Drugs

Clinical Trial Modernization and Innovation Meeting

David McFarland

— 1 min read
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An FDA summary of its 10/18-10/19/2023 virtual public meeting on “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies,” calls for maintaining momentum started under the Covid-19 public health emergency to embrace modernization and continue innovations in clinical research. The meeting and publication of the summary were mandated by the FDA Omnibus Reform Act of 2022.

Several meeting panelists cited FDA’s 9/2023 guidance on considerations for conducting clinical trials of medical products during major disruptions due to disasters and public health emergencies “as a step forward in leveraging lessons learned from the Covid-19 public health emergency,” the report says. “The guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct and operations due to disasters or public health emergencies….”

The panelists said it was important to maintain momentum because disruptions can occur at any time during the conduct of clinical studies and can happen for many different reasons.

The summary emphasizes these topics:

  • the actions sponsors took to use FDA Covid-19 recommendations and the frequency at which the recommendations were used;
  • the characteristics of the sponsors, studies, and patient populations affected by the recommendations;
  • a consideration of how the recommendations may have affected access to clinical studies for certain patient populations; and
  • recommendations to incorporate certain clinical study disruption mitigation recommendations into current or additional guidance to improve clinical study access and enrollment of diverse patient populations.

FDA concludes that it “looks forward to continuing engagements and mutual learnings across the clinical research ecosystem to facilitate adoption and implementation of best practices that will ensure timely access to safe and effective medical products and enhance public health through resilient and agile clinical studies. It will be the collective responsibility of the clinical trial community to apply the lessons learned from the Covid-19 public health emergency to modernize future clinical studies.”

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