Introduction to Adaptive Design Clinical Trials for Drugs and Biologics

Adaptive Design Clinical Trials

An adaptive design is defined as a clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. The modifications may include the eligibility criteria, study dose, treatment duration, study endpoints, laboratory testing procedures, diagnostic procedures, criteria for evaluation, and assessment of clinical responses. Statistical procedures include randomization, study design, study hypotheses, sample size, data monitoring, and interim analysis, statistical analysis plan, and/or methods for data analysis.