Decentralised and hybrid clinical trials are delivering benefits for sponsors in a number of ways – delivering quality data quicker to reduce time to market, achieving higher levels of compliance, increasing the diversity of patients participating in trials, and importantly, recruiting and retaining more subjects.
Encouragingly, there has been significant progress in decentralised and hybrid clinical trials in the last few years, with the global COVID-19 pandemic serving as a catalyst that brought major shifts in how we approach the execution of clinical trials. Although the recent uptake has been considerable, decentralised clinical trial components have been successfully implemented and ongoing for quite some time, and we have seen different phases and scales of adoption across the board. More organisations are rolling out pilot programs, implementing hybrid trials more extensively and overall delving deeper into decentralisation to explore the benefits it offers.
Therefore, at this point in the shift to decentralised and hybrid studies, we are getting valuable real-world experience that enables us to drive continuous improvement. Sponsors now have a clearer view of critical success factors such as early planning to ensure optimal engagement with subjects and sites, selecting the right in-home clinical services, wearables or sensors, and staying close to the patient throughout the study.
I’ll explore these lessons in this article, in addition to outlining some of the key elements that need to be in place in a DCT setting to ensure good levels of patient retention.
Enhanced Convenience Drives Enhanced Recruitment
In any clinical trial, be it decentralised or not, the priority is always the patient. We conducted patient voice surveys in 2019 and again in 2020 to better understand attitudes toward decentralised or hybrid trials. The findings indicate that patients are open to decentralised clinical trial approaches, and overall, they want the options and flexibility they provide.
Decentralised and hybrid clinical trials overcome two common hurdles for recruitment and retention: accessibility and convenience. Typically, subjects that participate in clinical trials live within 50 miles of the site. In our most recent survey in 2021, 90% of respondents were not willing to travel more than one hour to participate in a clinical trial. The physical parameters and burden of travel associated with traditional trials exclude significant populations of patients that are either incapable or unwilling to travel to the site. Providing hybrid and fully decentralised clinical trial options eases the burden of travel and delivers a more positive and convenient patient experience.
Furthermore, the removal of geographic constraints unlocks the potential to recruit participants from more locations, and from more diverse backgrounds. Increasing the diversity of subjects that are participating in clinical research is an important goal we are all working towards in the industry. Our experience of designing and conducting decentralised and hybrid trials to date certainly indicates that by increasing the number of patients we reach, we also achieve increased diversity.