Key Takeaways
- Definition of DCTs: Decentralized clinical trials use technology and home-based processes to allow participation outside traditional research sites.
- Hybrid Preference: Most participants prefer a hybrid model that combines at-home convenience with occasional in-clinic visits.
- Beyond Technology: Success requires a "toolbox" of solutions, including updated SOPs and organizational change management, rather than just new software.
- Diversity & Trust: While DCTs improve geographic access, long-term investment is needed to rebuild trust in marginalized communities to ensure true representation.
- Incentivizing Innovation: Sponsors and CROs must update business models and SOPs to support the adoption of innovative trial designs.
About the speakers
Craig Lipset is a decentralized trial pioneer, designing and launching multiple industry firsts, including the first fully remote/virtual clinical trial for a new medicine and the first return 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
At the time of recording, Liam Eves was VP of Clinical Operations at Sano Genetics, with 15+ years' experience in creating and scaling enrollment solutions at the intersection of patient recruitment, site management, and clinical innovation.
Paul Wicks 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?
A decentralized clinical trial (DCT) is a clinical trial in which some or all trial-related activities occur at locations other than traditional clinical trial sites. This can include participant engagement, recruitment, consent, sample collection, delivery of interventions, collection of patient-reported outcomes, and follow-up.
As Craig noted, DCTs are best understood as a collection of technologies and processes that create options for people to participate in research outside a traditional site. Not every trial can or should be fully decentralized. In many cases, a hybrid model, combining at-home and in-clinic visits, is preferred by participants and more appropriate for the study design.
Relevant examples include at-home sample collection for genetic testing or other biomarkers, digital patient-reported outcome surveys, and remote administration of certain interventions. One example discussed in the webinar used a stuffed animal and augmented reality to help children with diabetes learn to navigate glucose readings and dosing. This illustrates a broader point: decentralization is not just about removing site visits. It is about redesigning the participant experience to reduce burden and improve understanding.
What are the challenges of decentralized clinical trials and how can they be addressed?
The panel highlighted several critical challenges and solutions:
- Change Management: Shifting from a technology-only focus to a holistic "toolbox" of solutions.
- Representation: Overcoming geographic barriers while actively rebuilding trust in marginalized communities.
- Data Management: Balancing the exponential increase in collected data with what is actually reported.
- Operational Inertia: Updating outdated SOPs and business models within CROs and sponsors to incentivize innovation.
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 prevailing business model within the clinical trial establishment remains structurally misaligned with the adoption of innovative approaches. 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 alone cannot address structural barriers to participation 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. The speakers emphasised that sponsors must address the problem at the system level—not just the tooling level—if adoption is to be durable. 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.
Conclusion
The central message of this webinar is that decentralized trials are not a single solution. They are a design approach that must be matched to the right organizational structures, trust-building strategies, and data practices. Technology enables decentralization, but success depends on how sponsors and their partners manage the broader system around it.
For teams running precision medicine trials, this has direct implications. Programs that involve at-home genetic testing, remote pre-screening, or longitudinal participant engagement require coordinated workflows across recruitment, logistics, education, and data management. When these elements are disconnected, drop-off increases and timelines extend.
If you are designing a trial that includes at-home genetic testing, remote pre-screening, or decentralized participant engagement, Sano Genetics can help you build a coordinated approach across recruitment, testing, and long-term follow-up. You can explore our approach and past work here, or get in touch to speak with our team.
Watch the full webinar here.