Adaptive Trial Design in Clinical Trials Growing in Popularity

A recent industry and regulatory discussion has revealed an industry-wide adoption rate of about 20 percent for adaptive trials, with an expectation of significant growth over the next several years.

One factor promoting the anticipated increase in adaptive trial acceptance is the receptiveness of FDA and EMA to exploratory phase adaptive trial design:

Regulatory agencies are concerned that early development approaches are not efficiently detecting failures prior to phase III or that decisions taken in exploratory development are sub-optimal and lead to unnecessary phase III failure. The use of adaptive design in exploratory development may help address both concerns.

Additionally, the shift to adaptive trial design in clinical trials may lead to significant cost savings for sponsors:

…early study terminations due to futility and sample size re-estimation applied across the portfolio — could save sponsor organizations between $100 million and $200 million annually in aggregate costs (direct and indirect costs) depending on portfolio size and development cycle time savings.

That’s great news for sponsors. While adaptive trial design has been around for decades, and has become fairly common for seamless phase II/III clinical trials, there’s still a substantial opportunity for sponsors and CROs to use adaptive designs in phase I and II trials.

The Budget Benefits of Phase I and Phase II Adaptive Trial Designs

Early-stage adaptive trials typically provide more information on the drug and its dosage.

As Ranganath Nayak, Ph.D. and CEO of Cytel, Inc. mentions in an interview with Medelis, phase I and phase II adaptive trials not only provide more information, but also reduce time-to-market, require fewer patients, and ensure fewer patients receive doses that aren’t effective.

All signs indicate the industry has reached the level of maturity where the benefits significantly outweigh the risks of utilizing an adaptive trial design in early-stage clinical trials.

For more details, please visit Adaptive Trial Design for Phase I and Phase II.