Perceptive survey highlights growing interest in adaptive trial designs

25-Apr-2011 - Last updated on 26-Apr-2011 at 09:51 GMT

Perceptive Informatics, the eClinical solutions provider and Parexel subsidiary, has released the results of a global survey which shows a growing interest in the implementation of adaptive trial designs.

Entitled “Implementing Bayesian Response Adaptive Trials,” the survey was conducted during a recent webinar presented by Perceptive and UK-based science and technology consultants, Tessella.

It canvassed the opinion of more than 300 industry professionals representing a broad range of clinical, statistical and regulatory functions.

The results revealed that 80 per cent of respondents were considering implementing some type of adaptive design in the next twelve months. Of that 80 per cent, 76 per cent were considering designs that drop treatment arms at fixed interim analyses.

However, only 24 per cent of respondents said they expected to implement designs that regularly adjust the randomisation ratio throughout the study – a technique known as response adaptive design.

Acceptance concerns

Commenting on the findings, Damian McEntergart, senior director of statistics and product support at Perceptive, said: “Following the FDA draft guidance on adaptive trials, increasing implementation of these designs has helped to alleviate regulatory acceptance concerns within the industry.

“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.”

McEntergart said Perceptive remained committed to “driving the industry” in the use of eClinical solutions to support complex adaptive trial designs, and the associated management challenges.

“We are focused on helping the industry to successfully implement adaptive trials, which can enable better decision-making about compounds and reduce the time between development phases,” he said.

Interoperable solutions

Perceptive claims to have already supported the implementation of over 100 adaptive trials through the provision of interoperable eClinical solutions from its eClinical Suite, including electronic data capture (EDC), randomisation and trial supply management (RTSM) technologies, and electronic patient reported outcomes (ePRO).