Comparing Drug Benefit to Overall Harm Using a Concept of Demonstrated Insusceptibility to Treatment
Details
In larger randomized clinical trials, such as Phase III and Phase IV trials, data on adverse events is collected to determine if a purported benefit of a treatment outweighs the risk of the treatment in the intended population. However, a sample size is typically selected which is too small to rule out an increase in serious harms. Benefit is thus compared to harm using a hypothesis test for the beneficial outcome, versus an underpowered, sometimes informal assessment of possible treatment harm.
Learning Objectives:
- Explain how large randomized clinical trials (RCT) are currently failing in their purpose of determining if there is evidence for treatment benefit which outweighs evidence for possible harm
- Propose a method of analysis of demonstrated insusceptibility to treatment which might better serve this purpose
Colin Dormuth, ScD
Associate Professor
Faculty of Medicine – University of British Columbia
Dept of Anesthesiology, Pharmacology & Therapeutics
Co-Managing Director, Therapeutics Initiative
BC Lead, Canadian Network for Observational Drug Effect Studies (CNODES)
Dr. Colin Dormuth joined the Faculty of Medicine at the University of British Columbia in 2007. He is currently an Associate Professor in the Department of Anesthesiology, Pharmacology & Therapeutics, and Co-Director of the Therapeutics Initiative at UBC. Previously, he served as Chair for the Pharmacoepidemiology Group at the Therapeutics Initiative (2006 to 2019). Dr. Dormuth has also been co-principal investigator for the British Columbia site of the Canadian Network for Observational Drug Effect Studies (DSEN-CNODES) since 2011. Within CNODES, he has participated as the BC Site Liaison for multiple studies, served as Project Lead on the CNODES Training Team, and has been an active participant in the CNODES Methods Team. Dr. Dormuth has over 25 years of experience using administrative health care databases to evaluate drug safety, pharmaceutical policy changes and physician prescribing behaviour. He has training in epidemiology, economic theory, applied econometrics, health services outcome research, and biostatistics. Dr. Dormuth holds Sc.D. and S.M. degrees in epidemiology from Harvard University, an M.A. in economics from the University of Victoria, and a B.A. in economics from the University of Manitoba.