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.