the long-term, but it can certainly pay dividends – especially for engaging with people from underrepresented populations.

Tied-in with this idea is that of building relationships with particular patient groups. I’m aware of several solutions providers who can assist with both of these approaches – including services to help identify relevant groups in the first place in order to contact them.

It’s also worth bearing in mind when reaching out to Patient Advocacy Groups (PAGs) that there will also be a large number of patients who are not involved with the PAGs and don’t qualify as Key Opinion Leaders (KOLs). Services exist that can help you identify and reach out to these ‘hidden patients’, so that you’re getting feedback and information from as wide an audience as possible

One of the biggest talking points in patient recruitment is the small number of referrals that come from Health Care Professionals (HCPs). Identifying and engaging with relevant HCPs – i.e. those who should be able to make referrals to the trial based on their own patients – can help with this, by making physicians aware of a trial taking place that may be suitable for patients in their care.

There are several solutions you can adopt to achieve this. These include systems to help with ‘social listening’ – which enables you to identify the HCPs (and patient advocates and KOLs) who are most actively discussing relevant topics online. Also, there are methods of identifying HCPs who have sent patients for relevant lab tests. Plus, it is also possible – in the United States, at least – to access some medical claims and Electronic Health Records data, thus providing another method of identifying relevant HCPs you can contact.

There are also multiple patient registries and databases of patient records that can be accessed through various solutions providers for finding patients who fit the I/E criteria for your trial.

Step Two – Engage

Once you’ve identified a pool of potential trial participants, you then have to engage with them to give them the information they need for deciding to apply. Obviously, good communications will come into play here. Plus, you need to ensure your messaging sticks within the regulations and guidance for the territory you’re operating in, with Institutional Review Board (IRB) or Ethics Committee (EC) approval for anything trial related.

In the case of digital and traditional methods of advertising, this engagement initially takes the form of the advert content. IRB and EC rules state you can’t be ‘coercive’ or make unverifiable claims, and each platform or media type will have its own rules you have to abide by. Which is why there are many agencies and specialists who it makes sense to utilize for setting up and managing your ad campaigns – many of whom I’m familiar with and can vouch for in terms of their suitability and effectiveness.

As well as engaging directly with potential patients, you can engage with HCPs. Having identified the ones who are most likely to have relevant patients, you can utilize methods for contacting them – using their preferred method, such as email, social media ads, phone call etc. – to present your information and engage them in a dialogue about referring their patients for the trial.

The same approach can be adopted with KOLs for the relevant condition your trial is based on. These KOLs may be patients or representatives of PAGs, or they may also be HCPs, carers, relatives, or friends of people living with conditions. Services exist which can help you identify and communicate with HCPs, KOLs, and PAGs, in order to get the word out about your trial and encourage them to promote it to relevant people in their network.

When engaging with any of your target audience, it’s essential you get your message across in the right way. Which is where various communications agencies and specialists can assist to ensure you have the right balance of information and persuasiveness, while not contravening IRB or EC guidelines.

Step Three – Qualify

For applicants to be accepted to participate in trials, they need to match the relevant I/E criteria for the trial in question. Much has been made in recent discussions online about how sponsors often simply ‘copy and paste’ criteria from previous trials of a similar nature – which can lead to criteria that are needlessly restrictive. This has the effect of limiting the pool of potential participants to a smaller number than would be able to take part if the criteria were less restrictive.

Engaging with patients, patient groups, site representatives, and patient recruitment consultants to help you with the original trial design and protocol development can help iron out some of these issues. They can help you with determining whether specific criteria and reporting activities are necessary for the trial – thus potentially opening up participation to a wider audience.

As part of the application process, you can qualify potential participants – using an online web form – by asking questions about their condition and background. This then delivers pre-qualified applicants into the full trial screening process. Thus saving time and resource through having filtered out non-relevant applicants at an early stage. Many service providers can assist with setting up a suitable website for this purpose – or at the minimum, creating relevant pages that can be hosted on another site, such as a clinical trials hub.

Beyond this, the backend of the application platform can provide sophisticated analytical capabilities for further identifying and keeping in touch with potential participants. Another advantage of these types of platforms is the transparency of reporting that is available. For example, identifying how well each region and/or research site is performing in order to improve results. (As well as the technical provision of the platform, there are also consultancy services you can make use of to help each site or region adopt the best practices of the ones that are delivering the best results).

One of the key factors in converting people who express an interest into people who go through to participate in a trial is having a speedy follow-up process in place. There are multiple solutions that provide an instantaneous digital communication method – e.g. sending a text to their phone, email responses, messages on an app. But what has proven consistently to be the most effective is a follow-up phone call within twenty – thirty minutes of the person submitting their application form. (Obviously subject to trial qualification – see below). To help with this, you can make use of a relevant call centre or nurse panel who provide this ongoing communication service.

Step Four – Retain

It’s well-known that patient recruitment is a major problem, but almost as much of an issue is that of retaining patients in the trial throughout its lifespan. Each time a patient drops out of a trial, it reduces the amount of data available, plus may require additional resources and effort to recruit another patient to replace them.

Much has been made of the possibilities for ‘gamification’ of apps on digital devices to keep people engaged with the process of a clinical trial. There are multiple solutions available in this regard that allow for patient reporting of data, to provide ongoing updates, and to find out relevant information throughout the trial. And certainly, some people will be happy with this approach.

