by Medindia Content Team on  May 20, 2006 at 1:03 PM Drug News
Clinical Trials Involving Humans Should Be Registered: WHO
In an effort to respond to growing public demand for transparency in clinical trials involving humans, the UN health agency has asked research institutions and firms to register all such studies and include details like source of funding, material support and 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 Organisation (WHO) Assistant Director-General Timothy Evans said yesterday.

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

Beyond funding and sponsorship, these include such practical matters as e-mail address, telephone number or postal address of the contact for general queries; key details covering 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 there is 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.

Source: PTI News

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