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Growing adoption of feasibility review committees

Internal committees formed to assess and challenge the feasibility of protocol design—which more sponsors have established in the past five years in response to increased study complexity and cost—are beginning to have a positive impact on streamlining protocols and improving clinical study performance. A new study conducted by the Tufts Center for the Study of Drug Development (CSDD) and Medidata Solutions found the majority of companies that have formed internal mechanisms to assess protocol feasibility and guide study design—commonly referred to as facilitated reviews—have seen measurable reductions in the number of protocol amendments and complexity.

AMCs vying to better compete for industry trials

Academic Medical Centers—facing major financial pressures on their educational and clinical care capabilities—are making a greater effort to improve the efficiency of their clinical trials, despite declines in National Institutes of Health funding and stiff competition from for-profit investigative sites.

Also in this issue:

• Challenging traditional data review models
• Patient-centric services—innovation v. process improvement
• Regulatory Update
• Month in Review
• Study Lead Opportunities
• FDA Actions
• New Drugs in the Pipeline