While it may seem like the whole world is on pause due to COVID-19, clinical trials in the U.S. can continue with adjustments to conditions or protocols while still adhering to regulations and ensuring patient safety. We explain recent FDA guidance in this post.
Amid the COVID-19 pandemic sweeping across the globe, clinical trials for drugs, medical devices, and biological products still need to press on for other diseases and medical conditions. To address potential concerns about how this should play out, on March 18, 2020, the FDA published Guidance for Industry, Investigators, and Institutional Review Boards: FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic.
The agency is issuing this guidance without prior public comment under section 701(h)(1)(C)(i) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2); however, it is currently open to public comment (Docket No. FDA 2020-D-1106).
Some of the issues that industry is facing include quarantines, site closures, travel limitations, and interruptions to investigational product supply chains. In addition, if site personnel or clinical trial participants become infected with SARS-CoV-2, the virus that causes COVID-19, trials could be put on hold or, even worse, canceled. Given these considerations, the FDA provided information about how to address protocol modifications or deviations. Specifically, the guidance focuses on the following:
- Assuring the safety of trial participants (see 45 CFR 46);
- Maintaining compliance with good clinical practice (GCP); and
- Minimizing risks to trial integrity (see the FDA’s Guidance for Industry: Data Integrity and Compliance with Drug CGMP – Questions and Answers).
With the FDA’s guidance, clinical trials conducted in the U.S. can continue with adjustments to conditions or protocols while still adhering to U.S. regulations and ensuring patient safety.
Trial participants should be kept informed about changes to any studies in which they are participating, the FDA noted. Since patient safety is the primary concern, sponsors should determine whether it is safer for patients to participate in safety assessments via phone, virtual visits, or an alternative location if COVID-19 is a concern and the process is acceptable for the trial. Investigators should modify trials according to the specific circumstances for those studies.
Sponsors should notify institutional review boards (IRBs)/independent ethics committees (IECs) as soon as possible about changes in protocol (for devices, see the FDA’s Final Guidance for Industry and CDRH Staff: Changes or Modifications During the Conduct of Clinical Investigation). If participants’ well-being or lives are in jeopardy, such changes may be implemented without IRB approval but must be reported afterward. Sponsors should consult with the appropriate review division to discuss efficacy assessments if there are protocol modifications, the FDA recommended.
In addition, delays may be appropriate, or sponsors may choose to halt recruitment or withdraw participants. Interestingly, the FDA is not requiring an amendment to trial protocols if COVID-19 screening is required by the healthcare system in which the trial is being conducted. That is, unless the sponsor plans to incorporate that data as part of a new research objective, the agency pointed out (see 21 CFR 312.30).
For clinical trials currently being established, the FDA recommends revising or creating policies and procedures to describe how participants will be protected during the pandemic and how trial conduct will be managed during possible disruption. This would include the impact on informed consent, study visits, data collection, study monitoring, adverse event reporting, and possible changes to staff due to COVID-19 illness.
All clinical trials impacted by COVID-19
The agency recommends that sponsors should describe the following in appropriate study report sections or in a separate document:
- Contingency measures implemented;
- A list of all participants affected by COVID-19–related study disruption and how their participation was affected; and
- Analyses of the impact of contingency measures on the safety and efficacy results reported.
While it may seem like the whole world is on pause due to COVID-19, cancer patients still need life-saving therapies, children with rare diseases still need a cure, and medical devices that sustain human life are more important than ever. With the FDA’s guidance, clinical trials conducted in the U.S. can continue with adjustments to conditions or protocols while still adhering to U.S. regulations and ensuring patient safety.
Continue checking our blog posts for additional updates and late-breaking news related to COVID-19. Cortellis Regulatory Intelligence users should set up alerts to receive updates on their desktop, or in the Cortellis Regulatory Intelligence mobile app.
Stay on top of the latest regulatory changes with Cortellis Regulatory Intelligence.