How Decentralized Approaches Mitigate Pandemic-Driven Enrollment Challenges

The COVID-19 pandemic has had a transformative impact on the delivery of clinical trials. The implementation of social distancing, quarantines, and stay-at-home orders has resulted in unprecedented delays and disruptions to operations across the globe, and thousands of trials have been suspended or stopped in 2020. Perhaps the most significant evolution in clinical trial design and delivery throughout 2020 and into 2021 has been the wide-spread adoption of technologies to facilitate decentralization of clinical trials via solutions like digital recruitment, virtual visits and eCOA captured via telehealth.

Several studies have sought to understand the broad impact of COVID-19 on clinical trials, but few have shown how this impact has differed between traditional site-based trials and those employing decentralized approaches for trial data collection. Now, more than a year after initial quarantines and stay-at-home orders took effect, we are able to start to understand whether the application of decentralized methods has allowed certain clinical trials to overcome these challenges.

The maturation of decentralized clinical trial features like telehealth, eConsent and eCOA means that going forward, technology based solutions can and should be deployed in clinical trials routinely to allow for maximum operational flexibility. Even if the scope of these technology-enabled features is initially limited, inclusion at the outset ensures the ability to fluidly change data capture strategy mid-study if needed. This will be particularly important for trials initiated well into 2021 if COVID-19 diagnoses continue to rise globally and some countries re-apply certain lockdown measures.