Concerns about regulatory acceptance, new techniques, and access to clinical endpoint data represent the top barriers to the implementation of adaptive clinical trial design, according to a recent survey of more than 500 biopharma professionals.
Respondents to the survey, conducted by Perceptive Informatics and partner Cytel during the webinar, "Optimizing Adaptive Trial Designs: Using Simulation Methodologies to Overcome Challenges," were able to choose more than one barrier. Regulatory acceptance concerns were cited by more than 35 percent of respondents, followed by lack of understanding about new techniques (more than 33 percent) and rapid access to clinical endpoint data (more than 28 percent). Other barriers cited by respondents included understanding and implementing complex statistical methodologies as well as difficulties in medication supplies estimation and supply chain management.
"Formal FDA guidance on adaptive trials implementation is expected later this year and should help to alleviate regulatory acceptance concerns," says Bill Byrom, Ph.D., senior director for product strategy at Perceptive, which is a subsidiary of eClinical solutions provider Parexel, in a press release "As biopharmaceutical companies focus on making reliable decisions as early as possible in drug development, a growing area 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 timeline required."
Despite the barriers, adaptive trials are gaining momentum. MacuSight, a drug company working on treatments for ocular disease, recently selected etrials Worldwide's adaptive software: MacuSight will implement the Trial Intelligence electronic data capture (EDC) and Site Intelligence interactive voice response solutions as central components of its clinical data management process.
Driving adoption of adaptive trial designs is the realization among both drugmakers and regulators that the classically structured clinical trial provides too little flexibility to make use of the knowledge generated as the trial progresses.
- here's the Perceptive Informatics release
- read the etrials Worldwide release