Pfizer, Roche Join ADDPLAN DF Consortium to Improve Dose SelectionBy
Pfizer and Roche have joined the ADDPLAN DF Consortium, an industry group focused on developing methodologies and execution technologies that improve dose-selection. The consortium was founded in 2013 by Novartis Pharma AG, Janssen Pharmaceuticals Inc., Eli Lilly, and Aptiv Solutions, which is part of the contract research organization ICON plc.
The ADDPLAN DF Consortium statisticians are currently collaborating to expand the utility of the Multiple Comparison Procedure and Modeling (MCP-Mod) approach, specifically by developing methodology for incorporating adaptive functionality in clinical trials. The current MCP-Mod procedure enables proof of concept and dose selection to be established in a single trial. Allowing for interim decision-making into the MCP-Mod procedure is expected to create additional efficiency and flexibility.