New research has shown that the majority of clinical trials which should be following the US law on reporting results aren’t. Less than half (41%) of clinical trial results were reported on time and 1 in 3 trials (36%) remain unreported.
The research also found that clinical trials sponsored by companies are the most likely to have reported results and trials with non-industry sponsors – such as universities, hospitals and government bodies – are less likely (50% v 34% trials reported on time). US government-sponsored trials are the least likely to report results on time (31%).
January 2020 marks three years since a new US clinical trial law came into effect. The Final Rule of the FDA Amendment Act mandates that results from applicable clinical trials are reported onto the FDA’s register, ClinicalTrials.gov, within a year of the end of the trial. The research published in the Lancet medical journal is the first comprehensive study since the new US law came it effect in 2017. It is from Nick DeVito and Ben Goldacre at the EBMDataLab at the University of Oxford. They used data from the AllTrials FDAAATrialsTracker.
The FDA has the power to punish the organisations responsible for trials which are in breach of the law. The Agency can levy fines of up to $12,000 a day for every day results are overdue. As far as we know, the FDA isn’t monitoring compliance and has never issued any sanctions.
Síle Lane, head of international campaigns and policy, Sense about Science, which runs the AllTrials campaign said, “The FDA is not taking its responsibility for monitoring the law and punishing those who flout it seriously. Despite repeated requests on behalf of patients, consumers, doctors and people involved in clinical trials, the FDA has never taken action about unreported results. We estimate that it could have levied over $7 billion in fines since January 2018. That amount of money could fund a system to monitor results reporting and identify the researchers who are breaking the law many times over.”
Co-author of the research Nicholas DeVito from the University of Oxford said, “Over four decades since non-reporting of clinical trials was first reported, it is disappointing to see that we have only progressed to legislation being passed, and then largely ignored. The fact that the US Government cannot comply with its own laws is particularly concerning. Until effective enforcement action is taken, public audit may help. We have established an openly accessible public website at fdaaa.trialstracker.net where fresh data on compliance with FDAAA will be posted every day, identifying each individual overdue trial, and compliance statistics for each individual sponsor. We hope this will help to incentivise sponsors, and provide useful targeted information for all those who aim to comply with the law.”
The researchers identified better performance among sponsors with more experience of running large numbers of trials, when compared with those who have only ever run a very small number of projects (66% vs 21% trials submitted in time). The authors suggest that “research experience and robust internal governance processes can contribute to improved performance.”
Writing in a linked Comment, lead author Dr Erik von Elm (who was not involved in the study) from the University of Lausanne in Switzerland points out that, “any law is only as good as its enforcement”, adding that, “if this rule were to be enforced, academic sponsors would probably make substantial efforts to reduce the number of non- or late-reported trials and to improve data quality. Training, auditing and incentive mechanisms could be overseen by dedicated staff. A senior “transparency officer” versed in trial conduct and reporting could take a proactive mentoring role and help investigators overcome barriers that currently prevent them from timely reporting of trial results in registries. If completeness of reporting was a criterion in individual academic evaluations, this could have a considerable “signalling effect” within the local research community.”
Read the full research paper here www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)33220-9/fulltext