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US-based pharma cos to provide more information on clinical trials
Washington, D.C | Monday, January 17, 2005, 08:00 Hrs  [IST]

Information about ongoing clinical trials -beyond what is required by law- will soon be made available by innovative pharmaceutical companies and posted to the government's existing clinical trial registry (www.clinicaltrials.gov). The new voluntary disclosure policy was announced recently by the Pharmaceutical Research and Manufacturers of America (PhRMA).

Under current law, pharmaceutical manufacturers are required to provide information to www.clinicaltrials.gov on clinical trials that deal with serious or life-threatening diseases and conditions. Under the new disclosure policy, PhRMA member companies will provide information about clinical trials for all diseases (i.e., not only diseases that are serious or life-threatening).

Beginning July 1, 2005, PhRMA member companies will post, on a voluntary basis, information about all new hypothesis-testing clinical trials (i.e. mid-to-late stage trials). All ongoing hypothesis-testing trials are to be posted by September 13, 2005, the release from PhRMA says.

The move is expected to greatly expand the information available to patients and physicians about clinical trials, and also to help patients track clinical trial results more easily because every trial posted will receive a unique identifier that can be matched to clinical trial results as studies are completed. The policy also encourages PhRMA member companies to establish and make public procedures for verifying compliance with the policy.

A clinical trials registry contains information (including how to enrol) about ongoing clinical trials that are open and recruiting patients, the release added.

"Patients and physicians have asked pharmaceutical companies to make available information about all clinical trials, not just some trials, and to make that information more easily accessible," Billy Tauzin, PhRMA president and CEO said adding, "We're doing this because our industry recognizes that sometimes what the law requires doesn't give patients all they need. Patients - both those with manageable conditions and those who are gravely ill - need information about new drugs that are being tested."

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the America's leading pharmaceutical research and biotechnology companies. PhRMA members invested an estimated $33.2 billion in 2003 in discovering and developing new medicines.

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