We have an update on the case of Parag Patel, the Park Ridge, Illinois cardiologist whom the Office of Research Integrity (ORI) said “engaged in research misconduct by directing or intimidating fellows and others to influence” test results so that patients would be eligible for a clinical trial.
A spokesperson for the clinical trial’s sponsor, the University of California, San Francisco (UCSF), tells us:
…the UCSF Institutional Review Board, as well as the independent Data Safety Monitoring Board for the study, will be reviewing the matter and making recommendations that might affect inclusion of data in the study. The number of patients enrolled from the Park Ridge site is a small fraction of the total participants enrolled to date.
More on the trial, from our Tuesday post:
The VEST trial “explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias,” according to its entry in ClinicalTrials.gov. It began recruiting 1,900 participants in 2008, and is expected to be complete in 2015.
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From 79 FR 15127 :
“ORI and Advocate Health Care found that the Respondent engaged in research misconduct by directing or intimidating fellows and others to influence left ventricular ejection fraction (LVEF)scores of ≤ 35% and requesting attending physicians to reassess scores of LVEF to be reported as ≤ 35% for research subjects after being diagnosed with acute myocardial infarction, thereby causing and being responsible for falsification of research records. These falsifications made subjects eligible for enrollment into the “Vest Prevention of Early Sudden Death Trial” (VEST) when they otherwise may not have been eligible.”
So the intent was to pump up his enrollment by allowing more people in despite exclusion criteria?
According to clinicaltrials.gov (NCT00628966) the partner was Zoll Medical Corporation (http://www.lifevest.zoll.com/). Not sure if they would want go to deeper into the risk pool than necessary. Wonder what they thought of the PI’s scheme.
” will be reviewing the matter and making recommendations that might affect inclusion of data in the study.”
Does this mean they will recommend to exclude data acquired from Parag Patel? Could someone please explain?
Have a look at, another case from the year 2004 at Lutheran General:
http://www.fda.gov/iceci/enforcementactions/warningletters/2004/ucm146903.htm
I would assume that they mean that cases will be screened for appropriate compliance with inclusion / exclusion criteria. If they do not comply, they would be excluded. I would note this on the CONSORT diagram, but it is not unknown.