Open Access News

News from the open access movement


Thursday, October 28, 2004

More on mandatory drug trial registration in an OA registry

Robert Steinbrook, Registration of Clinical Trials Voluntary or Mandatory? New England Journal of Medicine, October 28, 2004. Reviewing the calls for mandatory drug trial registration in an OA registry from professional groups such as the AMA and the ICMJE, as well as from legislators in the proposed Fair Access to Clinical Trials Act of 2004. Steinbrook assesses the prospects without taking a position on the question. Excerpt: "Despite the support for public registration of clinical trials, the prospects for mandatory registration are uncertain. Individual institutional review boards could decide on their own initiative that registration is ethically required as a condition of their approval of trials, but they are unlikely to do so without national guidance. The [Department of Health and Human Services], whose agencies include the [Food and Drug Administration] and the NIH, has not taken a position on mandatory registration, nor have other governments. The effective dates of the ICMJE proposal are months away. Although the Fair Access to Clinical Trials Act would mandate registration, it has no Republican cosponsors in either the House or the Senate, and it was introduced as Congress was about to adjourn. The legislative outcome in the United States may depend on the results of next week's elections."