Progress and Deficiencies in the Registration of Clinical Trials

• Published in: The New England journal of medicine Vol. 360; no. 8; pp. 824 - 830
• Main Author: Wood, Alastair J.J
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 19.02.2009
• Subjects: Access to Information; Amendments; Biological and medical sciences; Clinical trials; Clinical Trials as Topic - legislation & jurisprudence; Clinical Trials as Topic - standards; Clinical Trials as Topic - trends; Databases as Topic - statistics & numerical data; Drug Approval - legislation & jurisprudence; Drugs; Fines & penalties; General aspects; Human subjects; Medical sciences; Registries; United States; United States Food and Drug Administration - legislation & jurisprudence; United States; Medicine; Clinical trial; Deficiency
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMsr0806582

In September 2007, President George W. Bush signed into law a bill requiring the registration of clinical trials in phase 2 or beyond and the public reporting of the results of those trials. This article reviews the initial implementation of the law and considers its strengths and weaknesses. In September 2007, President George W. Bush signed into law a bill requiring the registration of clinical trials in phase 2 or beyond and the public reporting of the results of those trials. This article reviews the initial implementation of the law and considers its strengths and weaknesses. Clinical trials are essential to understanding the efficacy of medical interventions. The ethical underpinnings of this type of research involving human subjects, codified in the Belmont Report 1 and the Declaration of Helsinki, 2 require that the results be publicly available to inform medical practice as well as future research. In addition, basic principles of evidence-based practice require the analysis of all data on a given topic; the practice of publishing only some results, but not others, 3 , 4 undermines our collective ability to make rational decisions about medical care. In Section 801 of the Food and Drug Administration (FDA) Amendments Act, 5 enacted . . .