However, it’s best to provide a range of options for how patients can interact with the mechanics of the trial – including regular communication with people who can provide guidance and ongoing encouragement. A range of services are available that provide this ‘digital plus human’ approach to keeping trial participants engaged.

Ongoing communications is a key factor. Again, you should provide a range of options for how to keep in touch with patients on trial, allowing them to choose their preferred method – e.g. text, email, within an app, by phone call. As well as obvious communication events – appointment reminders and the like – you can incorporate some nice additional touches such as birthday cards and ‘thanks for participating’ cards. There are organisations that will set up and carry out this ongoing communication service for you.

One of the things that will help keep participants engaged with your trials is the sharing of information about what’s happening. And not simply a clinical overview that a non-specialist wouldn’t be able to understand. Translating medical information into layperson’s language is becoming increasingly mandatory in the field of clinical trials. Which has led to there being many agencies and writers available who can put together engaging and informative information to help retain patients on trials.

Trial design consultancy – especially when you have patients involved in the process – can help ensure the burden of participation is not too onerous. This can include incorporating decentralized elements such as in-home or local visits – decentralized trials being a topic that has become much more than simply a buzz phrase in the last few years, with an enormous range of effective potential solutions available.

Other factors may include allowing patients in the placebo arm to take up the treatment if it proves successful. (And obviously anything that can be seen to be reducing the patient burden for participation is beneficial for encouraging people to apply for the trial in the first place).

Another aspect that can put people off or become a factor for them dropping out of a trial is the expense and hassle involved in having to travel to a research site for appointments. You can make use of a concierge style service to manage people’s travel and accommodation for them, which can help ease the burden and improve retention.

Conclusion

Given the range of types of service on offer for helping with your patient recruitment and retention challenges, it’s no surprise that people managing clinical trials can sometimes get lost among the number of choices available.

I spend a good deal of my time identifying and validating these various services – in essence, so that you don’t have to – which means I can help select the right solutions for your specific requirements. With my experience in the field, I can also help you manage the ongoing relationships with these solutions providers for optimal results – thus freeing up your time to focus on delivering the best possible outcomes for your trials.

Get in touch if you want me to point you in the right direction for the best solutions for your circumstances.

Following on from my recent article about effective strategies that can be used this year (2022), I’ve peered into my crystal ball to see what the landscape might look like for patient recruitment and retention ten years from now – based on the same categories identified in that original article and written as though we were already in the year 2032.

For many of these options to be available there would obviously need to be significant developments over that time, particularly in such areas as data sharing and regulatory approvals, compared to where we are now. But we certainly seem to be heading towards a situation where each of these approaches is possible:

HCP Outreach

Offering a clinical trial to patients has become standard practice for HCPs over the last few years, but they still need to be made aware of the trial and how it relates to their patients. Universal sharing of medical records has made it easier to identify patients who are likely to fit the inclusion/exclusion criteria, so you should be utilising this capability to present your trial to a doctor when they are researching suitable treatments during a patient meeting.

All the major HCP admin systems now allow for this kind of identification and associated messaging, so you should ensure you provide all the relevant details in a digestible, bitesize format for the doctor to present to their patient – bearing in mind they will only have limited time to do this. One of the best options here is to have the doctor present the patient with a scannable code that allows the patient to access all the relevant information on their smart device.

This provides the capability for the patient to apply for the trial there and then if they have time –through spending a few minutes in the waiting area post-appointment – or to set a reminder to popup on their smart device at a more convenient time. Ensuring there is engaging and informative content available in the trial apps that the patients access will help aid the recruitment process.

There are also many HCP surgeries that have dedicated clinical trials sign up systems in an area set aside for this purpose. Allowing patients to access all the relevant information they need, as well as choose from a range of available trials they can apply for, with a clinical trials specialist nurse on hand to assist if they want help from a real live person.

Pharmacies, too, can play a role here. Both through having general messaging on display about specific trials, and through having a trigger message attached to the provision of specific treatments that are likely to indicate a patient living with a relevant condition. (Adhering to all the privacy regulations, of course, such that only the intended recipient is made aware of the trial).

Digital Outreach – Direct to Patients

Plenty of opportunities here to reach patients ‘where they are’. Streaming TV provides a great platform for highly focused targeting of people who match the demographic profile for your trial’s inclusion/exclusion criteria. The ability to input a list of contacts who have opted-in to receiving communications about relevant trials based on their health records – and also build a ‘Lookalike audience’ based on these people – helps to further narrow the advertising capabilities to target the people most likely to act on your messaging.

But make sure you check the option to ‘only show ads to specific people, not when others are watching alongside’ – as identified by people’s home smart sensors – to avoid any possible privacy issues from showing ads based on personal health information to people other than the relevant person. (And obviously many people watch streaming TV on their own devices anyway, rather than the main family TV).

The existence of digital ‘trial marketplaces’ has helped to both raise awareness of the existence of trials, and to ensure that trials are developed in a more patient-friendly fashion. Being able to pick and choose from a range of trials based on a patient’s own criteria for what they’ll be prepared to go along with, has somewhat shifted the balance of power in favour of the patient/consumer and away from the sponsor being able to dictate the terms of engagement. Making your offer look more appealing to potential trial participants is a key factor in attracting applications through these trial marketplaces – much of which will be based on making the trial as easy to participate in as possible, plus answering the patient’s main question of ‘what’s in it for me?’.

