When FDA inspections of clinical trials discover actionable research misconduct, how is the public notified? It isn’t / JAMA IM

 2015 Apr 1;175(4):567-77. doi: 10.1001/jamainternmed.2014.7774.


Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature.

Seife C1.

Abstract


IMPORTANCE:

Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.


OBJECTIVES:

To identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.


DESIGN AND SETTING:

Cross-sectional analysis of publicly available documents, dated from January 1, 1998, to September 30, 2013, describing FDA inspections of clinical trial sites in which significant evidence of objectionable conditions or practices was found.


MAIN OUTCOMES AND MEASURES:

For each inspection document that could be linked to a specific published clinical trial, the main measure was a yes/no determination of whether there was mention in the peer-reviewed literature of problems the FDA had identified.


RESULTS:

Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate record-keeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.


CONCLUSIONS AND RELEVANCE:

When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.

Similar Posts

FDA promised very extensive surveillance for adverse effects of Covid vaccines–presentation to FDA VRBPAC Advisory Committee, October 22, 2020

https://www.fda.gov/media/143557/download It should be apparent that FDA was aware by October 22, 2020 of many of the side effects of Covid vaccines that the public only learned about later.  It should also be apparent that FDA (and CDC has access to even more methods for surveillance) has many databases to learn about vaccine safety–whose data…

Why don’t they like the name Moneypock$ ?

And why would Tedros declare a Public Health Emergency of international Concern (PHEIC) for moneypox?  Because $money [pox] talks, and that declaration enables WHO to call for more funding.   Turns out that the first PHEIC was declared in 2009 for the low severity swine flu epidemic. PHEICs were first defined in the International Health Regulations,…

Measles: two US outbreaks are blamed on low vaccination rates. Another perspective

My 2019 published letter to the BMJ (formerly British Medical Journal):  BMJ 2019;364:l312 Measles: two US outbreaks are blamed on low vaccination rates. Another perspective Please allow me to make a few corrections and add context to Ms. Tanne’s article. Endemic measles has been eradicated from the US and the whole of the western hemisphere, per…

Newest method to confuse the public: are boosters needed or not? No, but they will be here soon regardless, garbed in The Science, of course

To all appearances, the CNN story below concerns a duel between Pharma Giant Pfizer, which wants to sell new vaccine for variants, and 3 federal agencies, who say we don’t think they are needed yet and we will determine with the SCIENCE when they will be needed.  Sounds good.  For once the feds are speaking…

If the vaccines are effective, how long do they work?/ MedPageToday

From MedPageToday:  Maybe you will need those 6-monthly boosters Netanyahu promised if you lack natural immunity… “neutralizing activity in the older groups declined approximately 10-fold at 6 months from the peak 14 days after the second vaccine dose; in those 18-55, activity was down by roughly half. But activity levels in the older groups remained…