U.S. flag An official website of the United States government
  1. Home
  2. Science & Research
  3. Science and Research Special Topics
  4. Advancing Regulatory Science
  5. Ensuring Accuracy in Clinical Trial Publications: Weighing Options, University of Maryland CERSI -
  1. Advancing Regulatory Science


Event Title
Ensuring Accuracy in Clinical Trial Publications: Weighing Options, University of Maryland CERSI

Wednesday, March 22, 2017

Presented by:

Picture of Peter Doshi, PhD

Peter Doshi, PhD
Associate Editor, The BMJ
Assistant Professor
Pharmaceutical Health Services Research
University of Maryland School of Pharmacy

About the Presentation

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 In numerous cases, data from unpublished and misreported trials has vastly changed our understanding of the safety and efficacy of specific drugs. FDA 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 healthcare 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. In this talk, Dr. Doshi discussed the various ways academics, journals, and FDA scientists can help fix these intractable problems with the medical literature.

Since Dr. Doshi’s lecture, he and a colleague have published an editorial on this topic in The BMJ:
PDoshi and FGodlee, The wider role of regulatory scientists, The BMJ, April 27, 2017,
http://www.bmj.com/content/357/bmj.j1991.full?ijkey=BpVIzvF15k4WHLc&keytype=ref disclaimer icon

About the Presenter

Peter Doshi is an assistant professor of Pharmaceutical Health Services Research at the University of Maryland School of Pharmacy and associate editor at 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. Dr. Doshi also has strong interests in journalism as a vehicle for encouraging better practice and improving the research enterprise. Since 2009, Dr. Doshi 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 Ph.D. in history, anthropology, and science, technology and society from the Massachusetts Institute of Technology.

Back to Top