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WHO seeks system for tracking global clinical trials

Groundswell of support seen for easy-access register of medical data.

Washington

The World Health Organization (WHO) hopes to earn international support next week for a far-reaching plan to set up a global tracking system for clinical trials.

The WHO will solicit support for the tracking system at its Ministerial Summit on Health Research, to be held in Mexico City on 16–20 November. WHO officials are proposing to establish an Internet portal that will give easy access to clinical-trial registries around the world. They also want to create a unified system for assigning unique identifiers to trials.

These measures are intended to reduce the duplication of trials and make it easier for medical researchers, the public, journal editors and governments to track them. By taking the lead on a global registry, it also hopes to set minimum standards for what information should be included in clinical-trial registries.

“This is a good idea that's been languishing for years and has been revitalized in the past six months,” says Timothy Evans, assistant director-general for evidence and information policy at the WHO in Geneva. “Given the groundswell of interest, we're very keen to get this trials registration into global practice as soon as possible.”

Patient advocates and health researchers have long pushed for clinical-trial registries, saying they provide a fuller picture of the performance of drugs and devices in trials than that given by the often-favourable results published by manufacturers.

Registries have only recently started to receive strong support, however, following scandals such as the year-long controversy over the possible increased suicide risk among children taking antidepressants called selective serotonin reuptake inhibitors (SSRIs), which raised the profile of the issue. The US Food and Drug Administration said last month that SSRIs increase the risk of suicide in children, but based its conclusions on unpublished data that had been unavailable to the public.

Under observation: a global registry could prevent the duplication of clinical trials. Credit: G. TOMPKINSON/SPL

“The reason this has caught on now is the SSRI issue,” says Kay Dickersin, an epidemiologist at Brown University's Center for Clinical Trials and Evidence-based Healthcare in Providence, Rhode Island, who has been working with the WHO to develop plans for a global registry. “It has captured the public imagination.”

But implementation of the WHO's global tracking system would face many obstacles, including financing — particularly for the incorporation of developing countries' clinical-trial data. The organization will find out in Mexico City next week how many nations back the concept.

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WHO Ministerial Summit on Health Research

ClinicalTrials.gov

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Check, E. WHO seeks system for tracking global clinical trials. Nature 432, 137 (2004). https://doi.org/10.1038/432137b

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