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Abstract

Pharmaceutical and biotechnology companies are actively seeking ways to optimize protocol design. An emerging approach has been the creation of a new governance mechanism designed to evaluate protocol feasibility and simplify design before final protocol approval. In late 2012, the Tufts Center for the Study of Drug Development conducted a qualitative in-depth assessment of 10 major pharmaceutical companies that have implemented these new governance mechanisms since 2009. Detailed profiles of each company’s feasibility review mechanism are discussed including committee missions and objectives, positioning, composition, staffing models, reporting flow, implementation challenges, and measured impacts to date.

Keywords

protocol design protocol feasibility protocol complexity clinical data extraneous clinical data

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New Governance Mechanisms to Optimize Protocol Design

Abstract

Keywords

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