The COVID-19 pandemic has caused unique problems facing the clinical trials (CT) community both in terms of the rapid implementation of CTs of COVID-19 drugs and vaccines, and many ongoing non-COVID-19 CTs that are either suspended or adapted to new realities. The CT organizers have played a key role in decision making, risk assessment and adaptation of trial processes, working side by side with other members of the trial team. Regulatory authorities (FDA, EMA, Ministry of Health of Russia, etc.), which issued initial recommendations for adapting the clinical trial methodology to new conditions as far back as March 2020, and then later on, generalized the experience in the management for clinical trials. The recommendations made based on the reviewed experience can help all CT parties to cope with the risks associated with both COVID-19 itself and anti-epidemic measures in different countries of the world with minimal losses.
Clinical Trial Team Member Curriculum Vitae
