ABOVE: The Clinical Center, where the majority of NIH-led clinical trials are performed, at the agency’s main campus in Maryland © Istock.com, Grandbrothers

The US National Institutes of Health failed to ensure the timely reporting of results in roughly half of the clinical trials it funded in 2019 and 2020, including many overseen by NIH scientists, according to the findings of a new report released by the Department of Health and Human Services’ Office of Inspector General. In some cases, the agency allowed researchers who failed to meet these federal reporting requirements to launch new trials as well, drawing intense criticism from research transparency advocates and at least one former director of ClinicalTrials.gov, the federal database in which scientists are legally required to post updates on clinical research.

“NIH has severely let down patients and taxpayers since 2007, when trial reporting first became mandatory,” Till Bruckner, the founder of Transparimed, a group that tracks issues pertaining to clinical trial transparency, tells STAT News. “As this report documents, NIH for over a decade turned a blind eye to violations, and even rewarded law-breakers by handing them even more public money so they could run more trials with more patients.”

In 2018, the US Office of Inspector General (OIG) conducted a small probe to determine whether the NIH—which funds much of the clinical work conducted in the US—was sufficiently enforcing federal regulations that require researchers to publish their results within one year of an estimated or actual completion date. In a brief statement describing its justification for the new report, the OIG stated that “our preliminary review of data from ClinicalTrials.gov showed that most NIH-funded clinical trials that were completed in calendar year 2018 did not have their results posted.” The findings were troubling enough that the office began a more substantive analysis of trials carried out in 2019 and 2020. 

See “Clinical Trial Registry Errors Undermine Transparency

The new report revealed that of the 72 trials analyzed, which included a roughly equal proportion of trials run by NIH scientists and by outside investigators, only 35 studies reported their results within the required timeframe. Of the 37 trials that did not report their results, 43 percent were led by NIH scientists. And at least 21 investigators began a new NIH-funded clinical trial before submitting the late results of their previous clinical trials; Of those, a little less than half were employed by the NIH, while the rest were carried out by outside researchers.

Typically, an office within the NIH sends notices to agency scientists who fail to meet their reporting deadlines. But STAT reports that the same office often failed to follow up with researchers who still didn’t report their findings, and the agency appears to have done little to address complaints by clinicians that the ClinicalTrials.gov database can be difficult to use.

Deborah Zarin, a former director of ClinicalTrials.gov, tells STAT that the persistence of this issue is troubling. The report’s findings come amidst an ongoing push to make trial results more transparent and to hold pharmaceutical companies, universities, and medical centers accountable for meeting their obligations. Zarin says that “in this context, it is disappointing and indeed shocking that NIH continues to emphasize the difficulty of posting results, rather than the scientific value and imperative to do so. I hope that this OIG report is a wake up call to both NIH and the scientific community.”

See “New Automated Tool Monitors Clinical Trial Reporting

In response to the report, the NIH wrote to STAT that it has already begun improving its oversight policies by implementing additional forms and systems for tracking and reporting compliance. Furthermore, no additional grants will be awarded to scientists who fail to meet their reporting requirements until they regain compliance.

A similar shakeup at the Food and Drug Administration (FDA) could serve as a roadmap for the NIH, according to an analysis of FDA-funded clinical trials between 2013 and 2021 published in JAMA last year. After the agency threatened to fine drug companies and principal investigators who failed to report their findings, more than 90 percent of those who received preliminary warnings about overdue clinical trial results quickly provided the information (the median time was just three weeks).

“We know that compliance isn’t impossible. It’s simply not incentivized due to the lack of enforcement,” Navya Dasari, a leader at the Universities Allied for Essential Medicines, an organization that promotes clinical trial disclosure, tells STAT, noting that “to date, the [U.S.] government could have collected over $34 billion in fines to noncompliant sponsors—money that could have been used for public benefit—but has not collected a single cent. We need the NIH and FDA to step up, create an enforcement strategy that prioritizes trials of clinical and societal importance, and take serious action.”