Clinical trials are continuing their march towards greater decentralization after the industry rebounds from COVID-19. A recent study completed by Greenphire Data indicates that this rebound has been faster than expected:
While there was a lull in new participant enrollment in the second quarter, new data from Greenphire indicates that new patient enrollment in trials that it provides services for globally has rebounded - up 85% since the trough in April, and has surpassed pre-COVID-19 participant enrollment trends (up 3% since January 2020). This trend reaches across geographic regions, with Europe experiencing a surge in new patient enrollment (up 6% since January 2020) and North America not far behind (up 5% since January 2020).
At Medable, we have seen first-hand that much of this growth in patient enrollments spurred the adoption of Decentralized Clinical Trial (DCT) methodologies. Greenphire found that of those surveyed in the report that:
“84% of sponsors and CRO’s are actively seeking to increase the use of technology to better support decentralized trials.”
Greenphire’s Chief Product Officer Kyle Cunningham sums it up well:
The concept of using technology to help create value in a decentralized or hybrid trial environment isn't new per se, but COVID-19 has certainly encouraged wider adoption by forcing everyone to find ways to bring greater connectivity between clinics and patients.
At Medable, we know that to unlock the value of a decentralized clinical trial approach fully, each study team must assess their unique protocol and analyze which elements of the study schedule---whether consents, outcome assessments, or site visits---can be decentralized. Essentially it boils down to taking a flexible and modular approach.
As an industry, we need to offer greater choice, and decentralization -- in any form -- gives us the tools to do so successfully. Patients benefit from greater choice about where, when, and how they participate in a trial. Sites benefit with ways of managing trials and treating patients. Sponsors and CROs enjoy better data quality with more data capture mechanisms in real life.
Medable’s Mary Costello recently authored an article in Applied Clinical Trials, that provides tips to help research sites implement decentralized trials. It charts the course towards determining the right level of decentralization for a given indication or study, and includes these five tips:
- Change management: Know what to expect
- Technology: Know what to look for in partners and solutions
- Charting the course: Know what to plan and train for
- Guiding principle: Know that patients drive process
- Cycle of improvement: Know what to measure and adjust
Medable believes that a modular approach to right-sizing a DCT for each unique study will ensure a smoother transition than a one-size-fits-all approach. We start every engagement working with customers to complete oour DCT Readiness Framework to determine the right level of decentralization:
While Covid-19 fundamentally disrupted clinical trials in 2020, there is a silver lining. The groundwork has now been laid for an incremental approach to decentralization. Medable’s readiness framework and modular, integrated platform fosters a flexible approach to each study, promising brighter days ahead for investigators, sponsors, and -- most crucially -- patients.