You may also be successful in setting up your own Virtual Reality trial outlet in the multiple versions of the metaverse and virtual social media platforms that people are known to participate in. The settings for these platforms allow for your outlet to appear only to your relevant target audience, and only when they are likely to be amenable to receiving your message – whether passed on via a ‘real person’ avatar or simply in the form of some kind of advert or poster in the location they are visiting. Analysing the data ongoing for which options work best here will help refine the recruitment process, so you can attract a large number of suitable applicants.

Of course, it’s not all about digital when it comes to patient outreach. While people are certainly more comfortable nowadays attending such things as concerts and townhall-style meetings in a virtual manner, there are still plenty of opportunities for getting out to meet people at a grassroots level. Analysing any available data on the demographics and behaviours of the people you are likely to meet beforehand is a great way to ensure you maximize your opportunities during outreach meetings in real life.

Relationships with Patients and Key Opinion Leaders

The closer integration of patients with pharma is continuing, such that we are truly nearing the point where the industry can claim to be fully patient-centric – certainly when compared to how it used to be. The accessibility of health records has enabled every patient to be a kind of Key Opinion Leader – in that the way they behave and interact with health-related information can now be monitored and tracked, such that decisions are made based on a large amount of relevant patient data, rather than simply being based on a few people’s opinions.

This allows you to identify and reach out to pretty much anyone who may be in the target audience for your trial – at least, anyone who has opted-in to receive such messaging. Encouraging the non-KOLs to share their thoughts is also now easier than ever, as per the levels of accessibility outlined above – so you should also be looking to reach out to those patients who maybe don’t put their views online in the way the KOLs do.

The Key Opinion Leaders still have relevant followings of people, of course, such that you should be developing ongoing relationships with them as early as possible in the trial development process, in order that they might share the details of your trial with their followers as a trusted advisor.

Traditional Media and Podcast Awareness Campaigns

The death of traditional media has been discussed many times over the years – and yet it remains a factor in daily life, with broadcast and print media still retaining a large hold on people’s attention. The adoption of Virtual Reality by the main broadcasters and podcast platforms has enabled people to feel like they are participating in the debate along with the broadcasters – allowing for very specific targeting of people during particular programs, with individualized messaging able to be aimed at people who fit specific profiles.

Wide broadcast adverts of the type that used to be commonplace during traditional TV broadcasts can also still be effective. For these you should use the sophisticated audience-tracking data that is available from all the main platforms to identify suitable programs that are likely to attract a large number of your potential participants.

For more focused ads, you should target relevant individuals with personalized messaging – as per the Streaming TV suggestion above – either on one of their smart devices or direct to their Virtual Reality (VR) device. When utilising VR advertising, of course, it’s been shown that some people prefer a ‘real person’ avatar to hover into view to pass on the message, while others prefer a simple ‘flat image’ that they can then read through and act on if they wish. Data regarding each person’s preference should be available from the platform so you can target people using their preferred method as appropriate.

Patient Application Platform

The much-needed introduction of standardized clinical trial systems architecture that has taken place over the last few years has enabled the development of multiple highly effective and functional patient application platforms.

These platforms help facilitate an end-to-end process through which patients can find out what they need to know about trials using whichever method they prefer – such as reading, watching videos, or interacting with Artificial Intelligence avatars or a real person. Patients can then apply for the trial and be tracked through the process from start to completion. The data that is gathered through these platforms should be utilized for improving current recruitment and retention results, as well as informing the processes adopted for future trials.

Privacy and data protection issues have become ever more patient-led over the last ten years, while at the same time the sensible approach of allowing people to share their health records information with relevant parties has seen an enormous growth in the availability of data that can be used for recruitment and retention. Building on the original laws such as GDPR and HIPAA, the current regulations are simultaneously strict enough to protect a person’s privacy, while progressive enough to allow for what might be deemed ‘common sense’ sharing of data between applications.

The platform you use, of course, is not as important as what you do with it, so you should always ensure the outcomes you’re looking for are setup correctly within the system. Thus enabling you to make the most use of the technology and the huge amount of data on offer in order to engage with people who have an active interest in participating in your trial.

Swift Follow-Up for Patient Applications

Amazingly, it’s not so long ago that patients would apply to participate in a trial, then be kept waiting for days and sometimes weeks before being contacted to take their application further – with many never actually being contacted at all. Fortunately, that’s now a thing of the past, with all the patient application platforms now providing the functionality for a swift follow-up – either from a very sophisticated Artificial Intelligence avatar (of the type that has passed the ‘Turing Test’), or from a real person with medical training. For maximum effectiveness, you should ensure your follow-up operators learn from any feedback they receive, and continually update the best practice methodology for everyone involved.

Of course, some trial applicants may opt to receive their follow-up by message on one of their smart devices, or via a Virtual Reality interaction, or to pursue things at a time of their choosing – so it’s important to provide these options during the application process, in order that you don’t put the person off their intention to participate.

Diversity Equity and Inclusion

With widespread data sharing of health records throughout the US and EU, there have been significant improvements in increasing trial participation from underrepresented populations in these regions over the last few years. The pace of adoption of suitable technologies outside the US and EU has also helped build a potential patient population that covers a truly diverse range of people, such that the treatments being developed can be proven to work for everyone, not just a narrow range of people from one type of background.

