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Clinical trial registry analysis shows company secrecy continues

January 3, 2006

Clinical trial registry analysis shows company secrecy continues
The New England Journal of Medicine released (a free link to the full text article) an extensive review of company compliance with regulations requiring placement of information about clinical trials in the nation’s public registry

While most companies have started to list their studies by the name of the drug or a unique identifier, GlaxoSmithKline and Pfizer have placed meaningless information in the “Intervention Name” field in 21 percent and 11 percent of entries, respectively. This means that researchers and patients looking at these studies in the registry don’t know what is being tested or why.

Furthermore, information provided by companies in the “primary outcome” field varied greatly. “The Primary Outcome Measure field has been available since October 1, 2004. Before May 20, 2005, this field was commonly left blank by industry and other data providers. Since then, 76 percent of industry records have included an entry in this field, although the percentages vary widely according to company. In general, information in this field is more likely to be omitted for phase 4 trials. In addition, the quality and completeness of the entries vary with respect to standard attributes of outcome measures.”

Journal editors note that some companies remained more secretive than others about the outcomes from their research. “By October 2005, Novartis had completed this field [Primary Outcome] only 3 percent of the time, and Merck only 20 percent of the time. Again, many of their competitors were in virtually full compliance, undercutting any argument that this failure reflects a commercial imperative.” The Journal has called upon doctors and patients to participate only in fully registered and public clinical trials.

Journal editors also provide an overview of other clinical trial registry projects around the world here.