REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot101710.21518/1561-5936-2020-11-12-18-24Original ArticleClinical trials in the Coronavirus era: management of risksVodovozovAlekseynoemail@neicon.ruRemedium1112202011-12182418032022Copyright © 2020,2020The 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.EMAFDACOVID-19clinical trialsEMAFDArecommendationsCOVID-19risk managementклинические исследованиярекомендацииуправление рисками1.COVID-19 and Clinical Trials: The Medidata Perspective. Release 7.0. Medidata Solutions, Inc., a Dassault Systèmes company, 2020., pp. 1-18.2.Home - ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ ct2/home (дата обращения 10.12.2020).3.Clinical Trials Register. Available at: https://www. clinicaltrialsregister.eu/ctr-search/search (дата обращения: 10.12.2020).4.European Medicines Agency. International regulators provide guiding principles for COVID-19 clinical trials. Available at: https:// www.ema.europa.eu/en/documents/press-release/international- regulators-provide-guiding-principles-covid-19-clinical-trials_ en.pdf (дата обращения: 10.12.2020).5.FDA Drug and Device Resources. ClinicalTrials.gov - clinical trial conduct during the COVID-19 pandemic. Available at: https://www. fda.gov/drugs/coronavirus-covid-19-drugs/clinical-trial-conduct- during-covid-19-pandemic (дата обращения: 10.12.2020).6.Michaels M.G., La Hoz R.M., Danziger-Isakov L., Blumberg E.A., Kumar D., Green M. et al. Coronavirus disease 2019: implications of emerging infections for transplantation. Am J Transplant. 2020;20(7):1768-1772. doi: 10.1111/ajt.15832.7.Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials, European Medicines Agency. Available at: https://www.ema.europa.eu/ en/implications-coronavirus-disease-covid-19-methodological- aspects-ongoing-clinical-trials (дата обращения: 10.12.2020).8.FDA Guidance for Industry. Statistical considerations for clinical trials during the COVID-19 public health emergency. Available at: https://www.fda.gov/media/139145/download (дата обращения: 10.12.2020).9.European Medicines Agency. ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials - Step 2b (2017).10.Meyer R.D., Ratitch B., Wolbers M., Marchenko O., Quan H., Li D., et al. Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic. Statistics in Biopharmaceutical Research. 2020;12(4):399-411. doi: 10.1080/19466315.2020.1779122.11.Battisti W.P., Wager E., Baltzer L., Bridges D., Cairns A., Carswell C.I. et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461-464.12.Mitchell E.J., Ahmed K., Breeman S. et al. It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials. 2020;21:784. doi: 10.1186/s13063-020-04711-6.