Clinical trials during the COVID-19 pandemic: research design and lessons

Abstract

The COVID-19 pandemic has required a substantial coordinated international effort to develop effective treatments and vaccines, which has led to an acceleration in innovation in clinical research with the rapid adoption of pragmatic, open, adaptive platform trials for new therapeutics. Large platform trials such as RECOVERY, SOLIDARITY and REMAP-CAP have demonstrated the ability to recruit thousands of patients across multiple sites in a short period of time, resulting in therapies that have now been adopted into clinical practice. Therapies tested for COVID-19 include repurposed antivirals, immunomodulatory drugs, convalescent plasma and, more recently, novel therapeutics developed specifically to target SARS-CoV-2. Challenges have included ethical and practical issues of delivering clinical research during a pandemic, some duplication of effort and the testing of some therapies with a low likelihood of success. COVID-19 has required acceleration of the process of clinical trial conduct, from grant funding to approvals and simplification of trial processes. Many of the innovations and simplifications to clinical trial conduct that have featured so prominently during the COVID-19 pandemic are likely to be just as valuable in a post-pandemic world. An important legacy of the pandemic may be a more efficient and effective way of delivering clinical research in the future.Copyright © ERS 2021.