Washington, D.C.--(Newsfile Corp. - September 14, 2022) - The National Institute of Health (NIH) has been reprimanded by the US Department of Health and Human Services (HHS) for failing to uphold transparency guideline requirements, according to a recent statement from the Office of the Inspector General (OIG). With more than half of studies not submitted or submitted late, failure to report findings and research for NIH-funded projects on ClinicalTrials.gov is a violation of the law. The HHS and OIG have made recommendations to the NIH to ensure transparency moving forward.
Published earlier this month by the OIG, the statement outlined specifics on the reprimand and mistakes the NIH made in inadequately enforcing federal reporting requirements for the various studies that it funds. The results of these trials, when funded by the NIH, are cataloged to inform researchers in future decisions on whether findings were favorable or unfavorable. Clinical trials strategist, Dr. Deepak Patil, discusses implications of research results sharing on drug development.
Of research studies funded by the NIH in 2019 and 2020, 51% of the results were either never published online or published late. By posting these results to ClinicalTrials.gov, the program provides the public with immediate access to information received through research, the Office of the Inspector General's report stated. The report went on to say that the audit was conducted because the initial observation of the data yielded from ClinicalTrials.gov did not reflect numbers as many studies conducted in 2018 were not posted to the site.
"Learning from NIH-funded intramural and extramural research plays a significant role in furthering the life sciences industry's R&D projects. Failing to share findings of research leads to duplication of efforts and significant wastage of resources," says Dr. Deepak Patil.
In response to this report, the NIH has agreed to update procedures to ensure strict implementation of guidelines. ClinicalTrials.gov is also receiving an update to allow researchers to more effectively utilize the interface to publish results. The NIH is also now holding back funding from any projects unless research meets requirements.
ClinicalTrials.gov has received complaints from researchers, prior to the NIH further streamlining the site. Reporting results using the system has proven difficult for many researchers, and some even complained that the system for uploading the results is often overwritten when additional data is uploaded. Dr. Patil comments on changes to make ClinicalTrials.gov more intuitive, "Better design and user-friendliness of ClinicalTrials.gov should not only help researchers submit results of research in a streamlined manner, but also make the information easier to access and understand for patients and caregivers."
The OIG also determined that reminders and notification letters sent by the NIH's Office of Protocol Services within the Office of Intramural Research to responsible parties to ensure deadlines are enforced were insufficient in upholding the standards of the organization. The NIH has pledged to integrate these crucial changes to ensure data is as accessible as possible to both academics in the medical field and average Americans hoping to learn about an experimental procedure that may still be undergoing research.
Knowledge sharing among publicly funded, private and public-private partnerships is extremely valuable to drive efficiencies in clinical as well. "In addition to NIH funded research, knowledge sharing among privately funded researchers to further discovery and development of new treatment options for patients. Patient advocacy associations are leading the charge to design and implement research consortiums around specific diseases to incentivize knowledge sharing," Dr. Patil says.
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