Risk and mitigation actions for clinical trials during COVID-19 pandemic (RiMiCOPa)

The COVID-19 virus diffusion is, nowadays, global and any clinical trial is potentially affected by the direct and indirect consequences of the COVID-19 during the pandemic. Any step, from protocol design to result's disclosure, needs to be revised to assess the impact of the COVID-19 on the study, evaluate the potential risks, and establish a mitigation plan. We have developed a series of recommendations, belonging to our experience in any aspect of clinical trials. We hope that the Risk and Mitigation actions for clinical trials during COVID-19 Pandemic (RiMiCOPa) will help all clinical trial professionals, patients, auditors, and assessors to ensure effective data management, statistics, and medical writing standards while conducting clinical trials in the pandemic.