Following pressure from watchdog agencies and politicians, the U.S. National Institutes of Health are finally cracking down on costly research waste in clinical trials.
According to reporting by STAT News:
“In recent weeks, the National Institutes of Health has begun emailing academic institutions that failed to submit results of clinical trials to a government database…”
“More than two dozen institutions have been contacted as of this week, according to the Clinical Trials Registration and Results Reporting Taskforce, a national consortium of academic medical centers, universities, hospitals, and nonprofit organizations focused on clinical trial transparency. The taskforce is currently surveying its members to determine the extent of the NIH effort.”
STAT reports that in its letters, the NIH made clear that institutions have 30 days in which to provide evidence that results were posted to ClinicalTrials.gov, or explain why they are not required to do so.
Good but not perfect
Anthony Keyes, who co-chairs the nonprofit Clinical Trials Registration and Results Reporting Taskforce and is a program manager for clinical research projects at Johns Hopkins University, told STAT News that:
“This gesture is good overall, but could have been rolled out better by collaborating with the (trial) sites, not just sending letters out to the sites. Going to the grant person is like six degrees of separation.”
“They’re not using all the resources at their disposal. If they really want to fix the issues, I do think it should be communicated a little better.”
TranspariMED has repeatedly contacted the NIH press office for details on the scale and scope of the effort. To date, NIH has not responded.
Scope and scale still unclear
Till Bruckner, founder of TranspariMED, said:
“It is wonderful to finally see the National Institutes of Health taking its fiduciary, scientific and ethical responsibilities seriously.”
“The NIH should now provide public assurance that this initiative will rapidly be rolled out to all clinical trials missing results in violation of the law, with not a single trial left behind.”
Widepread legal violations
Federal law and NIH policy require publicly funded clinical results to be uploaded to ClinicalTrials.gov within one year of their primary completion date, and for the NIH to ensure that investigators comply with this requirement.
A recent audit found that over half of NIH funded clinical trials violated the law, prompting a group of Senators to prod the agency to get its act together.
The NIH has an annual budget of $46 billion.
Many research funders in other countries already track the fate of clinical trials run with public money due to rising awareness of the steep human and financial cost of clinical trials that remain unreported.
Billions of dollars wasted
Numerous studies show that across countries, a substantial proportion of trial results are never made public, harming patients and generating billions of dollars in direct and indirect costs for taxpayers.
Most recently, a $3.2 billion Covid drug was found to be largely ineffective after the results of a large trial were made public. There are strong reasons to suspect that much of the money spent on the drug could have been saved if the results of a dozen smaller clinical trials had rapidly been made public, but the Indian generics companies running the trials appear to have withheld the results.
In a similar vein, $18 billion were spent globally on the drug Tamiflu during the early 2000s before previously concealed trial results showed that it was largely ineffective.
The UK is so far the only country worldwide to comprehensively tackle the problem on a national level, covering both publicly funded and industry trials.