Why Adaptive Trial Designs Require Adaptable Technology

In The Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry, the FDA defines adaptive clinical trial designs 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 adaptive trial approach has been reported to reduce potential costs by creating greater upfront flexibility and comparing more treatments, providing insights for earlier decisions. High failure rates and increasing costs have driven the industry toward adaptive trial designs recently, among the design’s attractive benefits. By operating under an adaptive trial design, researchers can determine whether to stop the trial earlier, drop treatments or dosage early and test more treatments simultaneously. At the same time, patients are more likely to participate and stay engaged when they believe there is a greater probability of getting the best treatment.

While the study design is growing more popular for its ability to prospectively plan modifications, adaptive trials tend to require versatile technology to support their complex and ever-changing nature.