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Shopping for clinical trials
New NIH Web site raises ethical issues
As mandated by Congress, the National Institutes of Health (NIH) has just launched a new Web site, ClinicalTrials.gov. Its purpose is to provide "patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions." This is a boon for patients interested in participating in research projects, but it is also a turning point in how we think about clinical research participation. No longer will participation be determined primarily by referrals from physicians. The new approach raises issues similar to ones that surfaced with direct marketing of prescription drugs to the public, and it should prompt a careful look at the ways in which we protect the rights and interests of research subjects.
Who needs a Web site for clinical trials?
Whether or not a patient enters a research trial depends on a number of factors, most of which have nothing to do with actual eligibility to participate.
The most important factors may be whether physicians inform their patients about available clinical trials and recommend that they participate in them. But information and referrals from physicians require that they know about relevant research. With many thousands of research trials undertaken every year, it is understandable that doctors don't always know all research options for patients.
Since patients have been largely dependent on their physicians for such information, the doctor's office became a bottleneck. ClinicalTrials.gov offers a way to get around the bottleneck and deliver information about clinical trials both to doctors and their patients. It effectively offers a catalog of the research trials available for particular diseases, for patients with specific diagnoses and in various regions of the country.
Changing the presumption from protection to access
The need for better information about clinical trials stems from a shift in the way policymakers and the public view participation in clinical research.
Research subject protection policies were created in the aftermath of scandals in the 1970s, in which subjects were exploited by research that held no medical benefit for them. These policies were based on the presumption that potential subjects needed first and foremost to be protected from the harms that research posed. Any medical benefits that subjects might realize from their participation in research were seen as a secondary outcome.
But 20 years later, the presumption has changed dramatically. Policies now require inclusion of groups like women and minorities in research, based on the belief that there are real benefits from research participation, and that both individuals and the groups from which they come ought to have access to those benefits.
So the presumption has shifted from protecting of subjects from risk to assuring subjects access to the benefits of research participation. ClinicalTrials.gov will help facilitate that access by providing information about what research is being carried out.
Advertising research directly to the public?
While the new Web site will certainly be a valuable tool for patients and their physicians, potential subjects must still be protected.
It will be important to assure that the Web site will operate more as a clearinghouse for information and less as a means for sponsors to attract research subjects to their studies. The marketing potential for research sponsors is clear, and it is only a short step to the look and feel of prescription drug advertising to the public.
ClinicalTrials.gov will be a valuable tool for education, but is a very bad idea for advertisement. The ongoing challenge will be to assure that it continues to deliver valuable information to patients -- not just patients to clinical trials.
"Ethics Matters" Archive
where you'll find other columns from Jeffrey Kahn
on a wide range of bioethics topics.
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