Clinical Trials Reporting and Publication

Publication Date: July 2007

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

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Abstract:

The central issue before Congress with respect to clinical trials reporting and publication is how to balance the potential beneficial public health effects of requiring that clinical trials data be made public with the burdens that such requirements may place on companies and their innovation. Clinical trials, which are conducted regularly to test the effects of new pharmaceuticals and medical devices, cost a significant amount of money, and by their nature may present some risk to the people who participate in them. Manufacturers as well as medical journal editors have been reluctant to publish clinical trial data indicating that products in development are harmful or ineffective. The availability of such information might save a duplication of effort and studies that harm or fail to help patients.

While current federal regulations require the publication of some clinical trials data, and some private entities have taken steps to encourage publication, there is no requirement that the public have access to all standardized clinical trials data -- be it notice of trial launch or research results through a centralized system such as a registry. Food and Drug Administration (FDA) regulations require sponsors of trials that test the effectiveness of new drugs for serious or life-threatening conditions to register with the Department of Health and Human Services (HHS) at [http://clinicaltrials.gov/], although not all such trials are listed there. Clinical trial data from National Institutes of Health (NIH)-funded research may be made public through a Freedom of Information Act request only if the findings were used by the federal government in developing an agency action that has the force and effect of law. The International Committee of Medical Journal Editors (ICMJE) requires, for publication of clinical trial results, that a sponsor have posted its trial in a public registry before enrolling patients. A voluntary registry of recent controlled trials results was created in October 2004 by the Pharmaceutical Research and Manufacturers of America (PhRMA).

Proposals for public access to all or most clinical trial data raise a variety of issues. These relate to the goals of providing public access, the appropriateness of the information and its presentation for the audience, the timing of a trial's inclusion, whether reporting should be mandatory, potential conflicts of interest, and whether medical device trials should be included.

Eight relevant bills have been introduced during the 110th Congress. One, the Fair Access to Clinical Trials (FACT) Act (S. 467), would require the registration of clinical trials, some of which must currently be registered at [http://clinicaltrials.gov], and the subsequent posting of their results. The act would also make public certain information about FDA's non-approval actions, which is currently not required to be released. Seven other bills, the Food and Drug Administration Revitalization Act (S. 1082), the Enhancing Drug Safety and Innovation Act of 2007 (S. 484 / H.R. 1561), the Food and Drug Administration Safety Act of 2007 (S. 468 / H.R. 788), and the Pediatric Medical Device Safety and Improvement act of 2007 (S. 830 / H.R. 1494) also contain provisions about clinical trials reporting and publication.

This report will be updated on a regular basis.