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This page provides general information on multiplicity issues arising in pharmaceutical drug development.

This topic is managed by the Multiplicity Advisory Board:
Dr. Frank Bretz (Novartis).
Dr. Alex Dmitrienko (Lilly).

The Multiplicity Advisory Board encourages you to share your thoughts and information related to multiplicity issues in pre-clinical and clinical trials in the BioPhramNet discussion forum.

The European Agency for the Evaluation of Medicinal Products (EMEA) released Points to consider on multiplicity issues in clinical trials on Sep 19, 2002.

The FDA has been working on a draft guidance document that deals with multiplicity issues in clinical trials. According to a recent article in the Pink Sheet (July 24, 2006), the guidance document is expected to be released by January 2007; however, other sources indicate that it is more likely to happen in late 2007 or 2008.

If you would like to share your thoughts or information on this topic, the Multiplicity Advisory Board encourages you to contribute to this discussion thread in the BioPharmNet forum.

Chaired by Walt Offen (Lilly).

The Multiplicity Advisory Board is working on the development of an annotated bibliography of publications (papers, book chapters and sometimes presentations) that deal with the analysis of multiple outcomes in pharmaceutical applications. Each publication is accompanied by a brief summary that describes the proposed statistical methods and their applications to pharmaceutical research.