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Agreements

Date: 2014-08-01

Type of information: Collaboration agreement

Compound:

Company: Pfizer (USA - NY) Roche (Switzerland) ADDPLAN DF Consortium

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* On August 1, 2014, ICON plc ( announced that Pfizer and Roche have joined the ADDPLAN® DF Consortium. The consortium was founded in 2013 by Novartis Pharma, Janssen Pharmaceuticals, Eli Lilly, and Aptiv Solutions, which is an ICON company leading 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. Both Pfizer’s and Roche’s decision to join the Consortium comes as more companies recognise the value of adaptive design in improving decision making in exploratory development.

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 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.

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