FDA Updates Question-and-Answer Appendix in Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency
The U.S. Food and Drug Administration added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators, and institutional review boards.
The updated guidance includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol.
FDA issued this guidance because we recognize that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products, including drugs, devices, and biological products. For example, challenges may arise from isolation practices, 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.
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 appendix further explains those considerations by responding to related questions the agency has received.