NIH waste far over $100 million in medical research funding every year – new study

Research waste at the National Institutes of Health is costing U.S. taxpayers far over $100 million per year, a new study published today suggests.

Combing through NIH grants that were completed during 2017-2019, researchers found 137 clinical trials involving 41,501 children that had never made their results public in any form. The trials were funded through NIH grants worth $362 million.

Other key findings:

• 39% of all applicable NIH funding was awarded to grants with unpublished trials

• 36% of pediatric trials had not been prospectively registered

• Only 24% of trials had uploaded results onto ClinicalTrials.gov

Clarification 22 February:

In total, 200/413 trials assessed (48%) had never made their results public. The number of children who participated in those 200 unreported trials is unknown, but exceeds 41,501.

Explanation: The study found a total of 200 clinical trials that had not made their results public in any form. The 137 trials cited further above represent a subset of the 200 trials for which the researchers could definitively ascertain the number of children enrolled. For the other 63 unreported trials, there was either no trial record, or the registry still listed 'anticipated' rather than 'actual' enrollment figures, so the researchers took a conservative approach and only included verifiable participant numbers.

UPDATE 28 February:

According to STAT News:

“There’s a lot less funding directed at pediatric research and often far less clinical evidence for the interventions we use,” said Florence Bourgeois, an associate professor of pediatrics at Harvard Medical School and a co-author of the JAMA analysis. She noted that the NIH directed 13% of its 2021 budget to pediatric research.

“At the same time, studies have estimated that as many as 50% of drugs used in children are used in an off-label fashion, largely because industry is less interested in investing in pediatric conditions given the smaller markets and profitability for pediatric products. So pediatric research depends primarily on federal funding and there is a critical need for this funding to help fill in gaps.”

NIH long ignored waste

NIH are the world’s largest funder of medical research. Unreported trials are considered research waste because invisible medical research benefits neither science nor patients.

In theory, NIH have strong safeguards against research waste. Their policy requires all clinical trials to be registered and their results to be made public on the ClinicalTrials.gov registry within a year.

In practice, NIH have long turned a blind eye to the problem.

A 2022 report by the Office of the Inspector General slammed NIH for its lax oversight of public money, noting that NIH had even awarded fresh grants to researchers who had failed to make past clinical trial results public – a clear case of throwing good money after bad.

Furthermore, NIH had failed to use its legal powers to cut off funding to sponsors who failed to report results, fostering a culture of impunity among grantees, the inspectors noted.

(Canada’s public funder CIHR recently announced that it would cut off funding to researchers who fail to publish their trial results.)

Political pressure on NIH grows

There is now considerable bipartisan political pressure on NIH to crack down on research waste.

In October 2022, four Republican Senators urged NIH to sort out their act. Last month, a the Democrat chair of the Committee on Energy and Commerce also wrote to NIH, again calling for action.

To date, NIH’s public responses to criticism have been tepid.

NIH have promised to strengthen their grants oversight in future and sent a few reminders to grantees, but so far have not committed to systematically tackling the mountain of legacy research waste they let pile up for many years.

TranspariMED filed a Freedom of Information request with NIH today to learn more about its plans to rescue the results of its past clinical trials from becoming lost forever.

NIH outpaced by foreign rivals

Public funders in other countries are far ahead of NIH in curbing research waste.

In marked contrast to NIH's reluctance to confront the sins of the past, New Zealand’s funder has already completed an audit stretching back all the way to 1999. Large German public funder DFG recently launched an audit of its legacy portfolio. .

Comparable audits of trial registration and reporting are now being conducted on a regular basis by several major funders including the Norwegian Research Council, Wellcome Trust, Britain’s NIHR and MRC, and the nonprofits Cancer Research UK and PATH.

Today’s study was published in JAMA. It’s methodologically rock solid – in addition to searching ClinicalTrials.gov and the literature, the authors also emailed principal investigators to check they had not missed any publications. The NIH grants worth $362 million may have included activities additional to clinical trials. However, the $362 million research waste figure over three years very likely significantly understates total NIH clinical trial research waste because the study cohort was limited to paediatric trials.

Note: Useful datasets on who receives how much NIH funding can be found here.