ADDPLAN® Software Enables Use of
Surrogate Endpoints in Adaptive Trials
ADDPLAN® is the first statistical software to enable the use of surrogate endpoints to expedite interim analysis decisions in adaptive clinical trials. With this tool, survival trials for cancer therapeutics and other trials with long-duration endpoints can utilize adaptive designs to a far greater extent.
Surrogate endpoints, including biomarkers, are a key feature of the FDA’s commitment to expediting access to new therapies. They can also be used for interim selection of treatment arms or sub-group selection in population enrichment designs. For instance, seamless Phase II/III adaptive designs often use surrogate endpoint analyses to increase the speed of decision-making. Selecting Phase II treatment arms based on a surrogate endpoint can not only accelerate Phase II, but also benefit Phase III because patients in the treatment arm can continue on to the confirmatory analysis.
Learn more in the white paper “Using Surrogates for Decision Making in Confirmatory Adaptive Clinical Trials”, including:
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