Regulatory concerns about adaptive trials are easing, says Perceptive

Growing implementation of adaptive clinical trials following the publication of draft guidance on adaptive designs by the US Food and Drug Administration in February 2010 is helping to ease regulatory concerns within industry about the approach, says eClinical solutions specialist Perceptive Informatics.

The Parexel International subsidiary recently ran a global survey on plans for adaptive study designs during a webinar on “Implementing Bayesian Response Adaptive Trials”.

Presented by Perceptive Informatics with its strategic alliance partner Tessella, the webinar was attended by more than 300 biopharmaceutical industry professionals representing a broad range of clinical, statistical and regulatory functions.

The survey results showed that 80% of respondents were thinking about implementing some type of adaptive design over the next 12 months. Among these, the majority (76%) were considering designs that drop treatment arms at fixed interim analyses.

Only 24% of the positive respondents expected to implement designs that adjust the randomisation ratio regularly throughout the study (a ‘response adaptive’ design), Perceptive Informatics noted.

“Following the FDA draft guidance on adaptive trials, increasing implementation of these designs has helped to alleviate regulatory acceptance concerns within the industry,” commented Damian McEntegart, senior director of statistics and product support.

Perceptive Informatics conducted a similar survey during a webinar in 2009, when industry was still waiting for draft FDA guidance on adaptive trials.

On that occasion, it found that concerns about regulatory acceptance were the biggest barrier to the implementation of these trial designs, along with other pressing issues such as lack of understanding of new techniques and problems with rapid access to clinical endpoint data.