Despite 13-year-old legislation intended to boost reporting, little has changed—a disservice to patients who took on the risks.
The clinical trial community has not made it a priority to report and publish results of a significant percentage of heart failure studies conducted in recent years, an analysis suggests.
We’ve made the point before that failure to report the results of a clinical trial is a major concern. But it’s a point worth repeating. It’s not only disrespectful to the volunteers who participated, it puts at risk future patients, inefficient and contrary to the public interest. We’ve included links to 9 related items.
“There has been no change over time despite attempts at regulations and interventions by journal publishers and others to try to improve this,” he told TCTMD. “Our study shows there really has been no growth in this area over the last decade.”
The analysis, published June 22, 2020, in the Journal of the American College of Cardiology, examined randomized interventional trials and observational trials that began before and after passage of the US Food and Drug Administration Amendments Act of 2007 (FDAAA), which mandated trials involving FDA-regulated interventions to register and report their results to ClinicalTrials.gov, an online global database under the direction of the US National Library of Medicine.