Risk and Mitigation Actions for Clinical Trials During COVID-19 Pandemic (RiMiCOPa)

COVID-19 continues to affect clinical trials, both directly and indirectly, across the world.  Each step, from protocol design to results disclosure, needs to be revised to assess COVID-19 impact, evaluate the potential risks, and establish a mitigation plan. In November 2020, the National Center for Biotechnology Information published our recommendations, “Risk and mitigation actions for clinical trials during COVID-19 pandemic (RiMiCOPa),” written by Alira Health’s Antonella Bacchieri, Senior Consultant Statistician, and Paolo Morelli, Executive Vice President, Biometrics, in collaboration with Andrea Rossi, Consultant in Medical Writing, Communications and Scientific Affairs. 

The RiMiCOPa document, based on EMA and FDA guidelines, provides advice on evaluating how the different aspects of clinical trials should be handled to mitigate the impact of the COVID-19 pandemic on data management, statistics, and medical writing activities, maintaining the required quality standards.