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Adaptive Designs Provide Clinical Trial Flexibility

Vicki-Anastasi web Kevin-Liang web Kevin-McGowan web

 Vicki Anastasi
ICON 

Kevin Liang, Ph.D.
MileStone Research 

Kevin McGowan, Ph.D. 
MCRA

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. While the structure of these trials offers manufacturers clinical and business benefits, several critical components must be considered to determine whether such a trial design fits your product’s and company’s needs.

In May, FDA released a draft guidance on the principles and benefits of adaptive designs, bringing the concept to the forefront. One of the defining features of adaptive design is flexibility during data collection. Companies are able to learn from the results of the study during its course. Preplanned study changes, such as interim analyses and goals, are set before the study begins. If goals are met by that analysis point, companies can stop enrolling patients and submit their data to FDA.

This differs from traditional or fixed studies, for which factors must be specified at the start of the study and remain unchanged.

“FDA’s guidance clarified that adaptive design is well understood within the Agency and therefore, if it’s applicable to your clinical program, it can help you collect data, have the data submitted to FDA and move forward with your commercialization plans in a more efficient manner,” says Vicki Anastasi, Global Head of Medical Device & Diagnostics Research at ICON. “You save patients, money and time to market. For FDA, that is important. If you can enroll 100 patients vs. 300, that benefits everybody. What we’re seeing from executive teams of companies is that people are looking at adaptive design as a good business model. Having more data and the ability to have data to then make decisions always tends to be a good business model.”

Adaptive design studies can be used throughout the clinical development of a device, from feasibility studies to pivotal clinical trials. Companies can consider an adaptive design for Premarket Approval applications, 510(k) submissions and Investigational Device Exemption. However, the study must be pre-approved by FDA. Thus, it is necessary to allot enough time to coordinate protocol and design with FDA and external experts.

“It could take longer to negotiate the validity of the plan with FDA,” says Kevin Liang, Ph.D., Managing Director at MileStone Research. “There should always be a good level of collaboration with FDA, but adaptive designs are more complicated, so there’s probably more FDA interaction, upfront discussion and negotiation—which is really just time.”

Pre-planning is one of the major differences between adaptive designs and traditional designs for clinical studies. The adaption must be described in the protocol and Statistical Analysis Plan submitted to FDA. Submissions should also detail key issues related to study monitoring and the role of the data monitoring committee, as well as the study decision points to document evidence of safety and effectiveness.

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