alexa Internal Facilitation Committees Improving Protocol Des
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Research Article

Internal Facilitation Committees Improving Protocol Design Feasibility

Kenneth A Getz* and Jennifer Kim

Tufts Center for the Study of Drug Development, Tufts University, USA

*Corresponding Author:
Kenneth A Getz
Research Associate Professor
Director of Sponsored Research Programs
Tufts Center for the Study of Drug Development
Tufts University, 75 Kneeland Street
Suite 1100, Boston, MA, USA 02111
E-mail: [email protected]

Received date: July 27, 2013; Accepted date: September 05, 2013; Published date: September 09, 2013

Citation: Getz KA, Kim J (2013) Internal Facilitation Committees Improving Protocol Design Feasibility. Pharmaceut Reg Affairs 2:111. doi:10.4172/2167-7689.1000111

Copyright: © 2013 Getz KA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Biopharmaceutical companies are actively seeking ways to simplify study design complexity and improve protocol feasibility. One new approach adopted by a growing number of companies has been to establish internal facilitation committees charged with evaluating the benefits and costs of various study design elements (e.g. volunteer eligibility criteria and protocol procedures). In late 2012, Tufts CSDD conducted in-depth interviews and compiled and analyzed profiles of internal facilitation committees implemented recently by ten major pharmaceutical. This article discusses common committee characteristics and goals and highlights implementation challenges and early measures of committee impact.

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