A Taxpayer-Funded Clinical Trials Registry and Results Database 英文参考文献.docVIP

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A Taxpayer-Funded Clinical Trials Registry and Results Database 英文参考文献.doc

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A Taxpayer-Funded Clinical Trials Registry and Results Database 英文参考文献

Open access, freely available online Essay A Taxpayer-Funded Clinical Trials Registry and Results Database It already exists within the US Food and Drug Administration Erick H.Turner O ver the past several years, there has been growing concern about selective publication of 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 testi?ed in a United States Congressional hearing, outlining elements necessary to make such a registry effective [7]. Momentum for a comprehensive clinical trials registry is also building internationally [8]. 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, clinical trial results [1,2]. The debate has intensi?ed since New York State Attorney General Elliot Spitzer ?led suit against GlaxoSmithKline on June 2, 2004, alleging that the company was hiding data regarding the ef?cacy and safety of selective serotonin reuptake inhibitors in pediatric patients with depression [3]. 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 [4]. 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—dif?cult to enforce. For example, ClinicalT, 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 [5]. Thus, one can check a num