title: The bottleneck effect in lung cancer clinical trials.
abstract: Clinical trials provide the most promising way to improve treatment outcomes in cancer. This study examined the rate at which eligible patients with lung cancer, at a National Cancer Institute-designated cancer center in the South, were offered a clinical trial and explored for reasons for ineligibility. We retrospectively reviewed 300 randomly selected lung cancer patients' medical records seen in 2010, to assess clinical trial offers to eligible patients, reasons for not offering an eligible patient a trial, demographic factors associated with eligibility, and reasons for refusal among those offered a trial. Of the 300 patient charts, seven were excluded for lack of confirmed lung cancer diagnosis. Forty-six of the remaining 293 (15.7%) patients were eligible for a clinical trial. Forty-five of the 46 (97.8%) were considered for a trial by their oncologist. Thirty-five of the 45 (77.8%) were offered a trial: 15 agreed (42.9% of those offered, 5.1% of patients reviewed), 11 declined, and 9 were undecided at the end of the review window. Patients with poor Eastern Cooperative Oncology Group (ECOG) performance status levels and small cell (SC) diagnoses were significantly less likely to be eligible for a trial. Results suggest that oncologists at the cancer center are effectively presenting all eligible patients with the option of a clinical trial; however, there is a need to increase the number of approved clinical trials for patients with SC or ECOG score greater than 2.
authors.affiliation: Department of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA.
authors.forename: Luis E
authors.initials: LE
authors.lastname: Gonzalez
authors.forename: Steven K
authors.initials: SK
authors.lastname: Sutton
authors.forename: Christie
authors.initials: C
authors.lastname: Pratt
authors.forename: Matthew
authors.initials: M
authors.lastname: Gilbertson
authors.forename: Scott
authors.initials: S
authors.lastname: Antonia
authors.forename: Gwendolyn P
authors.initials: GP
authors.lastname: Quinn
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000628:therapy; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D015897:Comorbidity; D004608:Eligibility Determination; D005260:Female; D005500:Follow-Up Studies; D006297:Health Services Accessibility; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection; D011379:Prognosis; D035842:Research Subjects / Q000600:supply & distribution*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D055752:Small Cell Lung Carcinoma / Q000175:diagnosis / Q000628:therapy; D016312:Treatment Refusal