How Sponsors and CROs can Fully Benefit from the Permanent Shift to Decentralized Clinical Trials Brought About by the COVID-19 Pandemic

Executive Summary

Evidence is mounting that hybrid and decentralized clinical trials are here to stay. What was once a nice-to-have is quickly transforming into a must-have. As reported in Clinical Trials Arena, roughly 1,300 clinical trials with a virtual and/or decentralized component will begin in 2022, representing a 93% increase over 2020. And in a recent Industry Standard Research (ISR) survey2 of clinical trial sponsors and CROs, more than 80% of respondents said they expect the hybrid model to be used more often than the traditional trial model within the next three years. The catalyst for this dramatic shift was the COVID-19 pandemic when, to avoid overburdening hospitals and healthcare facilities, many non-essential clinical trials were deferred.

To aid sponsors and CROs in fully realizing the benefits of decentralized clinical trial methods moving forward, this whitepaper extracts the lessons learned from the pandemic and their implications for clinical trials now and in the future.

During the early months of the pandemic, clinical trials that relied heavily on participant visits to investigator sites were most at risk as non-essential travel was discouraged and citizens were instructed to remain at home—especially immunocompromised people. During this period, the Clinical Trials Transformation Initiative (CTTI), a public-private partnership to improve the quality and efficiency of clinical trials, recommended that trials “pivot” to remote protocols, including the use of virtual and home health services.

Based on lessons from the pandemic, it is clear that clinical trial designs and protocols should utilize redundant pathways that include a significant home-visit component that can be scaled on relatively short notice. These findings signal the emergence of a new normal for clinical trials—an acceleration of the shift away from site activity to home-based services wherever possible.