Renee Galloway from the U.S. Centre for Disease Control testing for bacteria

Credit: James Gathany/CDC

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GENEVA, 19 May 2006 - The World Health Organisation today released a new list of standards for reporting on medical studies which test treatments on humans, saying that benchmarks for releasing information to the public were needed.

The U.N. health agency said that research institutions and companies should disclose 20 key details of their studies, whether they involve patients or healthy volunteers and including those at their earliest stages.

"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", said WHO assistant director-general Timothy Evans in a statement.

The WHO's new International Clinical Trials Registry Platform would not be a register itself, but rather would provide a set of standards for all registers, the agency said.

It added that it was responding to a "groundswell of policies" aimed at spurring registration.

Last year, the WHO noted, the International Committee of Medical Journal Editors, a group representing 11 leading medical journals, started a policy whereby a scientific paper on clinical trial results cannot be published unless the trial has been recorded in a publicly-accessible registry at its outset.

The WHO said that its list of standards would include disclosure of sources of financial support for a test, layman's language explaining the study, conditions and countries of recruitment of people on whom treatments were tested, age and gender data, sample sizes and information on the key outcomes of a test.
Concerns have been raised that such disclosure could jeopardise academic or commercial competitive advantage, the WHO said.

Ida Sim, Associate Director for Medical Informatics at the University of California, San Francisco, and coordinator of the WHO initiative, said such worries had been taken into consideration over the two years that it took to draft the standards.

Sim added: "Our aim is to make clinical research transparent and enhance public trust in science, but we are engaged in a fair and open process with all stakeholders. We look forward to continued dialogue about trial registration and results reporting as we move forward with the Registry Platform".

Currently, there are several hundred registers of clinical trials around the world but little coordination among them.

The WHO said that it hoped its new platform would help create a network with a single point of access to the information in the registers, including a freely-searchable Web database.