Reducing Clinical Trial time

Adaptive clinical design can lead to significant time savings when implemented successfully, claims a new study by Cutting Edge Information, the North Carolina, US-based business consultancy firm.

However, according to the report, those savings are reliant on “executive support for, and wider acceptance of flexible trial design,” both of which it claims are needed to drive better usage of adaptive clinical trials.

Adam Bianchi, CEO of Cutting Edge Information, said: “Adaptive design isn’t a new concept, but there is a stronger demand to explore alternative trial design now.

“Rising clinical costs in R&D mean that every team needs to run faster. That, coupled with advancing technology, has supported better usage of adaptive trials.”

Shortened duration

Cutting Edge Information said its study, entitled “Clinical Operations: Per-Patient Trial Costs, Staffing and Adaptive Design,” found that almost 60 per cent of surveyed executives said adaptive design shortens trial duration, with only 13 per cent claiming it lengthened trials. Around a quarter of those interviewed said adaptive trials had no impact on trial length.

According to Cutting Edge Information, the study show an average of three months saved, with one company claiming to have saved a year to completion.

Faster decisions
The study goes on to suggest that adaptive trials enable project teams to make faster decisions about treatment lines, and make any alterations or adjustments on the fly.

Bianchi explained: “Teams can determine or even improve the likelihood for approval, potentially bringing a drug to market faster or terminating a trial that will not meet its endpoints.

“Even when development ends in a no-go decision, teams save time and money.”

Adaptive design has previously been implemented sparingly, with its use often restricted to early-stage trials.

Cutting Edge Information claims its new report “builds benchmarks for adaptive design” through the inclusion of insights from executives with experience of adaptive trials, and through examining the FDA’s recent guidance on the subject.