Here’s a top-line overview of the content of the sessions I attended in person at the SCOPE Summit Europe 2022 in Barcelona, April 20-21 – each of which was excellent, with a great deal of information provided.
I’ve also added in a couple of my own reflections and a conclusion, to provide a more personal view of the experience and what I’ve taken from it.
Wednesday 20 April
Accounting for the Patient Experience in Decentralized Trials
Presented by Sebastian Stratmann of Merck KGaA, this session looked at the work of TransCelerate and the various useful and effective tools they have developed to help modernize clinical trials, such as their Patient Protocol Engagement Toolkit (P-PET), and Study Participant Feedback Questionnaire (SPFQ). Certainly I’ll be investigating these further and participating in the feedback process that TransCelerate are looking for from people in the industry.
Operationalizing a Digital Recruitment Strategy
April Monge of Novartis joined us virtually from Basel to outline how digital solutions can help with a patient recruitment strategy. (Obviously, something close to my own heart!) April outlined how they are testing different approaches – such as having a call centre follow-up process versus not using a call centre. While there wasn’t much new for me here, I believe it’s always worth revisiting the fundamentals and best practices.
Building the Patient Recruitment Ecosystem to Deliver a Better Clinical Trial Experience
Labcorp’s Ben Quartley gave us an overview of the various different facets involved in the whole system of healthcare and patient recruitment, and how they are becoming more interconnected as time goes on. The overall theme of this session was that the majority of people don’t take part in research, so trying to provide some ideas for how to get more people involved. Again there were no particular revelations for me, but the content was clearly presented and reinforced what I’ve learnt from my own experience.
Trials@Home: Working with Patients to Assess and Evaluate the Concept of DCTs in a Pan-European Setting
Presented by Bart Lagerwaard of University Medical Centre, Utrecht, Tanja Keiper of Merck KGaA, and Maartje Roskams of International Diabetes Federation, this session looked at the RADIAL pilot study and how it has been developed to assess patient satisfaction at various points in a Decentralized and hybrid setting compared to a conventional trial setup. The first patient in for this study will be in November 2022, so I’ll be interested to see the results in the future.
Combining Innovation and Collaboration to Advance Research across the Industry…We Can’t do it Alone
Chaired by Darcy Forman of Science 37, with Sam Hariry of Novartis, and Cristina De Juan of UCB Pharma, this session focused on the complexities of setting up and running DCTs within Europe. A couple of key factors highlighted were the regulatory and cultural differences in the different countries and how they need to be addressed. Another key issue has been getting ‘buy in’ from research sites to sign up to administering DCTs. My main take from this session was the value of communication throughout the process for better outcomes.
Digital Health in the Circular Economy
Bert Hartog of Janssen presented perhaps the most unexpected session of the Summit, focusing on the environmental impact of the increasing adoption of digital health technologies. Similar to how the mobile phone and battery industries have developed a method for recycling their materials-rich devices, and as more digital devices are used for healthcare, the proposition is that our industry needs to develop methods for ensuring we can do the same with these devices. A new concept for me, and one that I think the industry needs to be mindful of if we’re not to alienate potential trial participants – many of whom will be keen to reduce their environmental impact.
What can Clinical Innovation Teams Learn from Digital Health Startups?
Chaired by Francesca Wuttke of nen, and featuring Bert Hartog of Janssen, Andrea Coravos of HumanFirst, and Nader Alaghband of Ampersand Health, this panel discussion looked at what big pharma might be able to learn from more agile startups in terms of delivering quicker and better outcomes. Collaboration between the different stakeholders was a key theme, as well as taking advantage of the unique benefits provided by either a pharma or startup organisation. I was also entertained by some interesting anecdotes about individual experiences in the field.
Assessment of Patient Burden and Impact on Recruitment Strategy
Matt Bonam and Nick Carroll of AstraZeneca presented a session on how they had analysed their feedback from trial participants and HCPs to determine where the main elements are in the trial process that are perceived as a burden. Patient surveys and recommendations for how to act on their results have helped AZ to understand where the problems are and, more importantly, how to reduce the burden for better outcomes. Patient centricity is the foundation of how I operate, so one of the things I was particularly interested to see is the product catalogue idea that helps identify the most useful tech solutions for a particular trial and patient.
Effective Tools to Better Plan, Track and Monitor Rare Disease Studies: Sponsor and CRO Perspectives
Rohit Nambisan of Lokavant led a discussion between Ravi Grewal of Altavant Sciences and Zizi Uzezi Imatorbhebhe of ErgoMed on how to make use of relevant tools for delivering trial results in the area of rare disease. Challenges raised include the different definitions of what even makes a rare disease, through to the fact that, by their very nature, there are not that many rare disease patients. One thing that particularly stuck in my mind was the reference to a current study highlighted being run which is only looking for 90 patients, but in order to get them is having to activate 68 sites across 16 countries – underlining the complexity and difficulty of recruiting for rare disease trials.
Learnings from the WHO’s Covid-19 Solidarity Trial, the World’s Largest Adaptive Trial
Derk Arts of Castor gave us an overview of the methodology behind this World Health Organisation Covid-19 trial that incorporated remote and adaptive elements to deliver a decentralized trial. (Derk’s preferred term being ‘modern, patient-centric trial’, rather than decentralized). The scale of this trial was truly global, with 3000 investigators, 15,000+ patients, and 30 countries. Some of the key takeaways here were to maximise the use of esource through having plain language, plus ensuring the user experience is truly scalable, without requiring too much hand-holding.
