Clinical Trial Results Reporting Tracker Launched by AllTrials

The international initiative AllTrials has launched a new online tracking tool that publicly discloses which research entities have not reported data from clinical trials.

AllTrials, founded in 2013, with institutional members including BMJ, PLOS, and the Dartmouth Institute for Health Policy and Clinical Practice, among others, calls for all past and present clinical trials to be registered, and for the results of these trials to be reported in accordance with the Declaration of Helsinki, the World Medical Association’s statement of principles for medical research involving people.

The tool, the FDAA TrialsTracker, lists all clinical trials by sponsor name, itemizes ongoing trials, and highlights any trials that are overdue for reporting their results. Additionally, the tracker notes the number of days that results are past due, and how many dollars the FDA could impose in fines for the failure to report results.

AllTrials announced the new initiative in an open letter to FDA Commissioner, Scott Gottlieb, MD, in which the group noted that FDA has “…the power to sanction those who break this law, including the levy of fines up to $10,000 a day against clinical trial sponsors who fail to publish their trial results on ClinicalTrials.gov,” based on the fact that the FDA is the body responsible for compliance with the FDA Amendments Act of 2007. Under the law, the FDA can sanction those who do not post summary results and adverse event information within 13 months of trial completion.

“We know that the FDA takes patient safety seriously and we are sure that you will follow the tracker to act on unreported trials,” said the group’s open letter. “However, to assist you further we will also write weekly with the list of trials that have breached their reporting requirements and a rolling total of the fines that these should incur,” say the authors.

The launch of the tracker comes on the heels of a 2017 publication in BMJ of a study, led by AllTrials members, that assessed the clinical trial reporting policies of 42 companies in the European Union, United States, Japan, and Canada. The researchers found that company policies on reporting varied widely, often had unclear language, and exhibited internal contradictions. “Many companies lacked commitments on basic issues such as trial registration and the sharing of summary results,” said the authors, adding that “Transparency commitments generally did not include trials for off-label uses, even though these are common in clinical practice; and commonly failed to include phase [4] trials.”

Reference

Goldacre B, Lane S, Mahtani K, et al. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. Published July 26, 2017. BMJ. doi: 10.1136/bmj.j3334.