Institutions Still Sluggish to Report Clinical Trial Results, Analysis Finds
A number of academic and medical institutions are still not reporting their trial results as required by federal law, a new analysis shows.
The report shows that the University of Virginia (UVA) accounted for the greatest number of clinical trials that had not been reported to ClinicalTrials.gov, with 28 trials. That was followed by Massachusetts General Hospital (17 trial results missing), devicemaker Cutera (16 missing) and Henry Ford Health System (15 missing).
TranspariMED, a UK-based advocacy group for clinical trial transparency, evaluated data from Oxford University’s FDAAA Trials Tracker for its report. Despite the law requiring sponsors to report results within a year of study completion, the FDAAA tracker shows that more than 3,000 trials still aren’t compliant.
Overall, large pharma companies have been notably more compliant in uploading their trial results on time than smaller-sized companies and academic/medical centers. To date, the FDA has not yet imposed fines for noncompliance with trial reporting requirements, though it has the legal power to do so. According to TranspariMED, the FDA could have collected $155 million from Cutera alone.
Loyola University and Syneron Medical, another devicemaker, had 11 results missing apiece, while Albany Medical College and the University of Southern California both failed to report results for 10 of their trials. Others on the list included Stony Brook University (9 trials), Augusta University, the University of Texas, Galveston, the University of Cincinnati and the University of New Mexico (8 trials each).
In terms of percentages, the findings were mostly dismal. Cutera did not report on-time results for a single one of its trials, making it the worst offender identified, percentage wise, in the analysis. Albany Medical College reported just 17 percent. Syneron Medical submitted due results for merely 27 percent of its trials, UVA reported results for a third (32 percent) and Henry Ford Health System reported results for 38 percent. Loyola was more diligent about its results reporting than these others but still reported less than half (48 percent) of its results.
The University of Southern California, however, reported nearly two-thirds (62 percent) of its due trial results, and Massachusetts General Hospital far and away led the pack, reporting a majority (86 percent) of its results.
The advocacy group, which contacted underperforming institutions in November 2021 in an attempt to encourage them to report missing results, found that several entities — UVA, Cutera and Syneron Medical among them — still haven’t moved to become more compliant. And Massachusetts General Hospital, one of the nation’s most active conductors of trials, still came up short compared to similarly sized organizations that had perfect or nearly perfect reporting rates.
Some have begun turning it around, though. The University of South Florida, for example, reported missing results for 10 of its trials since November, the University of Florida reported nine (achieving a perfect reporting rate) and the University of Washington submitted eight. The University of Southern California was moved to report results for seven trials, the University Hospitals Cleveland Medical Center six and Sol-Gel Technologies four. Thomas Jefferson University and Henry Ford Health System had taken action to submit missing results for four trials since being contacted in November, while Fox Chase Cancer Center uploaded the missing findings for two of its trials.
In a response to a CenterWatch Weekly inquiry, UVA said that its School of Medicine’s Clinical Research Office is currently working with their principal investigators to address the missing results and become compliant. Cutera did not respond to a request for comment.
Read the full report here: https://bit.ly/3r9ODJB.