Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings.

BACKGROUND: Studies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings. OBJECTIVE: To compare oversight and management of investigators' financial relationships in academic and nonacademic research settings. DESIGN, SETTING, AND PARTICIPANTS: Survey of officials at 199 sites that contributed participants to commercially sponsored phase 3 clinical trials published in JAMA or the New England Journal of Medicine in 2006 and 2007. MEASUREMENTS AND MAIN RESULTS: Response rates were 66% for academic medical centers, 37% for nonacademic medical centers (inpatient), and 27% for outpatient nonacademic sites. Almost all academic medical centers (97%) and most nonacademic medical centers (87%) followed written conflict-of-interest policies, whereas 44% of outpatient nonacademic sites had written policies (P < 0.001). Academic and nonacademic medical centers relied mainly on internal institutional review boards (69% and 71%, respectively); outpatient nonacademic sites relied primarily on independent institutional review boards (59%; P < 0.001). CONCLUSIONS: Nonacademic sites have substantially different approaches to the oversight and management of financial relationships in commercially sponsored clinical research than academic medical centers. These differences warrant more attention to how financial relationships are monitored in community research settings.

Duke Scholars

Author Kevin Phillip Weinfurt Population Health Sciences