Over the past several years, there has been growing concern about selective publication of clinical trial results [1,2]. The debate has intensified since New York State Attorney General Elliot Spitzer filed suit against GlaxoSmithKline on June 2, 2004, alleging that the company was hiding data regarding the efficacy and safety of selective serotonin reuptake inhibitors in pediatric patients with depression .
The two most frequently suggested remedies for the selective reporting of clinical trials results have been to register all clinical trials and to make their results publicly available. Registries have been called for at least as far back as 1974; hundreds have in fact already been established . Shortcomings of registries include the fact that they are often not coordinated and that participation is often voluntary and—in cases where they are mandated by legislation—difficult to enforce. For example, ClinicalTrials.gov, a registry authorized by the Food and Drug Modernization Act of 1997, appears not to be comprehensive. One study found that, of 127 cancer protocols sponsored by pharmaceutical companies that met criteria for inclusion, only 48% were in fact submitted to the registry . Thus, one can check a number of registries and still have little assurance that all the relevant trials of interest have been included.included.
Increasing the pressure on pharmaceutical companies to include more trials in registries, the International Committee of Medical Journal Editors has announced that, as a condition of considering a trial for publication, member journals will require its registration in a public trials registry . Further, at the American Medical Association (AMA) Annual Meeting of the House of Delegates in June 2004, the AMA called on the Department of Health and Human Services to establish a comprehensive national registry. In September 2004, an AMA trustee testified in a United States Congressional hearing, outlining elements necessary to make such a registry effective . Momentum for a comprehensive clinical trials registry is also building internationally .
In this essay, I argue that a highly valuable but underused registry and results database for US trials already exists within the Department of Health and Human Services, specifically within the Food and Drug Administration (FDA).