Are Your Clinical Operations Adaptive-Ready?

The Adoption and Impact of Adaptive Trial Designs, a new report from the Tufts Center for the Study of Drug Development, confirms something that I’ve been saying for years – you can’t use adaptive designs without highly efficient operations:

Operating concerns – specifically delays and disruptions in trial execution, patient participation and distribution of clinical supplies – are the largest perceived barriers [to adoption of adaptive designs].

By all means, explore how adaptive design techniques can improve the efficiency and reduce the timelines of your next trial. But before taking the plunge, make sure you or your CRO has clinical operations that are adaptive-ready.

The Tufts report on adoption of adaptive design also shows why we can’t view adaptive design as the sole province of statisticians:

Statisticians have been instrumental in helping shape the current regulatory guidance and in promoting the benefits of adaptive designs. However, this group alone does not appear capable of driving industry-wide adoption. Organizations that have established strong proponents among therapy area heads, medical experts and clinical operations professionals in addition to statisticians are far more effective in driving successful adoption.

Statisticians play a central role in adaptive design but they can’t get their organizations to buy in. Without broader support and advocacy based on business benefits, adaptive design will remain a narrow specialty that affects a few trials rather than a key to improving productivity across the industry.

Furthermore, the need for near real-time operational capabilities and broader executive backing for adaptive design are connected. Unless operational capabilities are in place, use of adaptive designs isn’t a realistic possibility regardless of what the executives would like to do. The first step toward adoption of adaptive design is upgrading operations or working with someone who can. Executives need to buy into near real-time operations before they can buy into adaptive design.

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