This webinar, hosted by Paul Wicks featuring Craig Lipset and Liam Eves focussed on some of the major challenges of decentralized and hybrid clinical trials, solutions to overcome them, and some practical examples.
The link to the full webinar is here, and if you don’t have time to listen to the full webinar, we’ve summarised the speaker bios and the main takeaways in this blog post below!
About the speakers
Craig Lipset
Craig is a decentralized trial pioneer, designing and launching multiple industry firsts -- from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants. Previously, Craig was Head of Clinical Innovation and Venture Partner at Pfizer, and he currently serves on the Board of Directors for the Decentralized Trials & Research Alliance
Liam Eves
VP of Clinical Operations at Sano Genetics, with 15+ years experience in creating and scaling enrolment solutions at the intersection of patient recruitment, site management and clinical innovation.
Paul Wicks
Paul is a consultant to clinical research and digital therapeutics companies, including Sano Genetics, Ada Health, and Woebot Health. Paul spent >10 years at PatientsLikeMe, starting in R&D and finishing his time at PLM as VP of Innovation.
Highlights from the webinar
What is a decentralized or hybrid clinical trial?
Craig defines decentralized clinical trials as a collection of technologies and processes that, when applied, can create options for people to participate in research outside a traditional research sites.
This can include at-home sample collection for genetic testing or other biomarkers, patient reported outcome surveys, as well as administering treatments in an interventional clinical trial. Not every trial is possible to be run fully decentralized, and indeed in many cases a hybrid model (combining at-home and in-clinic visits) is preferred by participants.
One interesting example of using technology to improve the participant experience was a program that uses a stuffed animal and augmented reality (overlaying digital visual elements into the real world through a cellphone or other device) to help children with diabetes learn how to navigate taking readings, understanding glucometers, and dosing. This program not only helps the child navigate this challenging time, but it also educates their parents about the condition and how to care for their child.
What are the challenges of implementing decentralized and hybrid clinical trials? And how can we overcome them?
A number of challenges were highlighted, including challenges of change management and the need for a toolbox of solutions, rather than relying solely on technology. Decentralization is an enabler of representation where geography and physical distance are barriers, but it must go along with efforts to restore faith, trust, and confidence in communities that have been marginalized for so long. The industry needs to look at the problem holistically and focus on what needs to be solved. The amount of data collected in clinical trials is increasing exponentially, and there needs to be a balance between the amount of data collected and what is reported.
The discussion also touched on the lack of innovation in clinical trials due to a reluctance to adopt innovative approaches among sponsors and CROs because the business model adopted by the clinical trial establishment just isn't compatible. The speakers stressed the need for change management and for companies to make an investment in updating their SOPs, identifying gaps in vendors and partners, and incentivizing and supporting colleagues who embrace new approaches.
The speakers also emphasized the importance of inclusion and diversity of trial participants and how decentralized trials could help address this. However, decentralized trials are not a silver bullet and companies need to make sure they restore faith, trust, and confidence in marginalized communities. This cannot be done overnight, and it requires a long-term investment in both economic terms and time-commitment. Companies need to be incentivized to generate evidence that shows efficacy and safety in representative populations in diverse subpopulations and there must be guidance and clarity to drive adoption of decentralized trials.
Ultimately, change takes time and the industry needs to be mindful of what it reports and what it knows. Our panel urged companies to look at this problem holistically and focus on what needs to be solved whilst also stressing the importance of a toolbox of solutions, not just relying on technology. Finally, the speakers encouraged companies to make an investment in updating their SOPs, identifying gaps in vendors and partners, and incentivizing and supporting colleagues who embrace new approaches.
Summary
In conclusion, the DCT Webinar provided valuable insights into the challenges of change management in clinical trials and the need for a toolbox of solutions that includes decentralized trials. The speakers stressed the importance of inclusion and diversity of trial participants and the need to restore faith, trust, and confidence in marginalized communities. Companies need to be incentivized to generate evidence that shows efficacy and safety in representative populations in diverse subpopulations. Change takes time, and the industry needs to be mindful of what it reports and what it knows. Ultimately, the industry needs to look at this problem holistically and focus on what needs to be solved.
If you are running a trial involving genetic testing, and would like to consider at-home genetic testing as part of your DCT strategy, you can read more about our solution and past work here, or get in touch to speak with our team.