Making the Case for Early Phase Trials: The PATH Approach

Advancing novel treatment hypotheses into clinical development is costly and entails risk and burden for research volunteers. Evidence supporting the clinical hypothesis is key to justifying this expense and burden. Yet in many cases, early phase trials are initiated despite weak or equivocal supporting evidence. It’s unclear how closely oversight bodies attend to the strength of supporting evidence when reviewing early phase trials.

This lecture, provided by Dr. Jonathan Kimmelman of McGill University, will provide an overview of an approach, Preclinical Assessment for Translation to Humans (PATH), for organizing and presenting evidence supporting early-phase trials. The approach aims to be more systematic, transparent, and accurate than existing approaches used in grant applications or trial protocols. PATH aims to integrate different types of mechanistic evidence supporting a trial, highlight the extent to which supporting studies address validity threats, and elicit assumptions about the translatability of findings from model systems.

Join online: https://westernuniversity.zoom.us/j/93103343188