Free Webinar: Ensuring Accuracy in Clinical Trial Publications: What Can We Do About It
When the completeness or accuracy of the medical literature - particularly publications of clinical trials - is in doubt, so too are standards of care, clinical practice guidelines, and systematic reviews. In numerous cases, data from unpublished and misreported trials has vastly changed our understanding of the safety and efficacy of specific drugs. Regulatory scientists have unique insights into this problem and unique abilities to do something about it, in doing so both improving clinical care and promoting more prudent use of health care resources. In the case of neuraminidase inhibitors, the United States spent over $1 billion stockpiling the drugs; however, FDA approved labeling indicates the drug only has modest effects on symptoms. This webinar will discuss the various ways academics, journals, and regulatory scientists can help fix these intractable problems with the medical literature.
About the Presenter:
Peter Doshi, PhD, is an assistant professor in the Department of Pharmaceutical Health Services Research (PHSR) at the School of Pharmacy and associate editor for The BMJ. His research focuses on policies related to drug safety and effectiveness evaluation in the context of regulation and evidence synthesis. He is an advocate for greater public access to clinical trial data, and maintains a strong interest in journalism as a vehicle for encouraging better practice and improving the research enterprise. Since 2009, he has worked with a team that sifted through FDA approval packages and formerly confidential clinical study reports of the anti-influenza drugs oseltamivir and zanamivir. He completed a post-doctoral fellowship in comparative effectiveness research at Johns Hopkins University and received his doctorate in history, anthropology, and science, technology and society from the Massachusetts Institute of Technology.
Published March 31, 2017