U.S. Senators demand rapid disclosure of all NIH clinical trial results

Four Senators have written to the acting director of the National Institutes of Health demanding “accountability, transparency and results” for publicly funded clinical trials.


Their letter comes in the wake of a scathing audit report by the Office of Inspector General which found that over half of recent clinical trials funded by NIH failed to make their results public as required by law (FDAAA), and that NIH had continued to hand out new grants to institutions that had broken the rules.


According to STAT News, “the OIG findings prompted blistering criticism of the NIH, which has previously been accused of failing to properly oversee over disclosure efforts.” Clinical trials that fail to make their results public do not benefit patients or advance medical knowledge.


Noting that NIH received over $46 billion in federal appropriations this year, the Senators wrote that:


“When American taxpayers spend billions of dollars on federal programs, they expect accountability, transparency, and results. [The audit] report makes clear that the NIH must do more to hold grant recipients accountable, so that the public is able to access timely clinical trial results.”


In 2016, Joe Biden promised that he would cut funding to institutions that did not make NIH-funded clinical trials public as required by law. "I’m going to cut funding. That’s a promise,” Biden said at the time.

That promise has not been kept.


Pointed questions to NIH


The letter requests NIH to answer the following questions by 03 November 2022:


1. What steps, including those noted in NIH’s response to the OIG report, is the NIH taking to increase accountability for grant recipients? What types of enforcement measures will be put in place?


2. Please provide the status and implementation timeline of those improvements referenced in the NIH’s response to the OIG’s recommendations including NIH’s development of a centralized workflow and the establishment of an integrated electronic system to facilitate non-compliance alerts.


3. Since 2007, how many NIH-funded trials have failed to comply with federal and NIH reporting requirements? Will NIH commit to making these results public? If not, why not?


4. Please provide a list of the 37 grant recipients that failed to comply with federal and NIH reporting requirements in 2019 and 2020.

a. How much taxpayer funding did NIH grant to the 37 recipients that failed to comply with reporting requirements?

b. How much funding did NIH give to the grant recipients that have failed to comply with reporting requirements since 2007?


5. What actions has NIH taken to remove oversight responsibilities from employees who intentionally opted to ignore the enforcement requirements?


6. How will NIH ensure that staff follows their enforcement obligations?


TranspariMED has approached NIH for comment.


Will NIH finally audit its funding portfolio?


Till Bruckner, founder of TranspariMED, said:


“Finally, U.S. policy makers are waking up to the immense cost of research waste in publicly funded clinical trials.”


“TranspariMED looks forward to learning how many NIH-funded trials have failed to comply with federal and NIH reporting requirements since 2007, and what NIH will do to ensure that their results are made publicly available.”


A recently published New Zealand audit checked whether and when publicly funded clinical trials had made their results public, covering all trials funded 1999-2017.


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. One such audit process is described in detail here.


The letter to NIH was sent by Senators Marsha Blackburn, Charles E. Grassley, Ron Johnson, and Roger Marshall. It is available online and can be downloaded below:

Senate letter to NIH 20221013
.pdf
Download PDF • 168KB

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