Washington Editor

An initiative started by the American Medical Association to create a national clinical trials registry appears to be gaining momentum around Washington.

It started in late June when the AMA House of Delegates approved a proposal calling for the Department of Health and Human Services to establish a new registry that would ensure all trials, with negative or positive results, are made publicly available.

The AMA also called for institutional review boards to require companies to register in the database as a condition of approval for all trials.

Since release of the proposal, a few lawmakers have reportedly jumped on the bandwagon by asking the National Institutes of Health and the FDA to provide guidance as to what can be done to improve such a database, which is currently available under the FDA Modernization Act of 1997.

The law requires companies and other organizations to make public studies of experimental medications for serious or life-threatening diseases. The FDA reportedly does not enforce the regulation.

However, trial data that are available can be found on ClinicalTrials.gov, an Internet data bank of study information launched in February 2000 by the NIH's National Library of Medicine.

Indeed, the Chicago-based AMA took up the issue out of concern that negative or null trial results were not being published. Joseph Heyman, an AMA trustee, said the association believes that pattern of publication might distort the medical literature, affecting the validity and findings of systematic reviews, the decisions of funding agencies and, ultimately, the best practice of medicine.

Also, the AMA believes investigators and authors are reluctant to submit poor trial results because they don't believe the medical journals will publish them.

Journals are more interested in publishing studies that are likely to affect clinical practice, and, as a result, confirmatory trials with negative results and trials that show no significant result are less likely to be published, the AMA said.

Meanwhile, the Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA) in the last week or so has updated, revised and clarified its set of principles for the conduct of clinical trials and the communication of results of trials.

Court Rosen, PhRMA spokesman, told BioWorld Today the organization's principles are voluntary. "Basically these are principles the PhRMA board has adopted for its member companies to effectively communicate in a timely way clinical trial results," he said.

Many of PhRMA's principles reflect existing practices within the industry. PhRMA recommends that trials are conducted in accordance with applicable laws and regulations, as well as recognized principles of Good Clinical Practice. It also suggests that the independence of clinical investigators and others involved in clinical research is respected, so they can exercise their own decision-making authority to protect research participants. PhRMA said trials should be reviewed by institutional review boards or ethics committees before beginning and there should be timely communication of meaningful results.

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