The public and participants of clinical trials are finding results hard to come by. Research into trials reporting found that despite legal requirements, results are not being promptly disseminated through ClinicalTrials.gov.
The research published online March 12 in the New England Journal of Medicine also noted that while compliance was poor across all funding types, the worst offenders were funded by other government agencies or academic centers, although the National Institutes of Health (NIH) did not rank high on reporting either.
Analysis by Monique L. Anderson, MD, of the Duke Clinical Research Institute in Durham, N.C., and colleagues incorporated 13,327 “highly likely applicable clinical trials.” These trials were most likely to be subject to rules in the FDA Amendments Act (FDAAA), particularly those beyond phase 1, investigating drugs, devices or biologics that terminated between 2008 and August of 2012. Applicable trials are required to report findings, particularly adverse events within 12 months of the end of the trial. They may ask for and receive extensions or report any time during the five-year study period.
Attempts to give teeth to FDAAA in recent years have resulted in potential penalties for trials that fail to report results including fines of up to $1,000 a day and/or loss of NIH funding. Enforcement, however, depends on rule approval.
They found only 13.4 percent of all trials reported summary results within 12 months of trial completion; 38.3 percent reported at any time up to Sept. 27, 2013. Trials more likely to report findings included those with industry support, FDA oversight or a later trial phase. In comparison to NIH-funded trials, the odds of an industry-funded trial reporting on time was 1.62, while for academic institution or other government funded trials odds were halved (0.58). Compared to phase 4 trials, on-time reporting of phase 3 trials was 0.6; for phase 2, 0.33; for phase 1-2 combination trials, 0.22. Trials where phase was not applicable were around half as likely to report results (0.56). FDA oversight was also significantly influential; those without oversight were a third less likely to report on time.
Within a five-year window, trial phase and funding source remained strongly associated with reporting results. Likelihood of reporting results increased but was still lower than phase 4 reporting across trial phase (phase 3: 0.8, phase 2: 0.54 and phase 1-2 combination: 0.46). NIH-funded and industry-funded trials were almost equally likely to report during this period.
"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 Anderson in a press release. "Sponsors who lead clinical trials have an ethical and legal obligation to publicly report their findings, whether the results are positive or negative.”
Anderson et al noted resources may have a role to play in the preparation of result summaries. Further, they suggested that, as with improvements to enrollment of studies in the clinical trials database, perhaps requirements for journal publication should also include reported results.