COVID-19 Client Resources and Updates

On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a Guidance Document for sponsors, investigators and institutional review boards (IRBs) conducting clinical trials during the coronavirus (COVID-19) pandemic.

The purpose of this Alert is to summarize the Guidance Document, which identifies potential challenges and outlines considerations to push ongoing clinical trials forward, without compromising good clinical practice, trial integrity and safety of trial participants.

Challenge

The FDA acknowledges that “quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations” may arise in connection with ongoing clinical trials. While the impact will vary on a case by case basis, these challenges will surely lead sponsors and investigators to practice alternative study processes, which in turn will result in protocol modifications and protocol deviations.

Considerations

Alternative Study Processes

Following are some of the study processes (not exhaustive) that the FDA encourages sponsors to consider to assure the safety of trial participants, compliance with good clinical practice and trial integrity:

• Alternative methods to in-person safety assessments, such as phone contact, virtual visits, alternative locations for assessment including local labs or imaging centers.
• Additional safety monitoring for those trial participants who may no longer have access to the investigational product or the investigation site.
• Alternative methods to scheduled visits for investigation product delivery, such as home nursing or alternative sites by trained non-study personnel.
• Alternatives to efficacy assessments, such as virtual assessments, delays in assessments and alternative collection of research-specific specimens, if feasible.
• Alternatives to on-site monitoring visits, such as central and remote monitoring programs to maintain oversight of clinical sites.

Documentation

Considering that alternative study processes will result in protocol modifications and deviations, the FDA emphasizes the importance of good documentation practices to minimize risk of trial integrity. For example, protocol changes may require capture of specific information in the case report form that explains the basis for missing data (such as missed visits) due to COVID-19. Good documentation practices should carry through to the clinical study report, where the FDA recommends sponsors describe (1) contingency measures implemented as a result of COVID-19, (2) a listing of trial participants affected by COVID-19 and how their participation was altered and (3) analyses and corresponding discussions addressing the impact of implemented contingency measures.

Trial Participant Safety and Informed Consent

While these alternative study processes are recommended to move ongoing clinical trials forward, the FDA urges sponsors to practice these alternatives on a case by case basis, focusing primarily on the safety of each trial participant. To ensure trial participant safety, sponsors should consult with investigators, IRBs and FDA review divisions when making certain modifications to the study and protocol. Additionally, sponsors and investigators should ensure trial participants are informed of any changes to the study that could impact their safety, welfare and rights.

Visit Wiggin and Dana’s COVID-19 Resource Center here for additional publications and helpful links on multi-disciplinary topics that are relevant during the current COVID-19 global pandemic.