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Identification of Cancer Care and Protocol Characteristics Associated With Recruitment in Breast Cancer Clinical Trials

Julie Lemieux, Pamela J. Goodwin, Kathleen I. Pritchard, Karen A. Gelmon, Louise J. Bordeleau, Thierry Duchesne, Stéphanie Camden, Caroline H. Speers

From the Unité de Recherche en Santé des Populations, Centre des Maladies du Sein Deschênes-Fabia, Hôpital St-Sacrement, and Centre d’Hématologie, Centre Hospitalier Affilié Universitaire de Québec; Département de Médecine and Mathématiques et de Statistique, Université Laval, Québec, Québec; Samuel Lunenfeld Research Institute of the Mount Sinai Hospital; Department of Medicine, University of Toronto; Sunnybrook Health Sciences Centre, Toronto, Ontario; British Columbia Cancer Agency; and Breast Cancer Outcomes Unit, Vancouver, British Columbia, Canada

Corresponding author: Julie Lemieux, MD, MSc, FRCPC, Unité de Recherché en Santé des Populations, Hôpital St-Sacrement du Centre Hospitalier Affilié Universitaire de Québec, 1050 Chemin Sainte-Foy, Québec, QC, Canada G1S 4L8; e-mail: julie.lemieux{at}uresp.ulaval.ca

Purpose It is estimated that only 5% of patients with cancer participate in a clinical trial. Barriers to participation may relate to available protocols, physicians, and patients, but few data exist on barriers related to cancer care environments and protocol characteristics.

Methods The primary objective was to identify characteristics of cancer care environments and clinical trial protocols associated with a low recruitment into breast cancer clinical trials. Secondary objectives were to determine yearly recruitment fraction onto clinical trials from 1997 to 2002 in Ontario, Canada, and to compare recruitment fraction among years. Questionnaires were sent to hospitals requesting characteristics of cancer care environments and to cooperative groups/pharmaceutical companies for information on protocols and the number of patients recruited per hospital/year. Poisson regression was used to estimate the recruitment fraction.

Results Questionnaire completion rate varied between 69% and 100%. Recruitment fraction varied between 5.4% and 8.5% according to year. More than 30% of patients were diagnosed in hospitals with no available trials. In multivariate analysis, the following characteristics were associated with recruitment: use of placebo versus not (relative risk [RR] = 0.80; P = .05), nonmetastatic versus metastatic trial (RR = 2.80; P < .01), and for nonmetastatic trials, protocol allowing an interval of 12 weeks or longer versus less than 12 weeks (from diagnosis, surgery, or end of therapy) before enrollment (RR = 1.36; P < .01).

Conclusion Allowable interval of 12 weeks or longer to randomly assign patients in clinical trials could help recruitment. In our study, absence of an available clinical trial represented the largest barrier to recruitment.

Supported by the Canadian Breast Cancer Foundation–Ontario Chapter.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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