OFFICE OF INSPECTOR GENERAL: 'The NIH under Dr. Francis Collins Did Not Ensure That All Clinical Trial Results Were Reported in Accordance With Federal Requirements'; see how to get FREE gifted book
by Paul Alexander
Specifically, responsible parties for the 37 clinical trials that did not comply with Federal reporting requirements either did not submit their results (5 Intramural-funded and 20 Extramural-funded)
We need specific details on which studies were directly linked to COVID investigations.
‘NIH did not ensure that all NIH-funded Intramural and Extramural clinical trials complied with Federal reporting requirements for responsible parties to submit the results of clinical trials to ClinicalTrials.gov. Of the 72 NIH-funded clinical trials we reviewed, NIH ensured that responsible parties associated with 35 clinical trials (20 Intramural-funded and 15 Extramuralfunded) complied with Federal reporting requirements.
However, NIH did not ensure that responsible parties associated with 37 clinical trials (16 Intramural-funded and 21 Extramuralfunded) complied with Federal reporting requirements. Specifically, responsible parties for the 37 clinical trials that did not comply with Federal reporting requirements either did not submit their results (5 Intramural-funded and 20 Extramural-funded) or submitted them late (11 Intramural-funded and 1 Extramural-funded).
NIH complied with the Federal reporting requirement to post clinical trial results to ClinicalTrials.gov within 30 days of the submission date for the 47 NIH-funded clinical trials in which responsible parties submitted their results (35 submitted on time and 12 submitted late). NIH posted these results in an average of 14 days. NIH was not able to post the results of the remaining 25 clinical trials because the results were not submitted by the responsible parties. 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.
NIH officials explained that they were aware that some responsible parties faced challenges with submitting the results of their clinical trials to ClinicalTrials.gov. The NIH Office of Intramural Research began analyzing its procedures during our audit and drafted a new chapter for the NIH Policy Manual, Chapter 3007, Clinical Trials Registration and Results Information Reporting (Chapter 3007), related to the Intramural Research Program. The new chapter was finalized in January 2022 and designed to improve responsible parties’ compliance with clinical trial registration and results information reporting.12 The chapter defines the roles and responsibilities of key officials and includes the consequences responsible parties face when they do not comply.’
Substack on how to get the FREE book, ‘Presidential Takedown’: