By Thomas Laage, M.D., MPH, Director, Product Development Consulting and Regulatory Medical Writing Support
Adaptive design is a type of clinical trial methodology that incorporates prospectively planned opportunities for modification of one or more aspects of a study’s design or its hypotheses based on interim analysis of study data. Explicitly planning these pre-specified changes helps to maintain scientific integrity while also introducing greater flexibility in the clinical research environment. The major objectives of adaptive design are to make trials more efficient, informative, and likely to demonstrate significant clinical effects in investigational products. And such innovations are necessary in today’s clinical research climate where high attrition rates, lengthy research and development programs, and skyrocketing costs are common.
So far, adaptive design strategies have been especially useful for rare disease research in general and rare oncology in particular. Read more to see how the savvy application of adaptive trial design compares to conventional study designs.