FDA Outlines Trial Disruption Steps Due to Covid-19

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18 Mar. 2020. The Food and Drug Administration outlined steps clinical trial teams should take if their studies face disruptions from the novel coronavirus, or Covid-19, pandemic. The agency issued its guidance document today, as several companies reported disruptions in clinical trials as a result of the emergency.

Many state and local governments in the U.S. are responding to the pandemic with emergency declarations closing businesses, schools, and colleges, including universities with research labs. Other jurisdictions are limiting travel by residents, with the most severe restrictions in the San Francisco Bay area, home to many biotechnology companies. In addition, the tri-state region of New York, New Jersey, and Connecticut recommends an 8:00 pm to 5:00 am curfew.

These quarantines, site closures, and travel restrictions, says FDA, are likely to make it difficult for many trial participants and study team members to keep appointments, as well as prevent needed supplies from reaching trial sites. The agency’s document says study teams and review boards should put the highest priority on maintaining the safety of trial participants, and guide decisions accordingly on further enrollment, use of products being tested, and monitoring of patients.

Travel restrictions may also require study teams to use virtual meetings or telemedicine to collect data, rather than in-person visits. And in cases where participants no longer have access to an experimental drug or device, additional safety monitoring may be needed. Where extended delays are anticipated, study teams will need to decide if the study can continue under existing protocols, keep enrolling new participants, or withdraw some participants who can no longer be supported.

Because of these anticipated disruptions, study teams are encouraged to document all changes in enrollment and protocol, and indicate data missing from their findings due to Covid-19. In cases where Covid-19 screenings are required by local authorities, study teams do not need to report these tests, unless the results may affect trial outcomes.

All clinical trials possibly affected by the pandemic are asked by FDA to prepare contingency plans to manage their studies if disrupted by Covid-19 restrictions. Study teams are also asked to list participants affected by the pandemic by their assigned identifiers and describe how their participation is altered. In addition, study teams need to discuss the impact of contingency measures on trial findings, such as participant discontinuations and alternative data collection methods.

“The FDA released this guidance,” says Anand Shah, deputy commissioner for medical and scientific affairs in an agency statement, “to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.”

The industry newsletter Biopharma Dive reports that so far this week four biotechnology companies — Provention Bio, Addex Therapeutics, Arrowhead Pharmaceuticals, and Iveric Bio — disclosed delays to their clinical trials. Also, on Monday, National Institutes of Health issued guidance to its grant recipients on conducting clinical trials during the Covid-19 pandemic.

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