Several major US universities are still violating a key clinical trial disclosure law, while others are moving towards full compliance, data compiled by the FDAAA Trials Tracker shows.
A look at the eleven US universities with the largest number of due trials shows that many US academic institutions have by now put into place policies, processes and systems that ensure that in future, clinical trials subject to the FDA Amendment Act will post their results. However, other universities have yet to put their house in order.
The worst performer in the cohort is Columbia University, which has only made the results of 14% of applicable trials available on the registry.
What can we learn from this data?
First and most obviously, this is a problem that can be fixed, as the front-runners with reporting rates of 100% clearly demonstrate.
Second, pressure works. Only a few years ago, the vast majority of US universities were breaching the law more often than not, but following public and political pressure, many institutions took steps to address the issue.
Third, more and sustained pressure is required to ensure that all American universities meet their ethical and scientific obligations to publish the results of all clinical trials, including trials not covered by the law. For patients and the scientific community, every trial counts.
To date, the FDAAA Trials Tracker has tracked the reporting status of 1,172 clinical trials subject to Food and Drug Administration Act disclosure requirements. Out of these, 682 have failed to post results on Clinicaltrials.gov within 12 months of trial completion as required by that law. The FDA could by now have imposed nearly $390 million in fines, but has so far not collected a single cent.
The figures cited above do not include trials completed before 2017, or trials that fall outside the scope of FDAAA, for which reporting rates aare typically far lower. In parallel with strengthening their systems for reporting the results of recent trials, some universities have also begun systematically clearing their backlogs of older unreported trials. A forthcoming TranspariMED study will document the impact of these laudable efforts.
Outside the United States, the picture is likely to be far worse.
TranspariMED is not aware of a single major European university that has achieved full compliance with European Union disclosure regulations. Some UK universities have failed to post a single trial result on the European registry, and others still do not even know how many trials they sponsored in the first place.
Please see the top study here for more information on clinical trial transparency and why it is so important. Universities interested in strengthening their policies and improving their performance can find useful guidance on the website of the Clinical Trials Registration and Results Reporting Taskforce.