Erick H. Turner, A Taxpayer-Funded Clinical Trials Registry and Results Database, PLoS Medicine, November 30, 2004. Excerpt: '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...difficult to enforce....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)....[The registry is not OA.] However, in the interest of making the FDA more "transparent," and in accordance with the Electronic Freedom of Information Act, the FDA has, for the past several years, posted selected NDA [new drug application] reviews for approved drug–indication combinations on the FDA Web site Drugs@FDA ....These NDA review documents are much more detailed than the resulting package insert and often more detailed than corresponding journal publications....I therefore suggest that we increase access to the clinical trials registry and results database that already exist within the FDA. The agency could expand its implementation of the Electronic Freedom of Information Act and make all NDA reviews, at least for approved NDAs, available in the public domain.'
Posted by
Peter Suber at 12/28/2004 09:51:00 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.
