When it comes to investigational drugs, devices and biologic therapies, the data is available and it shows that industry was actually 3X more likely to comply with legal requirements than academic studies after disclosure was mandated.
In 2000, Congress authorized the creation of the ClinicalTrials.gov registry to provide information about clinical trials. Seven years later, the mandate expanded to require sponsors of most trials to begin registering and reporting basic summary results on the registry so the America public could have access to the resulting data. The requirement covers non-phase-1 trials of drugs, medical devices, or biologics that had at least one U.S. research site.
The National Institutes of Health are the giant pocketbook for the federal government, with almost $30 billion in taxpayer funding each year, and yet the studies they fund lag far behind corporations small and large when it comes to being reported. Trial results were to be reported by the sponsor within one year of completing data collection yet in the first five years after its creation, comprised of 13,000 clinical trials, industry-sponsored trials had 17 percent compliance while only 5.7 percent of trials funded by academic or government sources were. By the end of the five years, it had improved, with industry reporting 41.5 percent of industry-funded trials, while 38.9 percent of NIH-funded trials reported results and only 27.7 percent of academic/non-NIH-funded trials were.
As you might expect, nearly 85 percent were designed to investigate a new treatment, about 8 percent tested a prevention therapy, and the rest were for diagnostic tools.
Penalties for failing to submit data within the one-year reporting period could be as high as $10,000 a day and/or the loss of NIH funding, but enforcement has not occurred, pending a rule approval. You can bet when that happens both corporations and universities alike will be a lot more likely to post the results. They have a year, after all.
"Patients who participate in clinical research have the expectation that the risk of participation will be offset by the creation of generalizable knowledge and the advancement of science, and that is achieved through the availability of clinical trial results," said lead author Monique Anderson, M.D., cardiologist and researcher at the Duke Clinical Research Institute. "Sponsors who lead clinical trials have an ethical and legal obligation to publicly report their findings, whether the results are positive or negative.
Published in the New England Journal of Medicine.
The Clinical Trials Transformation Initiative provided funding support, along with the National Institutes of Health Common Fund (3U54AT007748-02S1) and the Health Care Systems Research Collaboratory Coordinating Center via the National Institutes of Health (1U54AT007748-01, 3U54AT007748-02S1).
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