Additionally, the legal requirements that are now in place to ensure your trial population reasonably reflects the make-up of the population at large are more easily able to be complied with, as you can identify and monitor who is applying for your trial in real time, then shift your attentions to underrepresented populations accordingly. This is still relatively tricky, of course, as privacy issues mean you’re unable to target people from specific backgrounds. However, through analysing the demographic profiles of various target populations – based on geography, interests, behaviours – you can revise your targeting on an ongoing basis to encourage widespread diversity and inclusion among your participants.

Best Practice Education

It’s now easier than ever to identify the research sites, locations, and activities that are performing best for recruitment and retention. With so much data available on such things as ‘time to first patient’ and average ‘loss to follow-up’ rates per area, you should be continually monitoring and analysing this information in order to identify what’s working best so you can replicate these actions in other parts of your recruitment and retention program that are not performing so well.

Simply having the data available is only the start, of course, as you’ll need to have the relevant knowledge and understanding to be able to interpret the data and turn it into actionable recommendations. There are several solutions that will help in this process – many of which will provide recommendations and suggestions based on data about successful activities from previous trials, and will deliver a continuous feedback loop as new data becomes available.

Research Site Assistance and Liaison

With trial protocols continuing to become more complex and specific, along with the requirements for ever more data to be recorded and interpreted, it might seem that sites are facing an ever-increasing burden of administration. However, the recent trend towards including sites (as well as patients) in the trial and protocol design stages of clinical trial development, plus the existence of system-agnostic user-friendly patient management platforms that integrate seamlessly with Clinical Trial Management Systems and other site-specific systems, has provided sites with the opportunity to recruit and retain patients without an increase in administrative burden.

Having dedicated site support teams and being able, in many cases, to provide an on-site recruitment and retention specialist (due to the overall cost savings for trials that have occurred as a result of the sensible use of new technologies since the ‘out of control’ years of spiralling costs from ten years ago) has further enhanced the sites’ capabilities for recruitment and retention.

Wherever possible, you should ensure you are providing as much in the way of support as you can, plus are liaising with the sites on a regular basis to gather feedback for ongoing improvements and ensuring your trial stays ‘front of mind’ and that no patient ‘slips through the net’.

Patient Data and Patient Registries for Region, Site, and Patient Identification

The universal sharing of health data has enabled the building of multiple databases that allow you to filter for likely patient populations in different areas. With a traditional site-based trial this is ideal for identifying the best sites to be using, and is also extremely valuable for choosing a range of areas for operating your DCT trials.

The skill here is in setting the identification criteria such that it provides you with sufficient potential trial participants in areas where you know you will be able to administer and operate the trial in a timely and cost-effective manner.

It’s also worthwhile looking to make use of the large databases of patient records that have been built-up by various patient groups, as they already have a relationship with the potential participants, so a message that comes from the patient group as a trusted advisor may help encourage people to find out more.

Patient-Friendly Trial Design

With an ever-increasing set of inclusion/exclusion criteria, there came a point several years ago where it became extremely difficult to recruit patients for certain types of trial. Fortunately, that situation has improved due to the adoption of multiple technologies – including the use of Virtual Twins for utilizing Artificial Intelligence to help identify patient populations.

The enormous amount of data available from people’s continuously-updated health records (updated ongoing through their smart devices and smart sensors) means that patients are having more of an input than ever previously into trial and protocol design – whether they are aware of it or not.

Thankfully for retention purposes, it is now possible to provide adequate remuneration for patients who participate in trials, with the regulatory caps on compensation amounts helping to ensure you can’t ‘bribe’ a patient to participate in your trial over those of your competitors. And it isn’t always about a simple financial transaction, of course – whether paid in cash, credit, gift card, blockchain or whatever. You should be analysing the data ongoing for what works best when it comes to keeping patients interested in trials, and making sure you offer patients a suitable recompense for the input they are having towards the development of your treatment.

As mentioned above, it is also very valuable for both recruitment and retention purposes to be including the sites in your trial design, as they have a vast amount of experience with operating trials and should have a good understanding of what patients are likely to be comfortable doing.

Decentralization

Back in the earliest days of the worldwide Covid pandemic (early 2020), there was a rush towards initiating decentralized trials – primarily based on the possibility of using new technology to bypass the traditional model of having patients attend sites, and allowing people to participate in trials from their own homes. (Despite, of course, this technology mostly having been available, though not utilized, for much of the previous decade).

What became clear after a while was that leaving sites out of the equation was actually not such a good idea – given their levels of experience ‘on the ground’ and their understanding of how to run trials successfully. Which resulted in the current situation – where the majority of trials are conducted in what we originally called the ‘hybrid’ model, with sites and Principal Investigators acting as the main operators of the trial, and suitable technology being used to facilitate the necessary gathering of data.

What this means in practice is that there is now no real barrier for trial participation based on simple geography alone – where previously a patient would either have to live within around 50 miles of a research site, or have their travel and accommodation taken care of in order to attend site visits.

To fully take advantage of this decentralized approach, you should incorporate the full range of options in your strategy. These include Mobile Trial solutions where a trial-equipped vehicle visits people in their own location, Retail Trial solutions where patients can call into their local pharmacy, and HCP Surgery visits where the trial is conducted at the patient’s own local doctor’s office.

Added to this, there is obviously a large amount of in-home technology – such as smart sensors and wearable devices – to enable suitable patients to record the essential information for themselves. This is an approach that is commonly used for Real World Evidence data gathering – which has become much more a part of the clinical trials landscape over the last ten years.

