Differences in clinical trial patient attributes and outcomes according to enrollment setting.
OBJECTIVE
During the last 25 years, National Cancer Institute (NCI) cooperative trial groups have extended trial networks from academic centers to include certain community and Veterans Health Administration (VHA) centers. We compared trial patients' attributes and outcomes by these enrollment settings.


METHODS
Studying 2,708 patients on one of 10 cooperative group, randomized lung trials at 272 institutions, we compared patient attributes by enrollment setting (ie, academic, community, and VHA affiliates). We used adjusted Cox regression to evaluate for survival differences by setting.


RESULTS
Main member institutions enrolled 44% of patients; community affiliates enrolled 44%; and VHAs enrolled 12%. Patient attributes (ie, case-mix) of age, ethnicity, sex, and performance status varied by enrollment setting. After analysis was adjusted for patient case-mix, no mortality differences by enrollment setting were noted.


CONCLUSIONS
Although trial patients with primarily advanced-stage lung cancer from nonacademic centers were older and had worse performance statuses than those from academic centers, survival did not differ by enrollment setting after analysis accounted for patient heterogeneity. An answer for whether long-term outcomes for patients at community and VHA centers affiliated with cooperative trial groups are equivalent to those at academic centers when care is delivered through NCI trials requires additional research among patients with longer survival horizons.
Lamont
Elizabeth B
EB
Dept of Health Care Policy, Harvard Medical School, 180A Longwood Ave, Boston, MA 02115, USA. lamont@hcp.med.harvard.edu
Landrum
Mary Beth
MB
Keating
Nancy L
NL
Archer
Laura
L
Lan
Lan
L
Strauss
Gary M
GM
Lilenbaum
Rogerio
R
Niell
Harvey B
HB
Maurer
L Herbert
LH
Kosty
Michael P
MP
Miller
Antonius A
AA
Clamon
Gerald H
GH
Elias
Anthony D
AD
McClay
Edward F
EF
Vokes
Everett E
EE
McNeil
Barbara J
BJ
D000046:Academic Medical Centers; D002986:Clinical Trials as Topic; D003153:Community Health Services; D006268:Health Facilities; D006787:Hospitals, Veterans; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D005791:Patient Care / Q000592:standards*; D018579:Patient Selection; D011787:Quality of Health Care; D016896:Treatment Outcome