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Food and Drug Administration and Compliance Issues
Thursday, April 16, 2020
FDA Updates Question-and-Answer Appendix in Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
The updated guidance includes new content on conducting remote clinician-reported outcome or performance outcome assessments; remote site monitoring; electronic common technical document requirements (https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd); investigational product administration by a local health care provider who is not a sub-investigator; and information for sponsors on who they should contact at the FDA regarding certain changes to ongoing trials. There is also updated information about obtaining informed consent from a patient who is unable to travel to the clinical trial site due to COVID-19 illness or travel restrictions in situations where electronic informed consent is not an option.
The 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 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 appendix further explains those considerations by responding to related questions the agency has received.