Many drug companies have already put in place trials that use some type of adaptive designs. But most times, companies implement adaptive trial design experimentally, mitigating risk by applying it only during early-phase trials, according to Cutting Edge Information.
An adaptive clinical study is one that includes a prospectively planned opportunity to modify one or more specified aspects of the study design and hypothesis based on an analysis of data, usually at the interim period, according to the FDA’s draft guidance for adaptive…
Primary Obstacles to Using Adaptive Designs
Adaptive Design Trends