Kenneth A Getz and Jennifer Kim
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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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
