The generalizability of NCI-sponsored clinical trials accrual among women with gynecologic malignancies - Gynecologic Oncology
Published online: September 30, 2016
Highlights
- •The population enrolled to gynecologic cancer clinical trials differs from the US population.
- •Extremes of age, racial and ethnic minorities in are under-represented in these clinical trials.
- •Several factors including geography influence the diversity of clinical trials accruals.
Objectives
Enrollment
of a representative population to cancer clinical trials ensures
scientific reliability and generalizability of results. This study
evaluated the similarity of patients enrolled in NCI-supported group
gynecologic cancer trials to the incident US population.
Methods
Accrual
to NCI-sponsored ovarian, uterine, and cervical cancer treatment trials
between 2003 and 2012 were examined. Race, ethnicity, age, and
insurance status were compared to the analogous US patient population
estimated using adjusted SEER incidence data.
Results
There
were 18,913 accruals to 156 NCI-sponsored gynecologic cancer treatment
trials, ovarian (56%), uterine (32%), and cervical cancers (12%).
Ovarian cancer trials included the least racial, ethnic and age
diversity. Black women were notably underrepresented in ovarian trials
(4% versus 11%). Hispanic patients were underrepresented in ovarian and
uterine trials (4% and 5% versus 18% and 19%, respectively), but not in
cervical cancer trials (14 versus 11%). Elderly patients were
underrepresented in each disease area, with the greatest
underrepresentation seen in ovarian cancer patients over the age of 75
(7% versus 29%). Privately insured women were overrepresented among
accrued ovarian cancer patients (87% versus 76%), and the uninsured were
overrepresented among women with uterine or cervical cancers. These
patterns did not change over time.
Conclusions
Several
notable differences were observed between the patients accrued to NCI
funded trials and the incident population. Improving representation of
racial and ethnic minorities and elderly patients on cancer clinical
trials continues to be a challenge and priority.
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