Academic journal article Bulletin of the World Health Organization

WHO Clinical Trials Initiative to Protect the Public: In Response to Calls for New Standards and Rules for the Registration of Studies Involving Humans Participants, WHO Is Developing a Common Set of Rules for Registering Clinical Trials

Academic journal article Bulletin of the World Health Organization

WHO Clinical Trials Initiative to Protect the Public: In Response to Calls for New Standards and Rules for the Registration of Studies Involving Humans Participants, WHO Is Developing a Common Set of Rules for Registering Clinical Trials

Article excerpt

WHO plans to launch a global network of clinical trial registers in May 2006, the first step towards establishing a webbased search platform where members of the public can obtain full and detailed information about clinical trials.

Currently, there are at least 50 registers of clinical trials around the world. The WHO International Clinical Trials Registry Platform is a major initiative to bring these registers together in a global network to provide a single point of access to the information stored in them.

The goal is to increase transparency and accountability on the part of companies and institutions that do clinical research, and, in turn, boost public trust and confidence in that research.

"Registration of trials promotes scientific and ethical integrity and makes research more honest. When the system is up and running there will be no hiding of results," said Dr Patrick Unterlerchner, WHO Health Systems Analyst and Assistant to the Coordinator of the project.

The initiative comes in the wake of several cases of companies withholding negative research findings that sparked public outrage. Merck of the United States withdrew Vioxx from the market in 2004 after the drug was linked to an increased risk of heart attack and stroke, and in 2003, GlaxoSmithKline of the United Kingdom warned that the antidepressant, Paxil, should not be prescribed to minors as it could increase the risk of suicide.

In response, the International Committee of Medical Journal Editors (ICMJE), representing the world's leading medical journals, agreed not to publish the results of any clinical trial unless that trial had been registered in a public register before the enrolment of the first patient. …

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