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This page provides general information on innovative approaches to the design and analysis of clinical trials, including flexible, adaptive and seamless designs.

This topic is managed by the Flexible Design Advisory Board:
Dr. Alex Dmitrienko (Lilly).
Dr. Brenda Gaydos (Lilly).
Dr. José Pinheiro (Novartis).

The Flexible Design Advisory Board encourages you to share your thoughts and information related to flexible designs of clinical trials in the BioPhramNet discussion forum.

Reflection paper on methodological issues in confirmatory clinical trials with flexible design and analysis plan
Released by the European Committee for Medicinal Products for Human Use (CHMP) on March 23, 2006.

The FDA is expected to release a draft guidance document that will describe adaptive design applications in clinical trials in 2008.

Chaired by Dr. Michael Krams (Wyeth) and Dr. Brenda Gaydos (Lilly).

Chaired by Dr. José Pinheiro (Novartis) and Dr. Frederic Sax (AstraZeneca).

PhRMA-sponsored workshop that was held on Nov 13-14, 2006.

The Flexible Design Advisory Board is working on the development of an annotated bibliography of publications (papers, book chapters, etc) that deal with innovative designs in a clinical trial setting.