Senior Scientist Tom Cook and Associate Scientist Kevin Buhr, in collaboration with University of Utah Associate Professor Charlie Casper presented an evening workshop titled “Conducting Valid Trials: The Critical (and Misunderstood) Roles of Randomization and Complete Follow-Up” at the Society for Clinical Trials 36th Annual Meeting in Arlington, Virginia.
Randomized, double-blind clinical trials are widely considered the gold standard for establishing causal relationships between interventions and outcomes of interest. However, the importance of randomization and the intention-to-treat (ITT) principle in the design, conduct, and analysis of such trials — while widely recognized — is often not well understood. In this first-time SCT workshop, Cook and colleagues used easily understood models and examples, accessible to a non-mathematical audience, to demonstrate why randomization and ITT analysis lead directly to valid assessments of whether a new treatment “works”.
Despite some initial skepticism on the part of the Society's Education Committee, the workshop was very well received and sported the second highest attendance at the meeting. The presenters are planning to extend it to a longer morning workshop for next year's meeting.
The Society for Clinical Trials is an international professional organization dedicated to the development and dissemination of knowledge about the best practice in design, conduct, analysis and reporting of clinical trials with membership from government, academia, industry and non-profit organizations.