Perceptive survey highlights growing interest in adaptive trial designs

By Alexandria Pesic

- Last updated on GMT

Related tags Adaptive trials

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Damian McEntergart, senior director of statistics and product support at Perceptive, said: “Following the FDA draft guidance on adaptive trials, increasing implementation of these designs has helped to alleviate regulatory acceptance concerns within the industry.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

Related topics Clinical Development Phase III-IV

Related news

Show more

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Why should you use clinical trial technology?

Why should you use clinical trial technology?

Content provided by Formedix | 01-Nov-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Related suppliers

Follow us


View more