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If you choose to follow any links to the abstract and/or complete text of the item listed below, you will be leaving the Strategian Web site. If you wish to return to this page from the Web page you are sent to, please use the Back option of your browser. Don Kennedy The Old File-Drawer Problem. (... For years, we've been getting only part of the story on clinical drug trials. The successful ones get published and touted, but others that didn't work out so well may never see the light of day. The difficulty is that positive claims [for drugs for treating various medical conditions] are sometimes made against a background of unrevealed negative results. A clinical trial that fails to show effectiveness [or indicates safety problems] is required to be submitted to the FDA [United States Food and Drug Administration] along with the positive results. But these may not be released, because their proprietary nature is recognized under the law. Back in 1977, an advisory body to the [U.S.] Secretary of Health, Education and Welfare pleaded for public access to these data. Subsequently, consumer groups such as Public Citizen have repeatedly sued to liberate them, with only limited success. In 1997, a new U.S. federal law required companies to register [clinical] trials at a government database, later called ClinicalTrials.gov. But the FDA has lacked the authority to enforce compliance, and the database remains incomplete. Now a rescue is beginning to take shape. Revisions to the U.S. law regarding the government-enforced registry are now under discussion. The International Committee of Medical Journal Editors is also considering a proposal whereby journals that publish the results of clinical trials would require sponsors to deposit trial-related results in a national registry as a condition of publication. The American Medical Association agrees with this and has recommended that institutional review boards make registration a condition for allowing any trial to proceed. The World Health Organization also plans to propose an international registry of drug trials to national health ministers later this year. Other keywords and phrases -- government, public policy, science, selection bias -- from the text of the article) Science Volume 305, Number 5683 (July 23, 2004): page 451. How to find the above journal, magazine, or other publication? See Step 3: Locate of the Information Strategy for details. Questions? Please let me know. |
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