Virtual Reality systems have been shown to help aid both recruitment and retention – through being able to communicate directly with people while they are exploring their preferred metaverse, and thus being able to inform them of a suitable trial and keep them updated with the latest information, as well as assisting them with the ongoing gathering of endpoint reporting where it is appropriate to do so. (e.g. through appearing to be ‘in the room’ with the patient while they take certain treatments or record certain data).

For certain types of trial, the use of Virtual Reality can lead to a fully decentralized approach that spans several continents while still being managed and operated within the same timescale and overall framework.

To really take advantage of these opportunities, you should ensure that your trial can be operated and administered using as many of these means as possible – engaging one or more of the various solutions providers who can assist with delivery of these outcomes – thus opening up your potential audience of trial participants far beyond what it would have previously consisted of.

Travel and Expenses

The widespread adoption of Decentralized options (as above) has decreased the requirement to provide travel and expenses options. Though there are still many occasions, of course, where a visit to a specific research centre is required. With patients having much more of an option to ‘vote with their feet’, it clearly makes sense for recruitment and retention purposes to provide a full concierge-style service that handles all the travel and accommodation details on a patient’s behalf.

On top of this, having their expenses paid in a timely fashion of their choosing will help to convince participants that your trial truly is patient-centric and worth taking part in.

Retention Through Communication

Thankfully, the massive drop-out rates of previous years are becoming a thing of the past. In fact, one of the issues facing trial sponsors now may not be the fact that patients drop out of a trial because they don’t want to continue with it, but that they may wish to switch to another trial that they feel is being operated under more favourable conditions.

The main thing you can do in that case, of course, is to ensure your trial is as patient friendly as possible. Also, as was the case before, a key issue here is ongoing communication. Patients want to feel that they are fully involved in the process and are not simply a ‘subject’ to be experimented on. (Another thing we can be thankful for is the now universal casting-off of the word ‘subject’ in favour of the more friendly ‘patient’, ‘participant’, ‘volunteer’, or even ‘person’).

Clear and easy to understand communications are now far more common than previously, but it’s still a good idea to check everything you are sharing with patients to gain the perspective of interested parties from a non-medical background. There are plenty of good medical communications organisations around who can help with this – or, indeed, you can simply request that a non-medical person you know takes a look over the messaging for ease of understanding.

Another factor that helps retain patients on placebo-based trials is if they are made aware that, if possible, they will be able to receive any successfully proven treatment in the future, if they have been in the randomized placebo group.

Keeping patients informed as to the results of the trial – including which group they were in and the options for the future – is another factor that helps give patients a sense of connectedness to a trial, especially if they are aware from the outset that they will be getting this information.

Back to the Present – 2032 Predictions Concluding Thoughts

The inevitable increase in the use of data and digital solutions in clinical trials and recruitment and retention activities is well underway in 2022 – having also certainly been accelerated by the pandemic. What we need to remember, though, is that no amount of technology can replace the need for human involvement at every stage of the process. Whether that’s including patients and people from sites in trial and protocol design, or engaging in ongoing communications with trial participants (and not just through using Artificial Intelligence avatars!)

And when it comes to successful patient recruitment and retention strategies, there is no benefit to having an enormous amount of data if you don’t have the knowledge and understanding to be able to interpret it and act on it for better outcomes – which is something that only humans will be able to do, even in 2032.

Let me know in the Comments if you think the predictions I make here are in line with what you foresee. Or get in touch to discuss how I can help recruit and retain patients for your trials.

It’s difficult enough to recruit patients for clinical trials when the conditions are fairly widespread, such as eczema or asthma. When we look to recruit patients for trials based on rare diseases, the difficulty is compounded by the fact that the audience of potential participants is much smaller than for the more common conditions.

Finding patients living with rare diseases is the core of the problem, but it’s also important to have an engaging message to reach out with, in order to encourage people to apply to take part in a relevant clinical trial. Here’s our recommended approaches to recruiting rare disease patients.

Recruiting through HCPs

Traditionally, Healthcare Professionals (HCPs) such as doctors are not usually a large source of patients for clinical trials. Not having the awareness of suitable trials is a factor in this, as well as the well-known lack of time that doctors have available to spend with each patient.

However, one approach that can work well for rare disease trials is to identify doctors who are submitting their patients for relevant lab tests (in the USA), then contacting them straight away with a relevant message regarding a suitable trial. Utilizing multiple methods of outreach is the best approach here – i.e. targeting the HCP’s preferred method of communication, such as email, ads on social media sites they visit, or even postal mail if that works best.

Recruiting through Patient Leaders and Patient Groups

Another fruitful avenue for recruiting patients for rare disease trials is to engage with Patient Leaders and Patient Groups. A simple Google search can help identify various Patient Advocacy Groups and the like, but a more effective approach is to use ‘social listening’ in order to identify those people who are most actively discussing relevant issues for the rare condition.

This enables you to discover which platforms have the highest level of relevant engagement for your trial – e.g. Facebook, Reddit, Instagram, TikTok – as well as the people on those platforms who it would be most beneficial to approach for promoting the trial.

Other types of platforms that are used by Patient Leaders include their own blogs and podcasts, plus Patient Group forums. Each of these can provide a useful medium for you to get the message out – for example through being interviewed on a blog or podcast, having an article featured on a forum, or using paid ads that can be featured in these media.

Patient Groups may also operate their own registry of patients that you can utilize for identifying people who fit your inclusion/exclusion criteria, thus giving you access to a potential audience of trial participants who are already pre-qualified.

