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Clinical Research Safety and Ethical Standards in Developing World Up to U.S. Levels, Report Says
Date:7/21/2009

Clinical Research Organizations urge full funding for FDA to conduct foreign safety inspections

Washington, July 21 /PRNewswire-USNewswire/ -- Clinical trials conducted in the developing world meet the same safety, ethical and quality standards as those conducted in the developed world. That is the conclusion of a major report released today by the Association of Clinical Research Organizations (ACRO). The report, commissioned against a backdrop of declining participation rates in the United States and recent criticism of international research by several academic journals, was developed for ACRO by VOI Consulting, Inc, a Ft. Lauderdale-based life sciences advisory and publishing company.

Based on the report's findings, ACRO, which represents the leading global Clinical Research Organizations (CROs), is urging several steps to ensure that a robust global research infrastructure continues to facilitate accelerated drug development.

ACRO initiated the report because of the dramatic increase in clinical trials conducted in emerging markets over the past decade and the concern expressed by some regarding their quality. Last year, ACRO members conducted more than 9,000 clinical trials in 115 countries adhering to the highest standards of research ethics, safety and quality. Two factors are fueling the growth in developing world trials: because fewer Americans are enrolling in trials, and because global trials enable pharmaceutical companies to bring drugs to market more quickly and cost-effectively.

With the changing landscape for CROs, the report has several key findings:

  • Global trials speed drug development -- The report concludes that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety. For example, phase III cancer trials are conducted three t
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SOURCE Association of Clinical Research Organizations (ACRO)
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