February 2015 marks the five year anniversary of the FDA’s Guidance on Adaptive Design Clinical Trials for Drug and Biologics, as well as the FDA’s Guidance on the Use of Bayesian Statistics in Medical Device Clinical Trials. In honor of the five year anniversary of both sets of guidance, the DIA will hold a special joint conference between its Adaptive Design working group and its working group on Bayesian Statistics.
Zoran Antonijevic is Senior Director at Cytel Consulting and the Head of the DIA Working Group on Adaptive Design. In this interview Zoran explains the main objectives of the two working groups, and reviews some of the work they completed last year. According to Zoran, adaptive design is an important framework for developing flexible trial designs, a flexibility that is of interest to Bayesian statisticians in the development of decision rules for clinical trials.
Adaptive designs have redefined the role that statisticians can play in clinical development and trial planning. In this interview, Zoran explains the importance of bringing knowledgeable statisticians into the board room, improving the ability of a statistician to make risk assessments through adaptive design, and the general impact of the adaptive framework on drug development.
Related Items of Interest
FDA’s Guidance on Adaptive Design Clinical Trials for Drug and Biologics
FDA's Guidance on the Use of Bayesian Statistics in Medical Device Clinical Trials
Clinical Drug Development: Predictions & Trends for 2015
Operationally Seamless & Inferentially Seamless Adaptive Designs
5 Scenarios When ‘Keep it Simple’ May Be Bad Advice for Clinical Trial Designers
Adaptive Clinical Trials: Your Questions Answered
