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."
Posted by
Peter Suber at 10/28/2004 09:52:00 AM.
The open access movement:
Putting peer-reviewed scientific and scholarly literature
on the internet. Making it available free of charge and
free of most copyright and licensing restrictions.
Removing the barriers to serious research.
I recommend the OA tracking project (OATP) as the best way to stay on top of new OA developments. You can read the OATP feed on a blog-like web page or subscribe to it by RSS, email, or Twitter. You can also help build the feed by tagging new developments you encounter.
