The Justification of Statistical Decisions in Clinical Trials (R. Stanev)

Conférence | Talk

Roger Stanev

(Ottawa Hospital Research Institute and University of Ottawa Faculty of Medecine)

The Justification of Statistical Decisions in Clinical Trials

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 is the inadequate reporting of randomized controlled trials (RCTs), including trials that are stopped early due to benefit, harm or futility. Despite efforts from regulatory agencies (e.g., Health Canada) issuing recommendations and guidance for both the conduct and reporting of RCTs, recent systematic reviews of RCTs show that top medical journals continue to publish trials without requiring authors to report sufficient details for readers to evaluate statistical decisions carefully.

In my talk, I present a systematic way of modeling and simulating interim decisions of RCTs. By taking an approach that is both general and rigorous, my proposal models and evaluates early stopping decisions of RCTs based on a clear and consistent set of criteria. The framework permits decision analysts to generate and answer 'what-if' questions by simulating alternate trial scenarios. I illustrate the framework with a case study of an RCT that was stopped early due to futility. This was a trial evaluating an intervention to prevent a brain-infection in HIV+ symptomatic individuals. 

Friday, November 28th, 2014

3:00pm

University of Ottawa

Desmarais Hall (55, Laurier East)

Room 8161