NIH crack down: report your clinical trial results or face sanctions

The world’s largest medical research funder has warned grantees to rapidly make public the results of their clinical trials or face sanctions. NIH's new “internal controls” have already succeeded in nearly doubling trial reporting speeds.

The National Institutes of Health (NIH) just told grantees that:

“We are committed to taking this challenge head on. Moving forward, you will see increased communication from us and, if needed, enforcement actions to get us to where we need to be.”

A long-standing NIH policy requires grantees to upload the results of all NIH-funded clinical trials onto the ClinicalTrials.gov registry within a year of a trial’s primary completion date. However, NIH for many years failed to monitor or enforce compliance, so many institutions ignored the rule.

During 2017-2019 alone, the results of 200 NIH-funded clinical trials involving over 40,000 children ended up as research waste because their results were never made public. Those trials were connected to NIH grants totalling $362 million.

Things started changing in August 2022, when the Office of the Inspector General found that most results were being reported late or not at all. Two months later, NIH received a letter from four Republican senators urging action, followed by a separate letter from a Democratic congressman early this year. A petition recently filed by Universities Allied for Essential Medicines added to the pressure on NIH to act.

On Friday, NIH released monitoring data showing that its efforts to chase up missing results have already had a dramatic impact. Between 2020 and 2022, the median time between trial completion and results publication accelerated from 740 days to 400 days.

In 2020, only 29% of trial results were made public within a year. Two years later, that figure had already increased to 41%.

Noting that “we still need to improve,” NIH called on institutions to ensure that investigators comply with the rules:

Source: NIH website

Till Bruckner, founder of TranspariMED, said:

“It is fantastic that NIH are finally cracking down on research waste and speeding up the publication of trial results. This is a big win for patients, a big win for taxpayers, and a big win for science.”

“Hopefully, NIH will next go through its records and chase up every single trial result that has gone missing in the past, to prevent data from tens of thousands of patients from becoming lost forever. Sending out reminder emails is far cheaper than having to fund the same trial twice.”

Funders in Europe, Canada and New Zealand have also started cracking down on research waste in recent months.

What’s next?

TranspariMED is currently:

• Assessing the policies and monitoring systems of 34 research funders worldwide

• Pushing the FDA to finally enforce a 2007 trial reporting law

• Campaigning to end research waste in Germany

• Chasing up 1,000 missing trial results in the UK

Please support our work to help us keep up the good fight.