Pfizer and Roche have joined the ADDPLAN DF Consortium. The consortium was founded in 2013 by Novartis, Janssen Pharmaceuticals, Eli Lilly and Aptiv Solutions, an Icon company, to lead the design and implementation of adaptive trials. The goal of the ADDPLAN DF Consortium is to develop methodologies and execution technologies that improve dose-selection, which remains a major barrier to resolving high failure rates in phase III trials.
The ADDPLAN DF Consortium statisticians currently are collaborating to expand the utility of the multiple comparison procedure and modeling (MCP-Mod) approach, specifically by developing robust methodology for incorporating adaptive functionality. The current MCP-Mod procedure enables proof-of-concept (PoC) and dose selection to be established in a single trial. The ability to go beyond the current approach and include interim decision making into the MCP-Mod procedure will build in additional efficiency and flexibility.
"The membership of Pfizer and Roche, long time proponents of adaptive design, significantly strengthens the Consortium's ability to develop validated, regulatory-compliant software for the design and execution of adaptive trials," said Reinhard Eisebitt, executive vice president and head of Icon's Adaptive Trial Innovation Center. "Since its formation last year, the ADDPLAN DF Consortium has provided invaluable insight to further enhance the software, including the addition of adaptive dose-escalation functionality and more simulation metrics, improved plotting functionalities for simulation results and an extension to documentation."