The FDA and EMA currently use ADDPLAN to evaluate drug approval applications. The PMDA’s license further demonstrates global interest and, above all, regulatory support for adaptive design.
Reston, Virginia (PRWEB) February 12, 2014
Aptiv Solutions, a global biopharmaceutical and medical device development services company leading the adoption of innovative clinical trial approaches such as adaptive design, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has purchased a global license for the ADDPLAN® platform, which it will use to evaluate both drug and medical device adaptive trial submissions. The license includes the company’s new dose-finding study tool ADDPLAN® DF, which is the first commercial tool for utilizing the MCP-Mod methodology that was recently qualified by the EMA as an efficient statistical methodology for Phase II dose finding studies.
Aptiv Solutions ADDPLAN® software platform, which the FDA and EMA also licensed earlier in 2014, allows the design, simulation, and analysis of adaptive trial designs such as early termination for futility or efficacy, sample size reassessment, population enrichment, and dose-finding. Adaptive designs uniquely allow pre-planned adjustments in reaction to interim data acquired during the investigation, thereby improving the utility of information the trial can acquire and providing opportunities for better decision-making without compromising the validity or integrity of the trial.
The PMDA’s license of ADDPLAN® is part of its ongoing effort to invest in innovation in clinical trial design, which includes the organization’s Innovative Statistical Strategies for New Drug Development project to “understand the features of innovative statistical strategies, such as modeling and simulation and adaptive design, and to discuss their use in new drug development”.
“According to a recent Tufts Center for the Study of Drug Development report, adaptive designs represent approximately 20% of clinical trials and are expected to increase in number rapidly in the next few years. A leading indicator to greater adoption is that the number of global ADDPLAN licenses has quadrupled in the last 18 months,” says Reinhard Eisebitt, Executive Vice President and Head of the Innovation Center at Aptiv Solutions. “The FDA and EMA currently use ADDPLAN to evaluate drug approval applications. The PMDA’s license further demonstrates global interest and, above all, regulatory support for adaptive design.”
ADDPLAN is professionally validated, 21 CFR Part 11 compliant, and the first software package to incorporate a majority of the requirements brought forward in the FDA’s “Draft Guidance on Adaptive Design for Clinical Trials for Drugs and Biologics”.
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.