Research Ethics and Policy Series (REPS): Jonathan Kimmelman, PhD. "Assessing the Scientific Case for Early Phase Trials and/or Innovative Care: the PATH Approach"

Assessing the Scientific Case for Early Phase Trials and/or Innovative Care: the PATH Approach
 

Jonathan Kimmelman, PhD

Director of Biomedical Ethics unit
mc gill university
quebec, canada

Early phase trials and innovative care protocols draw their support from basic science, preclinical studies and clinical research. Because these forms of evidence vary and address different questions, methods for synthesizing evidence and assessing scientific and ethical merit, like meta-analysis, are inapt.  In what follows, I offer a structured approach, PATH (Preclinical Assessment of Translation to Humans) for presenting a comprehensive, accurate and transparent scientific justification for early phase trials and innovative care. PATH is grounded on the premise that the case for administering novel strategies to patients requires connecting the dots between nine mechanistic steps supporting a clinical hypothesis. The task for using PATH entails first parsing supporting evidence into the nine mechanistic steps, assessing the strength of evidence at each step, and then assessing the strength of a chain of evidence linking drug administration to clinical effect. Further applications of PATH, including its potential use in health technology assessment, research planning and risk assessment will be discussed briefly.

Jonathan Kimmelman is a James McGill Professor in the Biomedical Ethics Unit/Social Studies of Medicine at McGill University, Montreal, QC. He has cross appointments in Experimental Medicine, Epidemiology, Biostatistics and Occupational Health, and Human Genetics.

Lunch provided.
Streaming available via Zoom