OIG reprimands NIH for not enforcing trial transparency requirements
Regulatory News | 18 August 2022 |
(Source: Pexels)
The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) says the National Institutes of Health (NIH) has failed to hold NIH-funded researchers accountable for publishing clinical trial data. The watchdog agency has made several recommendations to ensure better transparency in the future.
The OIG published a report on 12 August criticizing the NIH for not fully enforcing federal reporting requirements for intramural and extramural studies that it funds.
By law, NIH-funded researchers are supposed to publish their results on ClinicalTrials.gov but the OIG found about half of them were failing to do so on time and one-third of them weren’t publishing their results at all. More specifically, when the watchdog agency reviewed NIH-funded research that was supposed to be published on ClinicalTrials.gov in 2019 and 2020, of the 72 clinical trials it reviewed, only 35 were published on time, 12 were published late and 25 were never published.
“Posting the results of clinical trials on ClinicalTrials.gov provides the public information that is available for understanding the safety and effectiveness of interventions,” the OIG report states. “We conducted this audit because our preliminary review of data from ClinicalTrials.gov showed that the results of most NIH-funded clinical trials that were completed in calendar year 2018 were not posted.”
“The noncompliance with federal reporting requirements occurred because NIH did not have adequate procedures for ensuring that responsible parties submitted the results of clinical trials, took limited enforcement action when there was noncompliance, and continued to fund new research of responsible parties that had not submitted the results of their completed clinical trials,” the agency added.
The OIG says that while the NIH’s Office of Protocol Services within the Office of Intramural Research has procedures in place to send notification letters to responsible parties to remind them that they are required to submit the results of their trials on time, the notifications alone were not effective.
Many of the researchers reported having challenges submitting their results on ClinicalTrials.gov. Those challenges included figuring out how to report results using the system. Some also complained that the system for uploading the results is not user-friendly and data fields are often overwritten when additional data is uploaded.
“The results of clinical trials, whether positive or negative, improve the design of future research and ultimately advance the development of clinical interventions,” the OIG said. “When the results of clinical trials are not submitted to ClinicalTrials.gov in a timely manner, information about those results, including information on adverse events that occurred during the clinical trials, is not available to health care providers, patients, or researchers.”
In a letter to the watchdog agency, NIH said it agreed with the OIG report and has already begun to implement some of the recommendations to improve the website and its procedures as recommended, including updating ClinicalTrials.gov to make it easier to submit data and working with researchers to make it more user-friendly. They will also hold back future funding unless researchers comply with their reporting requirements.
The NIH says the National Library of Medicine which manages ClinicalTrials.gov has already taken several steps to improve the site’s user interface based on usability studies. The agency says it has already released a beta version of the site after substantial stakeholder input on how to improve the user interface.
“The modernization effort will make the submission of high-quality study information more intuitive, which in tum, will also benefit the end users of the data,” the agency said. “NIH anticipates that the needs of ClinicalTrials.gov user community will continue to evolve with our changing scientific landscape and will continue to work to stay abreast of their needs to make this resource maximally useful.”
The NIH says it will also take certain enforcement actions as recommended by the OIG to get researchers to submit their trial results. It includes improving the website’s alert system to track when researchers are supposed to submit their results and holding back future research funding until the researchers comply with federal reporting requirements.
The OIG published a report on 12 August criticizing the NIH for not fully enforcing federal reporting requirements for intramural and extramural studies that it funds.
By law, NIH-funded researchers are supposed to publish their results on ClinicalTrials.gov but the OIG found about half of them were failing to do so on time and one-third of them weren’t publishing their results at all. More specifically, when the watchdog agency reviewed NIH-funded research that was supposed to be published on ClinicalTrials.gov in 2019 and 2020, of the 72 clinical trials it reviewed, only 35 were published on time, 12 were published late and 25 were never published.
“Posting the results of clinical trials on ClinicalTrials.gov provides the public information that is available for understanding the safety and effectiveness of interventions,” the OIG report states. “We conducted this audit because our preliminary review of data from ClinicalTrials.gov showed that the results of most NIH-funded clinical trials that were completed in calendar year 2018 were not posted.”
“The noncompliance with federal reporting requirements occurred because NIH did not have adequate procedures for ensuring that responsible parties submitted the results of clinical trials, took limited enforcement action when there was noncompliance, and continued to fund new research of responsible parties that had not submitted the results of their completed clinical trials,” the agency added.
The OIG says that while the NIH’s Office of Protocol Services within the Office of Intramural Research has procedures in place to send notification letters to responsible parties to remind them that they are required to submit the results of their trials on time, the notifications alone were not effective.
Many of the researchers reported having challenges submitting their results on ClinicalTrials.gov. Those challenges included figuring out how to report results using the system. Some also complained that the system for uploading the results is not user-friendly and data fields are often overwritten when additional data is uploaded.
“The results of clinical trials, whether positive or negative, improve the design of future research and ultimately advance the development of clinical interventions,” the OIG said. “When the results of clinical trials are not submitted to ClinicalTrials.gov in a timely manner, information about those results, including information on adverse events that occurred during the clinical trials, is not available to health care providers, patients, or researchers.”
In a letter to the watchdog agency, NIH said it agreed with the OIG report and has already begun to implement some of the recommendations to improve the website and its procedures as recommended, including updating ClinicalTrials.gov to make it easier to submit data and working with researchers to make it more user-friendly. They will also hold back future funding unless researchers comply with their reporting requirements.
The NIH says the National Library of Medicine which manages ClinicalTrials.gov has already taken several steps to improve the site’s user interface based on usability studies. The agency says it has already released a beta version of the site after substantial stakeholder input on how to improve the user interface.
“The modernization effort will make the submission of high-quality study information more intuitive, which in tum, will also benefit the end users of the data,” the agency said. “NIH anticipates that the needs of ClinicalTrials.gov user community will continue to evolve with our changing scientific landscape and will continue to work to stay abreast of their needs to make this resource maximally useful.”
The NIH says it will also take certain enforcement actions as recommended by the OIG to get researchers to submit their trial results. It includes improving the website’s alert system to track when researchers are supposed to submit their results and holding back future research funding until the researchers comply with federal reporting requirements.
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