FDA Updates Guidance with an Appendix Adding Questions and Answers on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

FDA Updates Guidance with an Appendix Adding Questions and Answers on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

The U.S. Food and Drug Administration issued an updated guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding questions and answers on this subject. We plan to update this appendix as new questions arise. This guidance is intended for industry, investigators and institutional review boards.

The FDA issued this guidance because we recognize that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products. For example, challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19. These challenges may lead to difficulties in conducting the clinical trials.

The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19. Although the impact of COVID-19 on trials will vary depending on factors such as the nature of disease under study, the trial design, and in what region(s) the study is being conducted, FDA’s guidance outlines general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity. The new appendix further explains those considerations by responding to related questions the agency has received. 

Issues addressed in the questions and answers include submitting protocol amendments, documenting protocol deviations, initiating virtual clinical trial visits for monitoring patients, making changes to ship investigational products directly to patients, and obtaining and documenting informed consent from patients in isolation due to COVID-19.