May 4, 2007 / 4:25 PM / 12 years ago

WHO moves to boost online data of clinical trials

GENEVA (Reuters) - The World Health Organization (WHO) said on Friday it was improving access online to data on clinical trials in the wake of high-profile cases of drugs being tested with possibly harmful side-effects.

A new Web site aims to help researchers, doctors and patients obtain reliable information on high-quality clinical trials, it said in a statement.

Currently a “significant proportion” of trial research is never published, meaning doctors can lack information about treatment options, according to the United Nations agency.

Another problem is the selective reporting of clinical trial findings, which can end up being misleading, WHO officials say.

“WHO believes that the registration of clinical trials is a scientific, ethical and moral responsibility.”

Initially, data from 50,000 clinical trials provided by three registers — in Britain, Australia/New Zealand and the United States — have been put on the WHO site, which is

Registers submitting data must ensure they meet a minimum quality standard and that all trials are registered before any participants are recruited. Data will not be accepted directly from drug companies.

“The Clinical Trial Search Portal is a collaborative international initiative led by WHO that facilitates the identification of all clinical trials, regardless of whether or not they have been published,” said Tim Evans, assistant WHO director-general for information evidence and research.

Since Merck & Co Inc’s 2004 recall of painkiller Vioxx, after a clinical trial found it increased the rate of heart attacks among long-term users, concerns have grown about side effects of some prescription medicines.

In 2004, the U.S. Food and Drug Administration advisory panel began requiring a black box warning on prescriptions for selective serotonin reuptake inhibitors (SSRI), a type of antidepressant, based on reports that fluoxetine (Prozac) increased suicidal thoughts in children and adolescents.

Such cases have led to growing pressure for greater transparency.

“You can go to one place (online) and search all registers at once and identify clinical trial research underway around the world,” Davina Ghersi of WHO’s department of research policy and cooperation said.

The network of registers, which are required to disclose their ownership, governance structure and for-profit status, will be expanded to make it more comprehensive.

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