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WHO launches effort to standardize access to clinical trial registry data.(Practice Trends)

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| July 15, 2006 | Wachter, Kerri | COPYRIGHT 2006 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

The World Health Organization has launched a major initiative to standardize the way that information on clinical trials is made available to the public.

In an attempt to address growing public concerns about the transparency of medical research involving human participants, WHO is recommending 20 key details that all clinical trial registries should include.

"Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants," Dr. Timothy Evans, assistant director-general of the WHO, said in a written statement.

WHO's International Clinical Trials Registry Platform is not itself a registry but provides standards for all clinical trial registries. These standards require information about: sources of monetary or material support, primary and secondary sponsors, contacts for public and scientific queries, countries of recruitment, health conditions or problems studied, interventions, key inclusion and exclusion criteria, study design, date of first enrollment, target sample size, recruitment status, and primary and secondary outcomes.

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