New research conducted by British researchers has revealed that only 41% of clinical trials sponsors reported results within a year of the trial’s completion in the US.
At least one in every three trials (36%) went unreported, according to findings published in The Lancet.
The study found that trials with non-industry sponsors such as universities, governments, and hospitals are more likely to breach the rules than those sponsored by the industry.
US Government-sponsored trials are least likely to post results on-time at the ‘ClinicalTrials.gov’ clinical trial registry.
Despite legal efforts to curb lapses in the documentation of the reporting of negative trial results, several sponsors do not report their findings and this means that patients and healthcare professionals are unaware of the benefits and drawbacks of treatments.
Oxford University research lead Dr Ben Goldacre was quoted by the news agency as saying: “Doctors and patients cannot make informed choices about which treatments work best when the results of clinical trials are withheld.
“We’ve known about this problem for at least three decades. It took us 25 years to get to the point of passing the law in 2007. It took another 10 years to have the final rule implemented. After all of that time, we now see that law is being very, very widely ignored.”
The authors involved in the findings noted that the high rate of non-compliance found in the new study is more likely due to the lack of enforcement by regulators.
University of Lausanne, Switzerland lead author Dr Erik von Elm, who was not part of the study, said: “Any law is only as good as its enforcement.
“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.”
As per the US FDA, if any organisation is against the implementation of the law, they are liable to pay a fine of $12,000 per day for everyday results that are overdue.
It looks like the FDA has neither monitored compliance nor issued any sanctions for those who breached the law.
In April last year, US lawmakers introduced a new legislation, the Henrietta Lacks Enhancing Cancer Research Act, which would examine access to government-funded cancer clinical trials.