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UN health agency sets new standards for registration of all human medical research

UN health agency sets new standards for registration of all human medical research

In an effort to respond to growing public demands for transparency in clinical trials involving humans, the United Nations health agency today called on research institutions and companies to register all such studies and include details ranging from the source of funding or material support to the primary and secondary sponsors.

“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,” World Health Organization (WHO) Assistant Director-General Timothy Evans said.

As part of the International Clinical Trials Registry Platform, a major initiative aimed at standardizing the way information on medical studies is made available to the public, WHO is recommending that 20 key details be disclosed at the time studies are begun.

Beyond funding and sponsorship these include such practical matters as e-mail address, telephone number or postal address of the contact for general queries, including information about current recruitment status, and the countries for participant recruitment.

Other key details cover the health conditions studied such as depression, breast cancer or medication error; specific name of the intervention such as drug, low-fat diet or exercise; expected outcomes; and participation criteria, including age and sex.

The planned Platform will not be a register itself, but rather provide a set of standards for all registers. Currently, there are several hundred registers around the world but little coordination among them. The Platform seeks to bring participating registers together in a global network to provide a single point of access to information stored in them.

Before making today’s recommendations, the Registry Platform initiative consulted with all concerned stakeholders, including representatives of pharmaceutical, biotechnology and device industries, patient and consumer groups, governments, medical journal editors, ethics committees, and academia over a period of nearly two years.

Although registration is voluntary, there is a groundswell of policies aimed at spurring registration of all clinical trials. In July 2005, for example, the International Committee of Medical Journal Editors, a group representing 11 prestigious medical journals, instituted a policy whereby a scientific paper on clinical trial results cannot be published unless the trial had been recorded in a publicly-accessible registry at its outset.

Some groups have raised concerns that these new requirements could jeopardize academic or commercial competitive advantage if they apply to preliminary trials of new interventions. Similar concerns have been voiced about the requirement to disclose certain items - such as the scientific title of the study, the name of the treatment being tested and the outcomes expected from the study - at the time of registration.

Later this year, the WHO Registry Platform will launch a web-based search portal where scientists, patients, doctors and anyone else who is interested can search among participating registers for clinical trials taking place or completed throughout the world.