Advocates Pursue: BENEFITS AND DRAWBACKS OF PUBLIC DISCLOSURE
Proponents point to a range of benefits to be gained from public disclosure of all clinical trial results. The most obvious advantage is the increased transparency of findings that suggest health risks or questionable efficacy of a medication. Patients and physicians would have a more powerful tool to compare different drugs for similar medical conditions. Registry data could also help investigators to design future trials more efficiently, perhaps enabling them to use fewer subjects and simpler protocols by targeting their research.
However, opponents caution that a public registry may pose risks as well, for several reasons. First, public disclosure of a manufacturer’s early-phase clinical trials might help competing companies to get a quicker start in designing similar products. Smaller companies, including biotechnology firms, would be particularly vulnerable to public disclosure because their products tend to spend more time in the early stages of testing. Second, in some instances, the confidentiality of trade secrets could be at risk. Third, early-phase clinical trials, which typically involve fewer study subjects and shorter time frames than later-phase trials, are especially prone to producing misleading results. Therefore, a listing of test data related to a drug’s early testing has the potential to mislead unsophisticated users of the information.
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AN EXISTING, LITTLE-KNOWN REGISTRY
The creation of a universal public registry might actually be closer than even many advocates realize. Although it is not well publicized, a limited registry already exists. The Food and Drug Administration Modernization Act of 1997 required that clinical trials to assess the effectiveness of drugs (primarily those in phases 2, 3, and 4) for serious and life-threatening diseases be listed in a database maintained by the National Library of Medicine. It is available to the public.
To date, nearly 11,000 trials have been listed; however, most of them are sponsored by the National Institutes of Health rather than by drug manufacturers. More privately sponsored studies have been listed since 2002, when the FDA issued guidance to drug companies on compliance with the registry, but the pace of listings has been slow because of disagreement over the law’s intended scope. The FDA is reportedly reviewing its authority to enforce registration, which is limited under the law, and Congress is considering the addition of new enforcement provisions.
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The original purpose of the law was to provide patients with information on trials that they might wish to join rather than to publicize study findings. Therefore, the existing database is not a complete answer for advocates of a public registry that would list clinical results. For example, it would not have ensured public access to all findings regarding paroxe-tine. However, the existing database could provide a platform on which a broader registry could be built.
IS A REGISTRY IN OUR FUTURE?
With many prominent organizations, including some in the pharmaceutical industry, behind the idea, the creation of a clinical trials public registry in some form seems a good bet. Other trends in health care are also pushing toward the same end, particularly the move toward “consumer-driven health care,” in which patients guide more of their own care directly. Consumer information is the key to any such plan.
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The growing popularity of the Internet as a source of self-directed patient medical education has further accelerated pressures for greater disclosure of data throughout the health care system. As both advocates and opponents of disclosure acknowledge, the effects of wider clinical trial reporting on drug development, pharmaceutical marketing, and clinical decision-making could be profound.
