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Pharma’s Mixed Response to Trials Database

By Mark D. Uehling

Feb 15, 2006 | With a seasonal shopping virus striking the nation at the usual time, some readers may have missed a late December 2005 article in the New England Journal of Medicine (NEJM). The article by Deborah Zarin and colleagues examined recent trends in the public registration of clinical trial data in the main U.S. database —

In 2004, a group of influential medical journal editors threatened to bar publication of clinical trial studies that had not been registered in a suitable public database. A deadline of September 2005 was set. Zarin’s article was the first detailed look at pharma’s reaction.

In some respects, surprising progress has been made: 76 percent of the trials registered by industry from May to October, 2005, had information about the primary outcome of the study. The overall increase of trials being registered is also impressive, and quoted to be 73 percent, though no one knows exactly how many trials there are.

Other observers, however, look at the same data and are less impressed. Among them, the editors of the NEJM, who published an editorial critical of the response of some Big Pharma companies.

As Jeffrey Drazen and Alastair Wood point out, many companies fill in the “Intervention Name” field in the database in good faith. But GlaxoSmithKline and Pfizer provided meaningless data in that field in 21 and 11 percent of their registered trials, respectively.

When it comes to telling physicians about primary outcome, Novartis completes the “Intervention Name” field in the database just 3 percent of the time. Merck supplies that information just 20 percent of the time. The fact that their gnarliest competitors do routinely offer such information punctures the idea that such information is of a proprietary or competitive nature.

The NEJM editors state: “In our opinion, it is unacceptable for a trial sponsor to not register its trial in a complete, meaningful, and timely fashion. We call for all clinical investigators and patients to participate only in fully registered trials.”

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