A prospective study of patient accrual to clinical trials at a NCI-funded Community Clinical Oncology Program
Authors: G. S. Soori, M. B. Wilwerding, M. Carlson, J. Verdirame, P. Townley, M. Hutchins, P. Silberstein, P. McKenna, L. Mahacek, K. Madcharo
Journal: Journal of Clinical Oncology (2008)

9610 Background: Accrual to clinical trials is vital to advance the goals of improving quality of life and survival of all patients with cancer. Current accrual rates remain low and research is needed to explore factors that impede trial accrual so that effective intervention strategies can be developed. This study was undertaken to explore the issues relating to patient accrual and to assess the results of a program implemented for prospective screening of patient records to enhance recruitment. Methods: Study Population: Records of cancer patients at study sites were prospectively screened by CRAs and research RNs for participation in clinical trials during the study period from June 2006 to July 2007. Potential trial participants were further evaluated for eligibility and informed consents were obtained. The data on screening process, factors which impede clinical trial participation and accrual outcomes were recorded. STUDY SITES: Alegent Bergan Mercy Medical Center and Alegent Immanuel Medical Center, in Omaha, LMEP Cancer Resource Center in Lincoln, NE. and affiliated clinics. Results: During a 12 month period, a total of 4,571 patients were screened comprising of 2,902 patients for treatment trials and 1,669 for cancer control trials. Out of these, 127 patients (4.4%) were enrolled in cancer treatment trials and 45patients (2.7%) were enrolled in cancer control trials. Conclusions: Prospective screening of patients for clinical trials will facilitate accrual but the efficiency of accrual however remains low. Lack of available studies and patients failing to fulfill eligibility criteria are critical contributory factors for low accrual rates. Patient and physician refusal are important factors, particularly in treatment trials. Multiple logistical issues also negatively impact accruals. Innovative strategies to enhance accrual and education of patients, health care workers, and the community, both at the local and national levels are vital for better acceptance of clinical trials by patients. Factors for Non-Accrual to Treatment Trials Factors for Non-Accrual to Cancer Control Trials No eligible study 67.7% Patient declined 6.8% Patient declined 7.6% Physician declined 0.9% Physician declined 6.0% Other/Unknown 92.4% Other/Unknown 18.7% Reasons Why Patients Declined Study Reasons Why Physicians Declined to Use a Study Did not like the idea of randomization Increased length of time of treatment Patient too old for the study Frailty and co-morbidities Treatment too aggressive Placebo or observation arm Treatment not aggressive enough Potential for increased side effects Standard of practice better than study treatment Did not want to be a “guinea pig” Extra cost to repeat imaging studies Wanted to start treatment “immediately” Insurance concerns Reluctance to delay treatment Logistical difficulties (travel, compliance, family support) Reluctance to travel a distance Lack of sufficient time to enroll patient Reluctance to repeat scans/tests Availability of competing industry trials Poor communication between research nurse and physician No significant financial relationships to disclose.