Penn Bioethics Seminar Series (PBS): Jonathan Kimmelman, PhD. "Phase 2 Bypass/Override: A Study in the Moral Efficiency of Drug Development"

Phase 2 Bypass/Override: A Study in the Moral Efficiency of Drug Development
 

Jonathan Kimmelman, PhD

Director of Biomedical Ethics Unit
Department of Equity, Ethics and Policy
McGill University | Quebec, Canada

Conventional drug development involves three phases of clinical testing, with phase 2 trials representing a bridge between preclinical and safety testing and confirmation of efficacy in phase 3 trials. However, many drug developers either skip phase 2 testing ("phase 2 bypass") or they advance drugs to phase 3 trials despite negative phase 2 trial results ("phase 2 override"). In this talk, I will present findings from studies assessing the prevalence of phase 2 bypass/override in cancer and neurology, and its implications for risk/benefit in phase 3 trials. I will further unpack the ethics of phase 2 bypass/override, and suggest that, far from an esoteric challenge in research ethics, bypass/override offers a window into a broad set of ethical questions concerning the relationship between evidence and research decision-making.

Jonathan Kimmelman is a James McGill Professor in the Biomedical Ethics Unit / Social Studies of Medicine. He has cross appointments in Experimental Medicine, Epidemiology, Biostatistics and Occupational Health, and Human Genetics. Kimmelman holds a PhD in Molecular Biophysics and Biochemistry from Yale University, and joined McGill in 2005. His research revolves around the ethical, social and policy dimensions of translational research. He received the Institute of Genetics Maud Menten New Investigator Prize, a CIHR New Investigator Award (2008) and a Friedrich Bessel- Humboldt Award (2014). Kimmelman chaired the ethics committee of the American Society of Gene and Cell Therapy, 2008-2010, and chairs the ethics committee of the International Society of Stem Cell Research. 
 

Lunch provided.
Streaming available via Zoom.