Building relationships with these Patient Leaders and Patient Groups before you have a specific trial to recruit for should prove valuable when it comes to the time you are recruiting, so I recommend you adopt this method early on in the process of developing your potential treatment.

Recruiting Direct to Patients

Not everyone living with a rare disease will be able to be reached through an HCP or Patient Group. Direct outreach through such methods as digital advertising (e.g. Facebook, Google, display ads) helps spread your message as far as possible. One of the great advantages of a platform such as Facebook is the ability to share an advert with other people. Thus, if someone who isn’t living with a rare condition sees an advert for a clinical trial, they can share it with someone they know, such as a family member or friend, and make someone aware of the trial who wouldn’t have been otherwise.

As with the Patient Leader approach, there are also popular podcasts, blogs and forums you can utilise for promoting your trial through determining the likely demographics and behaviours of your pool of rare disease patients, then looking to promote the trial on media that will be popular with the target group. (e.g. older people’s health forums, golf podcasts, parenting blogs).

Similarly, traditional methods of advertising can help to reach people through having your message presented to them in a press or radio ad. It’s almost always the case nowadays that digital ads perform better than these old school methods, but given the small size of the population you’re trying to reach, it could make sense to use every means possible.

Pre-Recruitment Strategy

This is something that can be successfully adopted prior to launching a full recruitment campaign – the idea being to develop a ‘warm’ audience of interested people that can then be contacted once you are recruiting for a specific trial. It’s quite common in the rare disease pharma and biotech space for firms to focus on a particular condition, so it can make sense to start building an audience of people with that condition even before you are looking to run a trial.

As well as the advantage of having a readymade audience of people who may qualify – thus speeding up the recruitment process – you can also use this data for developing ‘lookalike’ audiences of people who have similar characteristics. This is very useful for being able to target relevant people using social media advertising once the recruitment process proper begins.

Another good benefit of adopting this strategy is that, as you aren’t recruiting for a specific trial, you won’t need to go through Institutional Review Board (IRB) or Ethics Committee (EC) approval in order to reach out to your audience. The basic principle being to introduce the concept of a potential future clinical trial that people may be interested in, then follow-up with IRB/EC approved materials when available. Again, speeding up the overall process and giving you the best chance of achieving your recruitment goals.

If you operate in the field of rare disease and want to know more about how you can recruit patients successfully, get in touch to discuss the range of options.

It’s well-known that patient recruitment is the number one challenge facing clinical trials operations, with 80% of trials having to be delayed or cancelled due to under-recruiting of patients. When a trial gets to the stage where it needs to be ‘rescued’, as a result of not recruiting enough patients in a timely fashion, here are the actions I recommend you consider for getting things back on track.

I’ve listed them here in the order you are likely to see the quickest returns – based on the time it can take to set things up and have them working effectively – with the first recommendation being the most likely to deliver results in the shortest time.

Digital Outreach Direct to Patients

Digital ads are now the mainstay of direct to patient recruitment outreach efforts, with traditional forms of advertising such as press and radio being far less used than they once were. In particular, social media advertising has become a key driver of recruitment into trials – with Facebook being the main player in the field. (Not surprisingly, given its almost 3 billion per month user base).

Other social media sites that have proven successful for recruiting patients include Snapchat (primarily to reach a younger audience), TikTok (perhaps surprisingly given its user demographic and reputation for being somewhat frivolous), and Reddit. It’s also worth looking at Google advertising (especially for rare conditions) and other forms of online promotion, such as display adverts on popular and/or relevant websites and forums.

Digital Outreach to Patient Leaders

As well as the direct approach outlined above, it’s now possible to identify Key Opinion Leaders and Patient Advocates through such activities as ‘social listening’. This is where we analyse the conversations that are taking place online in order to identify the best platforms and people to approach for promoting trial enrolment. These Key Opinion Leaders should have a readymade audience of potential trial participants they can promote the trial to.

Social media sites, such as those featured in the Direct to Patients sectin above, can be a valuable source for finding Key Opinion Leaders and Patient Advocates that we can approach to promote trials that need to pick up their recruitment activity.

Digital Outreach to HCPs

Healthcare Professionals (HCPs) should really be a good source of patients for trials, as they obviously see people with relevant conditions on a regular basis. However, due to time constraints within doctor’s appointments and general lack of awareness of specific trials, it’s quite often the case that HCPs don’t provide as many patients as originally anticipated.

One method of encouraging doctors to bring up the idea of trial participation with their patients is to reach out to them at the right time, with the right message. Utilising lab test and medical claims data (in the USA), we can identify HCPs who have patients with the relevant condition and send them a targeted message about the trial that their patient may be interested in. Using a dedicated HCP Outreach platform can be very useful here, allowing us to target doctors using their preferred means of communication – e.g. via email, or on a website they habitually frequent.

LinkedIn and Twitter can also be useful platforms for targeting HCPs. Both these sites have decided not to allow direct promotion of clinical trials, but can be used for sourcing and engaging with medical professionals who operate in the relevant field.

Widening the Recruitment Pool

Within the industry, there’s been much discussion about Decentralized Trials (DCTs)over the last few years – particularly since the onset of the Covid pandemic in 2020. While DCTs are not suitable for every trial, it’s well worth considering a decentralized approach where it could significantly increase your target audience and thus aid recruitment.

