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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting, May 21, 2009

Public Summary

The Executive Director updated the Board on risk communications [Public Health Advisories (PHAs), Early Communications about Ongoing Safety Reviews (ECs), and Information for Healthcare Professionals (HCP)] posted and in development since the April 16, 2009 meeting. The following is a list of the posted risk communications:

  1. April 21, 2009 - Ceftriaxone and Calcium-Containing Products
  2. May 1, 2009 - Follow-up to the February 8, 2008, Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
  3. May 5, 2009 - Suicidal Behavior and Ideation and Antiepileptic Drugs

The Drug Safety Oversight Board (DSB) discussed the role of meta-analyses in FDA's reviews of drug safety.

The DSB invited Dr. Rebecca DerSimonian to serve as the Board’s guest expert on meta-analysis. Dr. DerSimonian is a mathematical statistician for the Division of AIDS at the National Institute of Allergy and Infectious Disease, National Institutes of Health. She has participated in protocol reviews of clinical trials sponsored by the Division of AIDS and serves as the Executive Secretary of the HIV Therapeutic Trials Data and Safety Monitoring Board. Important methodological contributions resulting from her research include improving standards for reporting of clinical trials, meta-analysis, missing data, case-based studies and tests of heterogeneity. She has over 30 publications from her research and has published 3 book chapters.

A meta-analysis is an analysis performed from combining the results of several studies that address a set of related research questions. The Board specifically addressed meta-analysis performed by academia and other health care organizations where the results identified a new drug safety issue not addressed in the full prescribing information for the drug product. The Board discussed how FDA should best understand and incorporate the abundance of research publications using meta-analyses into its decision-making processes involving drugs.

Some of the issues highlighted by the Board regarding meta-analyses are:

  • Reconciling publications employing meta-analyses with data from clinical trials conducted by the sponsor
  • How to address missing and heterogeneous data
  • How to use meta-analytical methods when dealing with studies reporting low adverse event rates
  • How to deal with wide variation in the amount and form or quality of the data available
  • The challenges when assessing studies containing indirect comparisons, and combining data from short-term and long-term studies
  • How to weigh data from a meta-analysis using individual patient data against data from a meta-analysis based on summary statistics