Interactive Discussion
Jason Gubb of Gubb & Associates, and Sebastian Stratmann of Merck KGaA led a discussion with conference attendees on how to connect better with patients. There was a consensus among everyone that patients need to be treated as people, rather than ‘subjects’, and should be included at each stage of the clinical trials process. I summed up my own thoughts on this by suggesting that our industry could learn a lot from those industries that put Customer Experience at the heart of what they do – with patients being the ultimate customers for pharma.
Reflections after Day One
Some great topics covered, with a wide range of relevant issues being discussed, while the coffee and lunch breaks provided a good forum for meeting fellow attendees and finding out more from the exhibitors. For myself – as with many others – the main networking opportunity presented itself with the Welcome Reception after the sessions were finished. Over free-flowing wine and tapas, new connections were made and many subjects were discussed (including plenty not related to clinical trials).
Rolling on from this to a dinner in a local restaurant, followed by a few (many) more drinks in the hotel bar, I was struck once again by how friendly the majority of people in the industry are. And how, if we could continue with this level of interaction and collaboration outside of the conferences, maybe we could build a climate of working together to achieve our common goals?
Thursday 21 April
I had to deal with some other matters for the first couple of hours of Thursday, so resumed my attendance at the sessions after the first coffee break.
Harnessing the Power of Real-Word Data for Clinical Research: European Initiatives
Dipak Kalra of the European Institute for Innovation through Health Data (iHD) presented this keynote on various initiatives that have helped develop standards for utilising health data throughout the healthcare ecosystem. The use of Electronic Health Records data within clinical trials was explored, as well as looking at some larger-scale projects that use federated data (ie the data remaining local and owned by the data owner, but accessible to a larger group in aggregate). One of the key things I took from this session was the sheer number of Europe-wide initiatives that are already underway that should be of benefit to the industry and healthcare ecosystem as a whole.
Hybrid and Decentralized Trials: The Future is Here
A panel discussion chaired by Elke Van Mol of Janssen, featuring Cristina De Juan of UCB Pharma, Dipak Kalra of iHD, Lisa Moneymaker of Medidata, Sid Jain of Janssen, and Kavita Rattan of Pfizer as a virtual panellist. A couple of issues that came up here were how the research sites require assistance to help with the adoption of hybrid and DCT solutions in a manner that doesn’t have a detrimental impact on their existing operations, plus ensuring that patients are given the choice of which technological solution they will be comfortable using. One area close to my own thinking that was discussed was the necessity for having DCT elements in mind at the early stages of protocol development, in order to avoid having to put in amendments in the future.
Illuminating Diverse Enrolment in HIV Clinical Trials
Jennifer Niesz of Merck & Co outlined the approach taken in the ILLUMINATE program, designed to increase enrolment of women and people from diverse backgrounds into an HIV trial. One of the key factors highlighted that resonated with me was the large amount of preparation that went into the program, including gathering feedback and raising awareness well before the study started to recruit. Alongside this, another element I picked up on was the additional budget available and large amount of support materials that were developed for research sites to aid their own local recruitment and retention.
Collaborating with the Community for Faster Commercial Clinical Research
Gail Melvin of the Patient Recruitment Centre in Leicester spoke on behalf of the UK government’s NIHR Patient Recruitment Centres (PRCs) regarding how they can collaborate with sponsors and CROs in order to deliver faster and more effective recruitment solutions. The example was given of a Covid study that recruited almost twice as many patients as the target, in just 8 weeks rather than the target 12. One of the key factors I picked up on was how the 5 PCRs in England are situated outside the UK’s ‘golden triangle’ of London, Oxford, Cambridge.
Lessons from the Covid-19 Pandemic
Rounding off the conference was a panel discussion chaired by Marina Malikova of Boston Medical Center, featuring Alicia Staley of Medidata, Robert Kroes of Lilly, Mats Sundgren of AstraZeneca, and Hilde Vanaken of TCS. The core theme was how the pandemic has helped progress the development of patient-centric study protocol design and the adoption of more digital approaches to running trials. One of the key issues that I certainly recognise and empathise with is the multiple different systems that research sites have to learn how to use in order to operate trials. (Sometimes even the same sponsor adopting a different vendor for a future trial that requires yet more learning). Working towards a solution where there are common platforms, or at least where the sponsor takes its information from a site’s existing systems, was a view I certainly agree with.
Conclusion
One thing that’s clear to me from this and other events is that, if all someone new to the industry did was attend conferences, they might come away thinking that everything was working fine and there were no problems that needed to be addressed. Or, at least, that any remaining issues were on the point of being resolved. However, it certainly doesn’t seem like that in the real world!
There’s obviously something self-selecting about people who speak at and attend this kind of event. Such that it may well be akin to ‘preaching to the converted’ or simply presenting information to people who already agree with the principles of what’s being said and are primarily there to learn more about the specifics.
But I fear that the problems within the industry are much deeper than that. We certainly don’t appear to be in a situation where everybody agrees that things need to improve and are happy to take the necessary steps to achieve this. Indeed, my experience suggests that a firm attachment to the status quo is, if not the norm, then certainly very prevalent in all types of organisation.
Which I think leads me to my biggest learning from the conference – that there are plenty of us who are keen to see things moving in the right direction for the benefit of the industry, healthcare in general, and society as a whole. What we need to do is keep sharing information and collaborating with each other, in the manner I witnessed over these two days in Barcelona.