Adaptive Trial Designs: Understanding The Potential Of Statistical Innovation
As the clinical development landscape changes rapidly, so does the interest in ways trial sponsors can accelerate research and development programs while reducing inefficiencies, time and related cost. According to ClinicalTrials.gov, in 2020 alone, there were nearly 400 trials using adaptive designs. In comparison, from 2005 to 2018, there were less than 300 trials in total using these approaches.
The rapid increase in adaptive trials is likely tied to the FDA guidance on complex and innovative trials. Adaptive trials preserve the statistical validity of the analysis at the conclusion of the trial, even with the trial adapting to incoming data. Because these trials can respond to the data, sponsors are able to make better use of the data, which increases study efficiencies and accelerates treatment development, while also maintaining scientific and statistical integrity.
Adaptive designs can be applied across all phases of clinical research, but depending on the stage of clinical development, certain designs may be more useful than others.