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Comment & Response |

Risk Profile of Clinical Trial Participants

William J. Kostis, MD, PhD1; Sri Ram Pentakota, MD, MPH, PhD2; Abel E. Morerya, MD2
[+] Author Affiliations
1Cardiology Division, Massachusetts General Hospital, Boston
2Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
JAMA. 2015;313(1):93-94. doi:10.1001/jama.2014.15630.
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To the Editor In their research letter, Dr Udell and colleagues1 stated that clinical trial participants had a lower risk profile and a more favorable prognosis compared with the broader population included in the National Cardiovascular Data Registry (NCDR) Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With The Guidelines.

It is likely that these differences would be more pronounced if clinical trial participants were compared with patients with myocardial infarction in the broader US population because participation in the NCDR is voluntary and includes participation by only 5% of US hospitals.1,2 In addition, the data would be put in better perspective if the age of the patients with myocardial infarction in the NCDR and the rates of diagnostic cardiac catheterization and percutaneous coronary intervention were compared with a more inclusive database such as the Nationwide Inpatient Sample.2


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January 6, 2015
Jacob A. Udell, MD, MPH; Matthew T. Roe, MD, MHS; Stephen D. Wiviott, MD
1Women’s College Hospital, University of Toronto, Toronto, Ontario, Canada
2Duke Clinical Research Institute, Duke University, Durham, North Carolina
3Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts
JAMA. 2015;313(1):94-95. doi:10.1001/jama.2014.15633.
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