IHR Seminar: Modelling of pharmaceuticals licensed without RCT data

Pharmaceuticals are most commonly licensed in randomised controlled trials against placebo or active comparators. On occasion however, drugs are approved without a comparative trial being available. This talk will discuss the circumstances and ethics around such approvals, and present work on the number of treatments licensed over the past 15 years under such circumstances, and how their comparative efficacy has been modelled. Following this, there will be a discussion of other techniques that can be used and ongoing work to estimate efficacy based on historical controls and other methods, including propensity scoring, matching adjusted indirect comparisons, and novel techniques.

Anthony Hatswell is a Principal Consultant at BresMed where he works as a health economist on NICE submissions, evidence generation, and quality of life analysis. His PhD is part time as a mature student on the estimation of comparative effectiveness from uncontrolled clinical studies. Prior to BresMed, he graduated from the University of York, before holding roles at and sanofi-aventis and GSK UK.