Clinical trials—or the lack thereof—often play a central role in cases involving dangerous drugs and medical devices. If and when manufacturers had knowledge of the dangers associated with their products goes directly to the liability of those manufacturers. All too often, clinical trial data concerning safety or effectiveness of a drug or medical device is not disclosed by manufacturers, or this information emerges years later as a result of litigation.
As the Wall Street Journal reported recently, less than half of all clinical trials funded by the National Institutes of Health (NIH) were published in peer-reviewed journals and a third of completed clinical trials remain unpublished after four years. Additionally, only 8% of the 178,000 registered clinical trials on the U.S.’s main database, ClinicalTrials.gov, currently include summaries of results. This is a significant problem, because it means that potentially important information about the safety and effectiveness of drugs is unknown to the public.
The NIH and the Food and Drug Administration (FDA), troubled by this lack of clinical trial reporting, proposed new rules recently, hoping to address this problem. These rules “aim to improve public access to information about specified clinical trials—information that is not necessarily available from other public sources.” These rules would primarily apply to “controlled, interventional studies of drugs, biological products, and devices that are regulated by the FDA, but will exclude phase 1 studies of drugs and biological products and feasibility studies of devices.”
As part of these new rules, the NIH is seeking to expand the scope of data which must be submitted to include summary results for products that are not currently approved in the U.S., as well as tables showing breakdowns of adverse events. NIH director Francis Collins noted that “We need to be sure results are finding their way into the view of the public and other researchers…This is a very significant step forward.” FDA Commissioner Margaret A. Hamburg noted that “This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices and biological products available to the public…[i]t would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products.” As the Wall Street Journal has reported, this proposed rule has been well accepted by many researchers.
The NIH has clearly identified a problem—the lack of transparency in the reporting of clinical trial results. What is less clear is whether the new proposed rules will actually solve this problem. Even before these new proposed rules, the NIH and the FDA have had the authority to punish violators who fail to register or publish their clinical trial results. The NIH can withhold grant money from violators and the FDA can levy civil penalties for unreported trials. But currently these penalties are seldom enforced.
The success of the NIH and FDA’s new proposed rules will almost certainly turn on whether or not the rules are enforced and violators are punished. Until the NIH and FDA exercise their ability to punish violators, researchers may have no more reason for concern than they did before these new rules. While these proposed rules seem to be an overdue step in the right direction, it remains to be seen whether or not the NIH and FDA will enforce these rules.
The proposed new rules are not finalized, and the NIH is currently accepting public comments in preparing the final version of the new rules.