RESEARCH TRIANGLE PARK, NC--(Marketwire - April 4, 2011) -  Adaptive clinical design can lead to significant time savings when implemented successfully, according to a new study from consulting firm Cutting Edge Information. However, high-level executive support for and wider acceptance of flexible trial design are needed to drive better usage of adaptive clinical trials.

"Adaptive design isn't a new concept, but there is a stronger demand to explore alternative trial design now," said Adam Bianchi, chief operating officer of Cutting Edge Information. "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."

Accelerating Clinical Trials

The new study, "Clinical Operations: Per-Patient Trial Costs, Staffing and Adaptive Design," finds that almost 60 percent of surveyed executives said adaptive design shortens trial duration, 13 percent found it lengthened trials and about a quarter said adaptive design did not impact trial length. The study shows an average of three months saved, with one company saving a year to completion.

Adaptive design can save time by enabling project teams to make faster decisions about treatment lines and make adjustments to a trial in progress. "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," said Bianchi. "Even when development ends in a 'No-Go' decision, teams save time and money."

Big Picture Efficiency

Development teams have generally used adaptive design in limited ways, with many only utilizing the strategy in early-stage trials. The new study builds benchmarks for adaptive design, including insights from executives who have overcome barriers to adaptive trial usage and examining FDA's recent guidance on adaptive design.

Adaptive trial design is a key component being used to drive efficiency in clinical processes. Executives participating in the project focused on issues such as per-patient costs, therapeutic area differentiation, refining milestone definition, stricter budget controls, internal and external staffing, outsourcing trends and performance measurement. Their concerns span the spectrum of pre-clinical research, Phase 1, Phase 2, Phase 3a and 3b, and into Phase 4.

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Elio Evangelista