Grant: Banting Postdoctoral Fellowship Program

In recent years, there has been a growing concern about the proper conduct and monitoring of clinical trials. High on the agenda of clinical researchers and health policy makers is the inadequate reporting on clinical trials. Regulatory agencies such as Health Canada and the U.S. FDA have issued recommendations and guidance for both the conduct and reporting of clinical trials. Despite these efforts, recent reviews of clinical trials indicate that there are a growing number of clinical trials stopping early, and that top medical journals continue to publish the results of such trials without reporting sufficient details for readers to evaluate early stopping decisions carefully. In my research I introduce a decision framework that allows for a systematic way of modeling and simulating early stop decisions of clinical trials. I propose a computer software implementation of the framework. The computer software implementation of the framework will not only model early stop decisions but allow users (readers and skeptic reviewers of clinical trials) to generate 'what-if' questions by simulating alternative trial scenarios. By simulating and comparing alternate scenarios, the software enables users both to better understand a trial's conduct and to be in a better position to assess the legitimacy of its results. The modeling of decisions and their assessments shall help articulate clear and general principles guiding decisions in clinical trials; articulations that in turn permit for the public accountability of such decisions. Because the decision framework permits combining contextual factors commonly appealed to by researchers during the conduct of their trials, the computer software implementation of the framework shall also assist researchers with handling ethical conflicts that might arise during the monitoring of hard-case clinical trials.