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.


METHODS
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.


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.
Weinfurt
Kevin P
KP
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, PO Box 17969, Durham, NC 27715, USA. kevin.weinfurt@duke.edu
Hall
Mark A
MA
Hardy
N Chantelle
NC
Friedman
Joëlle Y
JY
Schulman
Kevin A
KA
Sugarman
Jeremy
J
D000046:Academic Medical Centers / Q000191:economics* / Q000941:ethics; D035843:Biomedical Research / Q000191:economics* / Q000941:ethics; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics; D017326:Clinical Trials, Phase III as Topic / Q000191:economics* / Q000941:ethics; D016265:Conflict of Interest / Q000191:economics*; D028744:Ethics Committees, Research / Q000191:economics / Q000941:ethics; D006801:Humans