FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
Guidance for Industry, Investigators, and Institutional Review Boards
In March 2020, the FDA issued a guidance to assist sponsors in evaluating the effects of the COVID-19 public health emergency on the safety and conduct of their clinical trials. On April 16, 2020, the FDA provided an update to the guidance in the form of an appendix, which includes answers to questions received by the Agency.
General considerations for sponsors as outlined in the guidance include:
- The safety of trial participants is of utmost importance in determining if changes in trial conduct are required.
- Sponsors should consult with clinical investigators and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), if appropriate, to determine if a participant should continue in a trial, if changes to a protocol are warranted as a result of COVID-19, and to implement or revise policies and procedures to describe the management of study conduct if there are disruptions in the trial due to COVID-19.
- Trial logistics including the evaluation of alternative methods for safety assessments and monitoring, delaying enrollment, administration and availability of investigational products, and COVID-19 screening procedures that may be mandated should be considered.
- Documentation of changes in study conduct, duration of those changes, listing the impacted trial participants and how they were impacted is important.
- Sponsors should consider consulting with the applicable FDA review division for trial conduct changes including changes to the protocol that lead to amending data management and/or statistical analysis plans.
This is a brief summary of the Guidance provided by the FDA and is not reflective of the full content of the Guidance. The full Guidance, with Appendix can be referenced here: https://www.fda.gov/media/136238/download
It should be noted that the policy is to remain in effect only for the duration of the public health emergency. However, we should evaluate these considerations, as well as our experiences throughout the pandemic, to improve and shape the future of clinical trial design and management. PharmaLex supports clients with review and input into safety section of protocols, developing safety management plans and preparing aggregate reports that may require additional documentation of exceptions and modifications made due to COVID-19. PharmaLex is experienced in establishing and facilitating the network of sponsor, investigator and CRO to ensure accurate safety monitoring and reporting.