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National Clinical Trials Database Legislation Introduced
Registration Already a Requirement for Some Medical Journals
[September 2005]
With the first jury verdict of possibly many Vioxx lawsuits just announced, and recent controversy over possible links between antidepressants and teen suicide, increased attention is being focused on the transparency of clinical trial results for prescription drugs. Media, concerned citizens, and legislators alike have decried the lack of information and data on many of the prescription drugs we ingest at higher and higher rates. Some see publicly accessible clinical trials databases as the answer. Tangible evidence of this interest is reflected by the recent introduction of the Fair Access to Clinical Trials (FACT) Act in Congress and the International Committee of Medical Journal Editors (ICMJE) mandated registration of clinical trials as a prerequisite to publication in member journals. (The pharmaceutical industry itself has made recent attempts to provide voluntary disclosure of unpublished clinical trial results (http://www.clinicalstudyresults.org).)
Earlier this year, Congress introduced the FACT Act in both the House (H.R. 3196, June 30, 2005) and Senate (S. 470, Feb. 28, 2005). Sponsored by Representatives Henry Waxman (D-CA) and Edward Markey (D-MA) and Senators Christopher Dodd (D-CT) and Chuck Grassley (R-IA), the FACT Act would create a publicly available, national clinical trial registry database where trials must be registered in order to obtain IRB approval. The initial registration must include information about the trial, such as the disease involved, hypothesis, study design/methodology, eligibility criteria, sponsor and investigator information, and funding sources. Under the FACT Act,
- the national database would build on http://www.clinicaltrials.gov where consumers and physicians can go currently to identify ongoing studies;
- all sponsors of privately and publicly funded studies of drugs, biologics, or medical devices with safety or effectiveness endpoints must register (phase 1 studies and most pharmacokinetic studies are not included);
- sponsors must report study results, positive or negative, and any adverse events regardless of acceptance for publication;
- sponsors must report the percentage of individuals who ceased participation as subjects and the reasons for ceasing participation; and
- in the event of non-compliance, the responsible party for the trial will be assessed civil monetary penalties for each day of non-compliance.
To read in detail both the House and Senate versions of the FACT Act, see http://thomas.loc.gov.
While it is unclear whether the FACT Act or similar legislation will ever pass, for many researchers seeking to publish, registration in a public clinical trial database is already becoming mandatory. The International Committee of Medical Journal Editors (ICMJE) has implemented a policy that its member journals (which include JAMA, New England Journal of Medicine, Lancet, Annals of Internal Medicine, among others) will consider a trial for publication only if it has been registered in a public clinical trials registry before the enrollment of its first patient. The policy applies to trials that started recruiting on or after July 1, 2005, and requires those ongoing trials not previously registered to register before Sept. 13, 2005. Under the policy, the researchers must choose a public clinical trials registry that meets specified criteria. While ICMJE did not identify any particular registry, it stated that www.clinicaltrials.gov meets the requirements. ICMJE’s stated goal of this policy is to promote transparency and to combat the harms of selective reporting. To read more about the ICMJE policy, see http://www.icmje.org/clin_trialup.htm.
For further information, please contact:
Claude P. Goetz, New York, (212) 603-6415, ClaudeGoetz@dwt.com
Kent (Bernie) Thurber, Portland, (503) 778-5202, BernieThurber@dwt.com
Jill H. Gordon, Los Angeles, (213) 633-6875, JillGordon@dwt.com
Zhi-Ying James Fang, Shanghai, (011) 8621-6279-8560, JimFang@dwt.com
Richard L. Cys, Washington, D.C., (202) 508-6617, RickCys@dwt.com
This Life Sciences Advisory Bulletin is a publication of the
Life Sciences Group of Davis Wright Tremaine LLP. Our purpose
in publishing this Advisory Bulletin is to inform our clients
and friends of developments in life sciences law. It is not
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Copyright © 2005,
Davis Wright Tremaine LLP.
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