Perceptive Informatics, an eClinical solutions provider and a subsidiary of the Boston-based company Parexel, has results of a global survey conducted during its recent webinar entitled "Implementing Bayesian Response Adaptive Trials." The webinar was attended by over 300 professionals from the biopharmaceutical industry across a broad range of clinical, statistical and regulatory functions. Perceptive polled these professionals about their plans for the implementation of adaptive clinical trial designs.
The survey results revealed that 80% of respondents are considering the implementation of some type of adaptive design over the next 12 months. Of these respondents, the majority (76%) are considering designs that drop treatment arms at fixed interim analyses. Fewer respondents (24%) expect to implement designs that regularly adjust the randomization ratio throughout the study. This approach is referred to as a response adaptive design.
“Following the FDA draft guidance on adaptive trials, increasing implementation of these designs has helped to alleviate regulatory acceptance concerns within the industry,” said Damian McEntegart, senior director of statistics and product support, Perceptive Informatics. “An important requirement for adaptive trials is the ability to include more dose levels in phase II dose-finding studies without significantly increasing the number of study participants or the length of timelines.”