Aptiv Solutions Enables First Surrogate Endpoint-Based Adaptive Clinical Trials

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Launch of ADDPLAN® 6.1 to Expedite and Improve Decision-Making in Clinical Trials

Aptiv Solutions, a global biopharmaceutical and medical device development services company leading the design and implementation of innovative approaches that improve data quality, efficiency, and productivity of product development, today announced the release of ADDPLAN® 6.1, 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 now utilize adaptive designs to a far greater extent.

ADDPLAN® 6.1 is the latest enhancement to the ADDPLAN® family of innovative software for the design, simulation, and analysis of adaptive clinical trials. Current ADDPLAN users include industry regulators at the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals Medical Devices Agency (PMDA), more than 50 top pharmaceutical and medical device companies, and numerous leading academic researchers.

Surrogate endpoints, which include biomarkers that substitute for a clinical endpoint, are instrumental in the FDA’s commitment to “speeding access to important new therapies.” Drugs that show clinical benefit on certain types of surrogate endpoints can receive a Breakthrough Therapy Designation from the FDA that expedites development and review. As part of its Accelerated Approval program, the FDA may approve drugs for serious conditions with unmet medical needs on the basis of a surrogate endpoint.

Surrogate endpoints can also be used for interim selection of treatment arms or sub-group selection in population enrichment designs. Specifically, seamless Phase II/III adaptive designs often use surrogate endpoint analysis 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.

“Trials utilizing surrogate endpoint analysis to select treatment arms require a different statistical method than those using the clinical endpoint. ADDPLAN 6.1 is the first software to include the appropriate statistical methods for the use of surrogates in interim analysis decisions,” says Gernot Wassmer, PhD, SVP and Chief Software Architect at Aptiv Solutions. “ADDPLAN 6.1 is a powerful tool for implementing innovative designs for survival based trials, such as those in oncology or cardiovascular disease, to improve drug development decision-making.”

ADDPLAN 6.1 utilizes a variant of the p-value combination method in a closed test procedure to account for repetition of patients in the exploratory and confirmatory phases. The approach enables the use of surrogates in survival (or time-to-event) designs in both the multiple comparison and the population enrichment settings. As a unique feature, ADDPLAN 6.1 simulates how the use of surrogate versus primary endpoints impacts trial outcomes and operational requirements.

Wassmer’s team published a white paper on surrogate endpoint analysis in adaptive designs, titled “Using Surrogates for Decision Making in Confirmatory Adaptive Clinical Trials” that is available at http://www.aptivsolutions.com/addplan-surrogate-endpoint-landing-page.

About Aptiv Solutions
Aptiv Solutions is a global development services company focused on enhancing clinical trial decision-making, efficiency and productivity for pharmaceutical, biotech and medical device sponsors. It is the only CRO to offer design, simulation and execution of adaptive clinical trials and a novel statistical sampling approach to risk-based monitoring. These services span the entire product development cycle from first in human through regulatory approval to post-marketing. Aptiv Solutions has more than 850 professionals in North America, Eastern and Western Europe, Israel and Japan. Learn more at http://www.aptivsolutions.com.

ADDPLAN ® is the leading fully validated statistical design, simulation and analysis software for adaptive clinical trials and is widely used by regulatory agencies and the pharmaceutical and medical device industries. It is available in the following modules:

  •     ADDPLAN® Base: Adaptive group sequential designs and sample size re‐estimation
  •     ADDPLAN® MC: Adaptive multiple comparison procedures
  •     ADDPLAN® PE: Adaptive population enrichment designs
  •     ADDPLAN® DF: Adaptive dose finding designs

For additional details about ADDPLAN® software, including eLearning modules, pricing and ordering information, visit http://www.aptivsolutions.com/addplan-software/.


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