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

imes as fast if both U.S. and global sites are used, compared to U.S.-only sites. What takes 5.8 years to enroll takes 1.9 when a global trial is implemented.
  • Research quality standards must be met worldwide -- The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe. CROs train research staff around the world in good clinical practice (GCP) principles and proof of compliance is required by drug regulators in every major pharmaceutical market.
  • Clinical research improves local economies -- Clinical research offers huge advantages for host countries, including an influx of advanced equipment, trained personnel and high-paying jobs. The presence of CROs also results in improvements in local health systems. Clinical trial sponsors in Poland, for example, fund 30 percent of hospital cancer therapy.
  • Emerging market equals growth market -- CRO activity in Central European countries, South Korea and Taiwan is very robust, medical infrastructures are advanced and capabilities are just about on par with Western Europe.
  • "On a flattened earth with waning U.S. participation in clinical trials, global trials are helping speed important drugs to market," said Doug Peddicord, executive director of ACRO. "CROs are making sure quality and ethical standards remain consistent throughout the world," Peddicord added.

    With all the advantages of globalized clinical trials have come some rare but well-publicized lapses in standards. Most notable among them is a 1996 Nigerian trial of the antibiotic Trovan, which resulted in the deaths of 11 children.

    While Nigeria has made strides to tighten its standards, ACRO makes several recommendations to make sure the quality and ethical standards match the international spread of the trials. Among them,
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    SOURCE Association of Clinical Research Organizations (ACRO)
    Copyright©2009 PR Newswire.
    All rights reserved

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