Conflicts of Interest and Outcomes of Cardiovascular Trials.

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Date

2016-03-01

Authors

Riaz, Haris
Khan, Muhammad Shahzeb
Riaz, Irbaz Bin
Raza, Sajjad
Khan, Abdur Rahman
Krasuski, Richard A

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Abstract

Conflicts of interests have long been recognized as potential sources of influence in the conduct and reporting of clinical trials. This controversy was again rekindled after the publication of the latest statin guidelines and a series of studies regarding competing interests in leading medical journals. We investigate the association between declared author conflicts and the outcomes of large cardiovascular trials. We searched the Medline (PubMed) database to identify "phase 2" and "phase 3" clinical trials using the search term "cardiovascular" over the past decade using "10 years" as the filter. We perceived the competing interest as present regardless of the nature such as consulting fees, honoraria, travel imbursements, stock holding, and employment. Of the 699 titles retrieved, 114 studies met the inclusion criteria. Nearly 80% of studies had at least a single author with competing interests. The 114 studies had a total of 1,433 investigators, of which 725 had declared conflicts of interests (50.6%). A total of 66 studies (58%) had half or >50 percent of investigators who had some conflicts of interests. Of these studies, 54 studies had favorable outcomes and only 12 had unfavorable outcomes (p <0.001). Among the type of competing interests, consulting or personal fees was the most common present in 58 investigators (51%). This was followed by research grants present in 55 the researchers (48%). Among 25 (22%) studies, at least one investigator reported stakes in the industry, of which only 2 studies had unfavorable outcomes for the intervention being investigated. Just 1 of the 25 clinical trials with a sample size of >1,000 had no investigators with competing interests. In conclusion, authors conflicts are associated with favorable outcomes in cardiovascular outcome trials.

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Biomedical Research, Cardiovascular Diseases, Clinical Trials as Topic, Conflict of Interest, Humans, Periodicals as Topic

Citation

Published Version (Please cite this version)

10.1016/j.amjcard.2015.12.011

Publication Info

Riaz, Haris, Muhammad Shahzeb Khan, Irbaz Bin Riaz, Sajjad Raza, Abdur Rahman Khan and Richard A Krasuski (2016). Conflicts of Interest and Outcomes of Cardiovascular Trials. Am J Cardiol, 117(5). pp. 858–860. 10.1016/j.amjcard.2015.12.011 Retrieved from https://hdl.handle.net/10161/11670.

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Scholars@Duke

Krasuski

Richard Andrew Krasuski

Professor of Medicine

Dr. Richard Krasuski is Director of the Adult Congenital Heart Center at Duke University Medical Center, the Director of Hemodynamic Research, and the Medical Director of the CTEPH Program. He is considered a thought leader in the fields of pulmonary hypertension and congenital heart disease. His research focus is in epidemiologic and clinical studies involving patients with pulmonary hypertension and patients with congenital heart disease. He is involved in multiple multicenter studies through the Alliance for Adult Research in Congenital Cardiology (AARCC). He has also helped to develop multiple research databases in these patient populations. He is Co-PI in the upcoming EPIPHANY Study examining the impact of medical and transcatheter interventions on RV-PA coupling in patients with chronic thromboembolic pulmonary hypertension. Over his career he has mentored over 80 students, residents and fellows and has published over 300 peer reviewed publications, book chapters and meeting abstracts. He is also the Chief Editor of Advances in Pulmonary Hypertension and on the editorial boards of several leading medical journals.


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