Traditionally, patients have had to attend a Research Site at regular intervals during a trial. This can limit the audience to those people within travelling distance of their nearest Site. (Often defined as being those people who live within 50-60 miles). Opening up the trial through decentralization allows a much broader audience to be targeted and recruited – for which there are multiple solutions for conducting the necessary ‘Site visits’ from within a patient’s home, or at their local doctor’s surgery.

As well as decentralization, offering a travel and accommodation solution can also increase the size of the potential audience of patients. This can be particularly effective if the solution is offered as a ‘done for you’ package, rather than having the patient sort out their own arrangements and have to claim back their expenses.

Another method of widening the recruitment pool is to ensure your recruitment efforts are underpinned by the principles of diversity and inclusion. This can include such factors as incorporating images of people from diverse backgrounds, as well as having your messaging in different languages and being presented to people who live in particular areas or have specific interests – especially in the case of underrepresented populations who may not ordinarily consider taking part in a clinical trial.

Improving Site Performance

During the recruitment stage of a clinical trial, you will usually find there are some Research Sites that perform better than others – with many at the lower end of the scale actually recruiting no patients at all. The site selection process can help with this in the trial setup stage – i.e. through choosing Sites that are more likely to be able to deliver the desired results. But it can obviously take time to bring new Sites on board, so improving the performance of the Sites already involved in recruiting for the trial can speed up the process.

One key element here is to identify the best practices that the high-performing Sites are using, then have the other Sites adopt them in place of what they had been doing previously. A consultative approach to working with each of the Sites engaged in the trial will work best here for optimal results.

How to accelerate the recruitment process is a key issue for the majority of clinical trials. If you’d like to know more about the solutions on offer, get in touch to explore the possibilities.

The last couple of years have seen a significant increase in awareness of the existence of clinical trials among people all over the world. No prizes for guessing the reason, but how can we capitalize on this heightened awareness to tackle the perennial problem of not being able to recruit enough patients to participate in trials?

Based on my extensive experience and the developments I’ve been following over the years, I’ve put together an overview of the patient recruitment activities that are likely to be most effective in 2022 and beyond:

HCP Outreach

Using an HCP outreach platform to target doctors with relevant messaging is especially useful when recruiting patients for rare disease trials. Utilizing lab test and/or medical claims data (in the USA) can help identify HCPs who have patients that may be suitable – for example, those who have been submitted for a specific test for a rare oncology mutation. Reaching out to them in a timely manner via email, digital advertising, and even old-fashioned postal mail can help put your trial at the ‘top of mind’ and encourage them to discuss the trial with their patients.

Other methods of HCP outreach include targeting people with relevant specialisms on LinkedIn. This platform doesn’t allow direct promotion of clinical trials, but through using an advert type such as a Lead Generation Form you can start to engage in a dialogue with doctors who would then be more amenable to hear about and promote your trial.

Digital Outreach – Direct to Patients

Reaching people ‘where they are’ is a fundamental principle of marketing. And people are spending more time than ever online, particularly on social media platforms. Despite its well-publicised issues over the last few years, Facebook remains the number one visited social media site in the world, with nearly 3 billion users each month. Its sophisticated machine learning capabilities ensure it’s always worth looking at Facebook ads for trial recruitment. (For more on this, you might want to check out my book on Patient Recruitment for Clinical Trials using Facebook Ads).

But it’s not just about Facebook – many other social media sites have proven to be effective for patient recruitment, including SnapChat, Reddit, Instagram and even TikTok. Plus, of course, Google and YouTube can provide a large audience of potential trial participants, as well as the many other methods of reaching people online. (e.g. ‘native advertising’ on news and information websites, or ads on forums and health-related sites).

It should also be remembered that HCPs use social media, too, so your digital adverts have an additional chance of being effective for recruitment – through targeting patients directly as well as showing your message to doctors who may be interested in learning more.

Relationships with Patients and KOLs

One of the great benefits of the increased use of digital solutions in healthcare over the last 2-3 years is the development of tools that are genuinely useful for the purpose of trial recruitment. One such tool enables us to use ‘social listening’ to identify the platforms and individuals who are most active in discussing relevant topics for the condition we’re recruiting for. This can help us to identify, for example, that Reddit has a larger population of people discussing our condition than are active in Facebook Groups. Many of these people will belong to Patient Advocacy Groups (or be Patient Advocates) and may well be Key Opinion Leaders whom it’s worth our starting a dialogue with to discuss a relevant trial.

Building relationships with Patients, PAGs and KOLs is a very human activity that can be facilitated through using a relevant digital tool for identifying and reaching out to the people best placed to help promote our trials.

Traditional Media and Podcast Awareness Campaigns

It’s true that traditional forms of advertising, such as press and radio, are decreasing in effectiveness when it comes to recruiting patients. But they can still be a valuable part of the overall mix for raising awareness of a trial. As can a PR and publicity campaign through media such as podcasts. There are many general and health-related podcasts that will accept advertising – often in the form of the host reading out the message during the show. Plus many KOLs and Patient Advocates will host their own podcasts, on which they may be happy to promote a relevant trial.

Patient Application Platform

Having an effective and efficient patient application platform in place is of great benefit for the smooth running of the trial recruitment process. The platform should include an online application website/webpage (also accessible on mobile) where potential participants can be pre-screened for the trial. The backend of the system should be robust and sophisticated enough to host the applicants’ data in a secure manner that fits all the relevant regulations (GDPR, HIPAA etc.), as well as providing snapshot reports of activity, number of applications, stage the applicants are at etc.

