Participants left uninformed in some halted medical trials

Healthcare Purchasing News, Dec, 2007

When Congress passed a bill this fall requiring makers of drugs and medical devices to disclose the results of clinical trials for all approved products, advocates of greater study disclosure applauded the move. But a provision that would have mandated disclosures for another group of products never made it into the final version of the bill. It would have covered products tested on patients, but dropped before marketing. "Trial sponsors can still choose to keep information about some trials confidential, creating serious ethical concerns," said Dr. Deborah A. Zarin, the director of ClinicalTrials.gov, a Web site run by the National Library of Medicine. Many experts said the recent Congressional debate underscored a troubling fact: some patients in clinical studies never learn about test results. The problem may be particularly relevant to those implanted with medical devices that stay with them long after a trial is over.

There are no data available for the number of patients who participate in studies of drugs and medical devices that never make it to the marketplace, though it is likely that the number runs into the thousands. A product may not reach the market for a variety of reasons; it may not perform well in trials, for example, or it may be rejected by regulators. Although researchers conducting clinical studies are not required to disclose test results to study participants, they must alert patients taking part in a test to emerging product dangers.

Companies also have to keep promises made to regulators at the time a trial began, like agreements to follow the health of study patients. Such promises are often required to get approval to begin trials in the first place. But researchers and manufacturers do not always fulfill even those minimal requirements. And such failing may be particularly acute in trials of implanted devices, since those products remain inside patients.

Because of loopholes in the recently passed Congressional bill, device makers will still have discretion whether to publicly reveal the results of studies. Under the law, device producers will have to report such "premarketing" studies and their results to the FDA. But that data will remain in a confidential "black box" until a product is approved; if a device is rejected or dropped, a company will not have to disclose those results or even publicly acknowledge that the trials occurred. Device makers lobbied against mandating disclosure for failed products, arguing that releasing such data would be confusing to patients and would give away valuable information to a company's competitors about devices under development that might succeed in subsequent trials. "Such disclosures could have the unintended consequence of eliminating many small device makers from the marketplace," Stephen J. Ubl, chief executive of the Advanced Medical Technology Association trade group, testified before Congress in June. (New York Times)