FDA Suggests Assessment Committees for Safety Reporting

The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded.

In draft guidance released last month, the FDA provides suggestions on how to organize safety assessment committees and considerations for when safety data should be unblinded.

Specifically, the guidance spells out recommendations on:

  • The composition and role of a safety assessment committee;
  • Aggregate analyses for comparing adverse events across treatment groups;
  • Planned unblinding of safety data;
  • Reporting thresholds for IND safety reporting; and
  • Development of a safety reporting plan.

Sponsors should create a surveillance plan to be submitted with their INDs that offers specific plans for the makeup of safety committees, including responsibilities and policies, especially on unblinding safety data. These policies need to be available during FDA inspections, the agency says.  

The safety assessment body would be in charge of pooling research from across multiple studies to look for patterns of critical side effects, the guidance says. Reviews should be done regularly and, when necessary, be evaluated for specific safety signals.

The committee also would be responsible for recommending whether adverse events require an IND safety report.  Reviewers would assess the need for revising informed consent forms and investigator brochures if concerns arise.  

The safety assessment should be unblinded to better characterize the nature of the risk, the FDA recommends. To protect the process, only the information necessary should be unblinded — no endpoints or efficacy — and protocols should be in place to make sure the data does not accidentally fall into the wrong hands.

Interested parties may comment on the draft document through Feb. 17. Read the guidance at www.fdanews.com/12-16-15-IND-Safety-Guidance.pdf. — Victoria Pelham


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