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Progress Slow for Online Clinical Trial Registries


 

NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, “but as it turns out, very little has happened,” Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

An Internet search performed at the beginning of March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

“This says something about the goodwill of the companies,” said Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post clinical trial results for all GSK drugs on its Web site.

An inquiry by the attorney general's office into data relating to off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised, and it was neither of those originally involved: Eli Lilly.

Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—“not everything you want to know, but a sense of how the study was designed, the method, and outcomes,” he said.

For the most part, the information that is posted by the company on the site is raw data: “If you were expecting something simple, it's not here. You have to have an understanding of research methodology to eval-uate these,” he said.

The “initiated trials” section lists phase 2, 3, and 4 studies that were begun since July 2004, most of which are still recruiting patients. “The idea is that once you do this, you can no longer hide the results of the study,” Dr. Sussman said.

The speed with which Lilly put such complete data on its Web site “tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies,” he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. “It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner,” he said.

The other company that agreed to post data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

An industry association, the Pharmaceutical Research and Manufacturers of America, maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

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