Clinical trial results made public: The National Institutes of Health began taking action against academic institutions that did not comply with reporting requirements

In recent weeks, the National Institutes of Health (NIH) has begun sending emails
to academic institutions that fail to submit clinical trial results to government databases.

The Clinical Trials Registry and Results Reporting Working Group said that as of this week, the NIH More than two dozen agencies
have been contacted.
The task force is a national coalition of academic medical centers, universities, hospitals, and nonprofits focused on transparency
in clinical trials.
The working group is currently surveying its members to identify the NIH The scope of the
message sent.

Examples of these emails include an October 19 letter from the NIH to a researcher at Johns Hopkins University stating that his institution must publish the results of a clinical trial funded by the
NIH.
NIH The letter makes it clear that the university has 30 days to provide evidence that the results have been published to the ClinicalTrials.
gov or to explain why this
is not required.

The emails come after federal watchdogs heavily criticized NIH for poor public oversight of results from government-funded clinical trials Action
taken.
Two months ago, a report released by the Office of the Inspector General (OIG) of the U.
S.
Department of Health and Human Services (HHS) found that for about half of the clinical trials funded by the NIH, including those funded by the NIH Trials performed by own scientists and outside researchers), which failed to ensure that investigators reported the results of
these trials on ClinicalTrials.
gov within the last two years.

The report highlights issues
with NIH oversight.
Of the 72 NIH-funded trials, only 35 reported results within the last two years of ClinicalTrials.
gov on
.
And the NIH did not ensure the remaining 37 The investigators of the trials complied with the reporting requirements, and the investigators of these trials either did not submit the results at all or submitted the results after the prescribed deadline
.
An in-depth analysis found that 57% of the NIH researchers conducted of studies reported results, 43% did not
.
Overall, studies and unreported proportions conducted by the NIH and external researchers were comparable
.

Moreover, NIH continues to fund new clinical trials
for these researchers who do not report the required results.
Of the 37 researchers who did not comply with the reporting requirements, 21 New NIH-funded clinical trials were initiated before the latest results from previous clinical trials
were submitted to ClinicalTrials.
gov.

OIG The report comes
amid a growing effort to push regulators in the U.
S.
and around the world to increase oversight of transparency in clinical trial results and registrations.
The researchers insist that trial results cannot be easily replicated without specific data, hindering a deeper understanding
of how drugs might work.
The researchers believe this, in turn, could adversely
affect treatment decisions and healthcare costs.

There is no doubt that this OIG report has sparked outrage
.
Under U.
S.
federal law, clinical trials must be within 21 days of enrollment of the first human subject within ClinicalTrials.
gov Register the appropriate study and submit certain summary results information
for the trial, usually no later than one year after the study completion date (unless an additional deadline extension is requested).
However, enforcement and oversight of this legal requirement has been weak
.
OIG The latest report found that federal agencies do not have adequate procedures to achieve the goals
required by law.

In response to the OIG report, the NIH largely agreed with the findings and insisted that it had begun taking steps to improve oversight through additional forms and systems to track and report on researchers
' compliance.
NIH It also said enforcement would be strengthened and no additional funding
would be awarded until reporting requirements were met.

Not only the NIH, but also the FDA has been criticized
for its poor regulation of compliance with clinical trial results reporting.
Last September, the FDA first warned
researchers who failed to report clinical trial results.
Before that, the FDA Two different drugmakers were warned that they failed to publish their findings
.
Warnings from regulators have been effective, with more than 90% according to one report from 2013 to April 2021 of drugmakers and universities quickly submitted information
to the ClinicalTrials.
gov after receiving initial warnings from the FDA that clinical trial results were expired and unpublished.