Our ICON Insights will help you understand and successfully address the complexities of adaptive trial design and execution.
High attrition rate in phase III trials, lengthy development programs, and increasing development costs all demand a smarter approach to drug and medical device development. Adaptive design, identified in FDA's critical path initiative as one way to improve trial efficiency, can add value to all phases of development. In exploratory phases of drug development, adaptive design can combine development phases and improve resource allocation. In confirmatory trials, they enable early stopping, change of allocation rates, and reassessment of the sample size, patient subgroups or specific treatment arms. With better data and improved decision making, adaptive designs can increase the probability of success and decrease development time.
In 2013, the Tufts Center for the Study of Drug Development (CSDD), published a R&D Executive Management Brief on ‘The Adoption and Impact of Adaptive Trial Designs’. The report details the output from an executive roundtable attended by senior executives from over 20 companies, including 11 of the top 15 pharmaceutical companies, as well as representatives from the FDA and EMA. The report indicates that adaptive design has a critical role to play in delivering increased product development efficiency and productivity. It calls on Industry executives to unite to drive wider adoption. Although the discussants were primarily from the pharma, the findings are relevant to early stage biotechnology companies as well as companies developing diagnostics and medical devices.