In a new report conducted by Duke Medicine, researchers discovered that sponsors supporting the use of humans in clinical trials of medical products are failing to to publicly disclose their results in a timely fashion.
The study, which is to be published in the March 12, 2015 issue of peer-reviewed medical journal The New England Journal of Medicine (NEJM), found that 13.4 percent of the more than 13,000 highly likely applicable clinical trials (HLACTs) between 2008 and 2013 reported results within 12 months of completion as dictated by the Food and Drug Administration Amendments Act (FDAAA).
The FDAAA requires sponsors of applicable clinical trials (ACTs) to report their findings to ClinicalTrials.gov within 12 months of completion.
Forbes quoted the study’s authors as having said in the report:
The human experimentation that is conducted in clinical trials creates ethical obligations to make research findings publicly available
The report examined trials funded by the medical product industry, government or academic institutions, and the National Institutes of Health (NIH) and reportedly found that the results varied based on who was funding the research.
In the case of trials funded by the government and academic institutions, only 5.7 percent were reported while the NIH disclosed 2.4 percent more with a total of 8.1 percent of their trials reported.
Industry sponsored trials performed the best out of the bunch with 17 percent of their trials reported within 12 months.
In regards to the NIH’s less than stellar performance, the deputy director of Science Outreach and Policy at the NIH, Kathy Hudson, PhD, was quoted by MedPage Today as having said in an email to the publication that the “poor results” were “simply unacceptable” and that the study confirmed the NIH’s newly proposed policy which, if enacted, will require all NIH-funded clinical trials to submit their results within the allotted time frame “or risk losing their funding.”
The poor results reporting of NIH-funded clinical trials to ClinicalTrials.gov described in the new study is simply unacceptable […] The study confirms the need for the NIH’s newly proposed policy that requires all NIH-funded investigators to submit clinical trial results information or risk losing their funding.
Sponsors of certain clinical trials have been required to register and publicly disclose basic results since 2007. The requirement, unless a legal exemption exists, is applicable to all non-phase I drugs. The report must be made within 1 year of the final data collection or termination of the clinical trial.
Penalties for failure to report include civil fines of up to $10,000 per day and loss of NIH funding.
In other health coverage here on Immortal News, the trove of sugar industry documents known as the “sugar papers” have lead researchers at UCSF to report that the sugar industry worked closely with the NIH back in the 1960s and ’70s to develop a tooth decay program for American children which strived to identify alternatives to sugar reduction even though they were aware sugar caused tooth decay as early as the 1950.
