Data on clinical trials in people have not reached the public registry within the required deadline, "violating ethical obligations" to the trial participants.
The drug industry is the main target for public disclosure at ClinicalTrials.gov. The website was set up amid concerns that pharma sponsors and investigators running the trials "were selectively publishing trials that favored sponsors' interests," according to the lead author of a new study reviewing the registry.
And pharma has failed, in the first 5 years of the registry examined by the research, to get data onto it within the required 12 months - just 17% of industry-sponsored trials covered by the law made it to the database within that time.
But the review, from Dr. Monique Anderson, a cardiologist and researcher at the Duke Clinical Research Institute, and co-authors, finds there have been even worse levels of transparency against this measure.
In the first 5 years of the 2007 US law requiring that summary results reach ClinicalTrials within 12 months, this was observed by:
- 8.1% of trials funded by the government via the National Institutes for Health (NIH)
- 5.7% of trials funded by academic or government sources other than the NIH.
The analysis, published today in The New England Journal of Medicine, therefore suggests that the guardian of this law - the NIH, which is responsible for the ClinicalTrials service - has been the least effective at obeying it.
The deadline for results within a year was missed overall by almost 87% of more than 13,000 clinical trials included in the analysis.
The compliance did, however, improve over time - by the end of the study period, the NIH-funded trials finally reached an overall performance similar to pharma's.
But the analysis shows that it took those full 5 years of the law being in force for even the following final figures to be achieved. By the end of the analysis period, results of trials had been reported by:
- 42% of industry-funded trials
- 39% of NIH-funded trials
- 28% of academic/non-NIH-funded trials.
Co-author Dr. Eric Peterson, executive director of the Duke Clinical Research Institute, says:
"The public, as well as health care providers, want 'open science.'
This study demonstrates that despite national laws, industry- and especially NIH-sponsored trials have a long way to go."
Lack of legal knowledge in academia 'may prevent timely reporting'
Lead author Dr. Anderson offers an explanation for the lag in academic medical research enrolling people for the testing of treatments:
"Since the law's enactment, many [pharmaceutical] companies have developed disclosure policies and have actively pursued expanded public disclosure of data, but there may be a lack of knowledge about the law in academia, or a lack of resources to ensure timely reporting."
Dr. Anderson says sponsors of clinical trials have an ethical and legal obligation to disclose the findings, whether these are good or bad, adding:
"Patients who participate in clinical research have the expectation that the risk of participation will be offset by the creation of generalizable knowledge and the advancement of science, and that is achieved through the availability of clinical trial results."
ClinicalTrials was first set up by the US government in 2000 to list, for a wide public audience, all federally or privately funded clinical trials testing drug treatments falling under the regulation of the Food and Drug Administration (FDA) - all experimental drugs for patients with serious or life-threatening diseases or conditions.
In 2007, the law changed, and "FDAAA 801" required:
- More types of trials to be registered, with more information provided at registration
- Submission of summary results, including about adverse events, for all nonphase-1 trials of drugs, medical devices or biologics that had at least one US research site.
The law also introduced penalties for failing to comply, including fines of up to $10,000 a day and NIH grants being frozen. But Dr. Anderson says that, for technical reasons, "enforcement has not occurred."
Funding support for the analysis came from the Clinical Trials Transformation Initiative - a public-private partnership aiming to improve clinical trials - and from the NIH.