When Congress passed a bill in September 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.
For manufacturers and researchers alike, “there is a tremendous incentive to go on, to forget about the old and move on to the new,” said Drummond Rennie, a deputy editor at The Journal of the American Medical Association, who has written critically about clinical trials.
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.
In August, for example, the Food and Drug Administration sent a warning to Boston Scientific after investigators discovered the company’s diligence in following up with patients faltered around the time it dropped a product under development.
Paul Donovan, a spokesman for Boston Scientific, said that the company was moving to address the FDA’s concerns. While six patients involved in the study have died, Donovan said that the company did not believe that those deaths were related to either the stent or burst aneurysms.
“There were instances of reporting that was not done in a complete and timely manner, and we are addressing these shortcomings,” Donovan said.