The world’s largest medical research funder has blocked two researchers from launching new projects after they violated NIH policies on clinical trial reporting.
Unreported results from clinical trials are a significant concern. They are wasteful, can result in unnecessary repeating of trials and may result in clinicians making dangerous choices about treatment. The United States has had rules and laws about the mandatory reporting of trial results for some time. To this point, these are standards that have not obviously been enforced. So, it is excellent to see the NIH taking this stance. Hopefully, it will prompt more clinical researchers and trial sponsors reporting results.
“Results had not been reported within 1 year of the primary completion date, as required by the NIH 2016 dissemination policy. NIH officials told us the principal investigators of these two trials reported trials results on ClinicalTrials.gov after NIH had withheld approval of new research.”
Both individuals were working as intramural researchers within an NIH-affiliated institute.
Annual NIH trials budget: $5 billion
Every year, the NIH spends more than $5 billion of taxpayers’ money on clinical trials. In the past, much of that money was wasted because trial results were not made public.
Most of the NIH trials budget – approximately $4 billion – is disbursed to universities andfor-profit companies in the form of research grants. The remaining $1 billion is spent onintramural research.
According to the report:
“NIH funded over 9,000 grants supporting clinical trials that tested drugs and otherinterventions in fiscal year 2021… For fiscal years 2017 through 2021, NIH reported that it obligated… $28 billion for clinical trials… We found that the numberof NIH-funded clinical trials registered on ClinicalTrials.gov in each fiscal year from2019 through 2022 ranged from 1,385 to 1,485.”