Eric M. Meslin, Ph.D., Director of the IU Center for Bioethics and Associate Dean for Bioethics IUSM, has been appointed to the Institute of Medicine’s Committee on Drug Safety and Post-Marketing Requirements by IOM President Harvey Feinberg. The Committee has been asked by the FDA to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs. Questions to be explored by the 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?
The Committee is charged with reporting its findings in March 2011. Complete information including the IOM Committee roster is available at: http://www.iom.edu/Activities/Quality/DrugSafetyPostMarket.aspx