Using a platform in this manner can ensure that no patients ‘slip through the net’, as well as giving a good overview of which promotional activities are working best, which regions might need some assistance to improve performance, how you might be able to increase conversion rates etc.

Swift Follow-Up for Patient Applications

Once potential trial participants have completed the online pre-screener form, a swift follow-up with them is essential for maximising the number of patients who qualify for the trial. Digital methods are available where, for example, a series of text messages is sent to consolidate the application. What has often been seen to work best of all, though, is a follow-up phone call from a medically-trained person (such as a nurse), who can go through additional screening questions based on the trial’s inclusion/exclusion criteria.

Diversity Equity and Inclusion

Increasing trial participation from underrepresented populations has long been an issue in the industry. Thanks to initiatives such as the FDA’s guidance on enhancing diversity, trials are increasingly moving towards a situation where people of all backgrounds are being encouraged to take part. This not only makes sense for better outcomes – i.e. developing treatments that work for everybody, not just a particular type of person – it helps to widen the potential audience from which to recruit. There is definitely work that needs to be done here to reduce the mistrust among certain populations, but incorporating a DEI mindset when developing your recruitment program will help speed up recruitment and deliver better results for society as a whole.

Best Practice Education

Using a suitable Patient Application Platform, it’s possible to identify those Research Sites that are doing well and those that are doing badly for recruiting patients. It makes sense to work with the best performers to identify best practices – i.e. what it is they’re doing that’s working well – which can then be passed on to the Sites that aren’t performing as well. This not only helps speed up  recruitment, it also keeps the lower performing Sites engaged in the process and more likely to be able to deliver good results for future trials.

Research Site Assistance and Liaison

People working in Research Sites are generally busy with lots of administrative things they need to do, so helping them by making the admin for the patient recruitment process simple will help keep them interested in managing your trial. Having a suitable Patient Application Platform that is easy to use and integrates with their existing systems, with little or no need for in-depth training, will be very valuable here.

Further to this, regular communication with the Research Sites will help keep the trial ‘front of mind’ and ensure that each patient referred to them is handled swiftly and appropriately.

Patient Data and Patient Registries for Region, Site, and Patient Identification

Another use for some of the digital tools that have been developed in recent years is for better analysis of data on patient populations, using data from Healthcare Providers, Electronic Health Records, and Patient Registries. This can help to determine the regions where you can find the maximum number of patients for your trial, based on the condition and inclusion/exclusion criteria. This data analysis can also help identify specific Research Sites that are likely to have patients living nearby, as well as provide access to a readymade audience of potential trial participants.

Patient-Friendly Trial Design

Increasingly in recent years trial protocols have often become so restrictive they make recruiting patients even harder than it already is. There are obviously good reasons for this, but it’s also far too often the case that previous protocols are ‘copied and pasted’ without determining whether they are entirely relevant for the new trial. Removing some excessive strictness from the inclusion/exclusion criteria can help open up the trial to a wider audience.

Having an arduous and time-consuming routine for participating in a trial can also be an issue for recruitment, as it can put people off wishing to take part. With the development of wearable tech and the more widespread acceptance of digital meetings (rather than having to meet in-person), it’s possible to reduce the burden on the patient so they don’t have to spend so much time attending Research Sites while on the trial.

Decentralization

One of the great buzzwords in clinical trials for many years now, Decentralized Trials have become an even hotter topic during the pandemic. The ability to manage and monitor a patient on trial without them having to be physically in attendance at a Research Site helps open up the potential audience to people who live outside a 50-60 mile radius of a participating Site.

Lots of solutions have been developed to help with the proliferation of Decentralized Trials, including those that allow patients to attend their local doctor’s surgery, rather than a Research Site, through having a simple digital system in place at the surgery. The Principal Investigator can then conduct the trial in the manner they need to – including having any nurse-specific tests carried out by the local practice – without the patient having to be present in their Site. Principal Investigators benefit from this approach by gaining additional patients for the trial, while the local doctors benefit through having an extra income stream they wouldn’t have had otherwise.

Travel and Expenses

In circumstances where Decentralization isn’t practical, being able to provide transportation and expenses for patients can help encourage more people to participate in your trial. A simple solution such as a concierge service that arranges travel and/or a pre-paid card for expenses can work best here for making things as easy as possible for the patient. This also helps with ongoing trial retention, as patients know they are not going to have the ongoing hassle of arranging their own travel or accommodation each time they need to attend a clinic.

Retention Through Communication

While it’s a well-known fact that 80%+ of clinical trials have to be delayed or closed due to not recruiting enough patients, it’s also the case that up to 30% of patients who do enrol will drop out over the course of the trial. Retaining patients throughout is thus a key factor in ensuring your trial hits its milestones.

Good communication is the key to retaining patients on trials – both through the messages that are sent and through the mediums that are used. Some people will prefer to have regular text messages, some will prefer emails, others will prefer phone calls, and some will even prefer postal mail. Having each of these available as a means of keeping in touch – alongside clear, patient-friendly messages and responses – will help retain more patients on your trials.

Patient Recruitment Strategy

In order to make best use of the activities outlined above – not all of which will be suitable for every trial – you should develop a strategy that is tailored for the specific trial and patient population concerned. My specialism is in working with you to determine which of these elements will work best for your trial, then managing them and the ongoing recruitment process for maximum returns.

Get in touch to see how I can help recruit patients for your trial, in 2022 and beyond