Photography: Comstock
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The issues surrounding clinical trial transparency and disclosure of information regarding active clinical trials and clinical
trial results are in the limelight as never before.
It started with front-page headlines about the legal actions taken by New York Attorney General Eliot Spitzer against a handful
of major pharmaceutical companies suspected of concealing negative trial results of marketed therapies. The issue has since
snowballed to include primetime news reports and public outcries for disclosure from patient advocacy groups and influential
organizations such as the American Medical Association, the International Committee of Medical Journal Editors (includes JAMA, NEJM, and others), and even the World Health Organization.
Faced with addressing this increasingly public issue, biopharmaceutical companies began taking proactive steps to make more
clinical trial information available and easily accessible. Pioneering the industry's effort, Eli Lilly, GlaxoSmithKline,
and Forest Labs have all developed online clinical trial registries on their corporate Web sites. The Pharmaceutical Research
and Manufacturers of America (PhRMA) developed a registry with pledged support from its member companies. Even the International
Federation of Pharmaceutical Manufacturers & Associations, which includes PhRMA and other industry trade groups, has developed
plans for action. Most recently, Roche has begun posting what will be nearly 2000 trials for both ongoing and completed studies
with a third-party commercial registry.
Figure 1. Clinical trial disclosure—A rapidly changing landscape.
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Almost all industry stakeholders support disclosure. However, even with all their influence, credibility, and respect in both
the health professional and consumer communities, Congress would not let industry figure out the trial transparency issue
on its own. Late this February, Congress took serious action.
On February 28, 2005, Senators Charles Grassley (R-IA) and Christopher Dodd (D-CT) introduced legislation called the Fair
Access to Clinical Trials Act of 2005—the FACT Act. The FACT Act calls for the current clinical trials registry located at
http://www.clinicaltrials.gov/ to be rebuilt and expanded to include information about the results of clinical trials, and to apply to all clinical trials
for drugs, biologics, and medical devices. A daunting task, the proposed legislation would require that:
- Trials must be registered in the data-base in order to obtain approval from a U.S.-based Institutional Review Board
- Researchers promptly disclose the objectives, eligibility criteria, sources of funding, and anticipated timeline of clinical
trials
- Results of clinical trials be available to doctors and patients
- Strong enforcement mechanisms, including civil monetary penalties of up to $10,000 per day for sponsors that do not comply.
This is by far the most aggressive legislative action taken to date to force the issue of trial transparency.
Figure 2. Industry adoption takes hold.
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Biopharmaceutical companies, as well as government researchers, are scrambling to figure out how they will respond if the
legislation is ever passed with its current requirements. They are grappling with various challenges: how to collect all of
the information internally and get it into the right format for posting; proper staffing for processing, posting, and maintaining
this information; combatting competitors' use of detailed information to make adjustments to their own strategy; and last
but not least, what results—positive or negative—are statistically significant enough to report.
