Impact of COVID-19 pandemic on design and conduct of clinical trials: developing best practices based on lessons learned for risk and change management

Abstract

<p class="abstract">The coronavirus disease 2019 (COVID- 19) pandemic is disrupting clinical research in most of the world. We have seen an immediate impact on clinical trials due to challenges coming from the COVID-19 travel bans, hospitals/clinics’ visitation restrictions, social distancing precautions and shifting operations to work remotely on a short notice. These factors have translated into the issues challenging clinical trials such as operations, milestones, budgets, data integrity, etc. Given the complex risk/benefit considerations associated with each specific clinical trial, there is no single solution to manage the risks in clinical trials conduct due to COVID-19. Each trial is unique with respect to patient population, study drug mechanism of action, concomitant medications, and geographic location needs. It is important to continue to engage the networks and communities to push forward with creative risk mitigation and develop solutions during this challenging time. Risk assessment should be a continuous and living process as the situation evolves over the coming weeks to months. Routine and ongoing cross checks with study teams are already proving to maintain alignment on key timelines, critical risk points and other study specific challenges as we are moving towards de-centralized settings in the conduct of clinical trials. We have analyzed lessons learned and attempted to develop best practices to mitigate risks and adjust clinical research operations during this unprecedented time.</p>