HTH RS M 732 / Adaptive Designs for Clinical Trials (Online)

3 unit(s)

Prerequisite(s): Must have completed HRM 702, 721, 730 or 733, or have permission of the instructor.

Randomized clinical trials are the gold standard for testing the effect of a novel intervention. Clinical trials can be expensive, time consuming, and can expose subjects to interventions that are potentially harmful and/or ineffective. Standard trial designs generally do not allow for modifications to key design components during the trial, but adaptive designs, on the other hand, allow for modifications to be made based on accumulative data or new knowledge that becomes available during the trial. With this adaptive learning nature, adaptive designs can improve the efficiency of the trial and reduce the risk of patients being exposed to harmful and/or ineffective interventions; however, they can be more challenging to design and execute. There are several operational and statistical challenges that must be addressed in order to preserve the integrity of the trial. In this distance education course, we will discuss the principles and
characteristics of adaptive designs, the advantages and disadvantages of conducting an adaptive clinical trial compared to a standard, fixed sample design, and potential operational and statistical challenges in adaptive designs.