Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Type: Consensus Study
Topics: Quality and Patient Safety, Biomedical and Health Research
Board: Board on Population Health and Public Health Practice

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Activity Description

The Food and Drug Administration has requested that the IOM convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs.

Questions to be explored by a committee include:

  1. What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?
  2. What are the strengths and weaknesses of various approaches, including observational studies, including patient registries, meta-analyses, including patient-level data meta-analyses, and randomized controlled trials, to generate evidence about safety questions?
  3. Considering the speed, cost, and value of studies, what types of follow-up studies are appropriate to investigate different kinds of signals (detected pre-approval or post-marketing) and in what temporal order?
  4. Under what circumstances should head-to-head randomized clinical trials for safety be required?
  5. How should FDA factor in different kinds of safety evidence in considering different kinds of regulatory actions?

Learn more about and comment on committee members.

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