The world’s largest funder of medical research, the U.S. National Institutes of Health, has pledged to crack down on research waste after a scathing report revealed that over half of its recent clinical trials failed to make their results public as required by law.
During an audit, the Office of Inspector General found that out of a cohort of 72 trials run or funded by the NIH, 25 trials were missing results on the ClinicalTrials.gov registry, while another 12 trials had posted their results late. All trials had been completed in 2018, and by law should have posted their results within twelve months.
Source: OIG report
Turning a blind eye
The audit report is scathing about NIH’s failures to follow up on violations:
“Of the 21 responsible parties associated with the Extramural clinical trials that had submitted the results of their clinical trials late (1), or not submitted them (20), only 1 responsible party received a notice of noncompliance from the Office of Policy for Extramural Research Administration. That institution’s responsible party submitted the results of the clinical trial 299 days late.”
“[NIH does] not have procedures for sending notices to responsible parties about reporting requirements in advance of the reporting deadline.”
Law-breakers received fresh grants
Even worse, NIH continued to throw good money after bad:
“NIH continued to fund new clinical trials of responsible parties that had not submitted the results of their clinical trials."
“Of the 37 responsible parties that had not complied with Federal reporting requirements, 21 responsible parties (11 Intramural and 10 Extramural) began a new NIH-funded clinical trial before submitting the late results of their previous clinical trials to ClinicalTrials.gov.”
Source: OIG report
NIH pledges to crack down
The auditors recommended that NIH “take enforcement actions against responsible parties that are late in submitting trial results or do not submit results”.
In an official response appended to the report, NIH stated that:
“[A new] ‘Clinical Trials Compliance Workflow’ and associated systems controls, is expected to provide a robust and automated system for centralized tracking of registration and reporting information, enabling NIH to take action upon the earliest notification of a potential violation.”
“Submitted RPPR [Research Performance Progress Report] for extramural grants will be assessed to ensure they meet the clinical trial registration and reporting requirements and that subsequent awards are not issued until the noncompliance is resolved.”
NIH response "disappointing and shocking"
“[The trials] database has been in existence since 2008, and has been continually updated and improved during that time. Thousands of responsible parties have used it to submit over 51,000 sets of results. Research has shown that about half of these – results for about 25,000 trials – are not available in the published literature, making ClinicalTrials.gov the unique public source of this information."
“In this context, it is disappointing and indeed shocking that NIH continues to emphasize the difficulty of posting results, rather than the scientific value and imperative to do so. I hope that this OIG report is a wake up call to both NIH and the scientific community.”
Navya Dasari, who heads the Universities Allied for Essential Medicines transparency campaign, told the outlet that:
“We know that compliance isn’t impossible. It’s simply not incentivized due to the lack of enforcement."
“To date, the (U.S.) government could have collected over $34 billion in fines to noncompliant sponsors - money that could have been used for public benefit - but has not collected a single cent."
"We need the NIH and FDA to step up, create an enforcement strategy that prioritizes trials of clinical and societal importance, and take serious action.”
NIH promises fall short
Till Bruckner, founder of TranspariMED, said:
“NIH has severely let down patients and taxpayers since 2007, when trial reporting first became mandatory. As this report documents, NIH for over a decade turned a blind eye to violations, and even rewarded law-breakers by handing them even more public money to run more trials with more patients.”
“NIH’s promises to do better in future are not good enough. There are probably hundreds of older NIH trial results still missing. NIH should show the patients who participated in those trials the respect they deserve, audit all trials going back to 2007, and ensure that every single result is made public.”
“New Zealand’s public research funder is currently auditing all trials going back to 1999. Why should American patients and taxpayers settle for less?”
A recent study of industry trials (not funded by NIH) found that 42% of new therapeutic biologics and novel drugs approved by the FDA during 2016-2017 failed to fully meet legal reporting requirements set out by the same law, FDAAA.
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The Office of Inspector General report can be accessed here or downloaded below.