title: Conflicts of Interest and Outcomes of Cardiovascular Trials.
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.
authors.affiliation: Department of Internal Medicine, Cleveland Clinic, Ohio. Electronic address: riazh@ccf.org.
authors.forename: Haris
authors.initials: H
authors.lastname: Riaz
authors.affiliation: Department of Internal Medicine, Dow University of Health Sciences, Karachi, Pakistan.
authors.forename: Muhammad Shahzeb
authors.initials: MS
authors.lastname: Khan
authors.affiliation: Department of Internal Medicine, University of Arizona, Tucson, Arizona.
authors.forename: Irbaz Bin
authors.initials: IB
authors.lastname: Riaz
authors.affiliation: Department of Cardiac Surgery, Heart and Vascular Institute, Cleveland Clinic, Ohio.
authors.forename: Sajjad
authors.initials: S
authors.lastname: Raza
authors.affiliation: Department of Cardiovascular Medicine, University of Louisville, Louisville, Kentucky.
authors.forename: Abdur Rahman
authors.initials: AR
authors.lastname: Khan
authors.affiliation: Department of Cardiovascular Medicine, Duke University, North Carolina.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Krasuski
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002318:Cardiovascular Diseases / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000941:ethics*; D016265:Conflict of Interest; D006801:Humans; D010506:Periodicals as Topic