Carmen E Guerra1,2, Sheila Kelly1, Colleen Redlinger2, Patricia Hernández3, Karen Glanz4,3,5,2. 1. Departments of Medicine. 2. Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA. 3. Perelman School of Medicine. 4. Epidemiology, Biostatistics and Informatics, Perelman School of Medicine. 5. School of Nursing, University of Pennsylvania.
Abstract
OBJECTIVES: Low rates of participation in cancer clinical trials are commonly reported, raising concerns about missed opportunities to engage patients in treatment trials. We reviewed eligibility for and enrollment in pancreatic cancer clinical trials for patients seen at a National Cancer Institute (NCI)-designated cancer center during 1 year, to calculate participation rates with detailed information to determine the best-case participation rate. MATERIALS AND METHODS: This retrospective cohort study used the Abramson Cancer Center Cancer Registry, clinical trial protocols, and electronic medical records (EMRs) to determine eligibility for all available pancreatic cancer clinical trials. Patient characteristics and reasons for ineligibility were abstracted from EMRs. We then computed participation rates based on enrollment in trials using EMR and clinical trials monitoring data. RESULTS: Of 233 new pancreatic cancer patients in 2014, 47 or 20% enrolled in a clinical trial (enrollment fraction). According to the EMR, of the 66 patients who were eligible for a trial, 54 (82% of eligible) accepted and 47 (71% of eligible) ultimately enrolled in a trial, 8 (12% of eligible) declined, and 4 (6% of eligible) had no record of patient decision. Enrollment in a trial by both the EMR and clinical trials database was confirmed for 71% of eligible patients. CONCLUSIONS: This study reveals that 71% of newly diagnosed pancreatic cancer patients who were eligible for a trial were enrolled in a treatment trial. We contend that in-depth analysis, rather than enrollment fraction, should be used to inform the gap between actual participation and optimal clinical trial participation for cancer patients.
OBJECTIVES: Low rates of participation in cancer clinical trials are commonly reported, raising concerns about missed opportunities to engage patients in treatment trials. We reviewed eligibility for and enrollment in pancreatic cancer clinical trials for patients seen at a National Cancer Institute (NCI)-designated cancer center during 1 year, to calculate participation rates with detailed information to determine the best-case participation rate. MATERIALS AND METHODS: This retrospective cohort study used the Abramson Cancer Center Cancer Registry, clinical trial protocols, and electronic medical records (EMRs) to determine eligibility for all available pancreatic cancer clinical trials. Patient characteristics and reasons for ineligibility were abstracted from EMRs. We then computed participation rates based on enrollment in trials using EMR and clinical trials monitoring data. RESULTS: Of 233 new pancreatic cancer patients in 2014, 47 or 20% enrolled in a clinical trial (enrollment fraction). According to the EMR, of the 66 patients who were eligible for a trial, 54 (82% of eligible) accepted and 47 (71% of eligible) ultimately enrolled in a trial, 8 (12% of eligible) declined, and 4 (6% of eligible) had no record of patient decision. Enrollment in a trial by both the EMR and clinical trials database was confirmed for 71% of eligible patients. CONCLUSIONS: This study reveals that 71% of newly diagnosed pancreatic cancer patients who were eligible for a trial were enrolled in a treatment trial. We contend that in-depth analysis, rather than enrollment fraction, should be used to inform the gap between actual participation and optimal clinical trial participation for cancer patients.
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