Mathilde Frérot1, Valérie Jooste1, Christine Binquet2, Isabelle Fournel2, Laurent Bedenne3, Anne-Marie Bouvier4. 1. Dijon University Hospital, Digestive Cancer Registry of Burgundy, Dijon, France; INSERM, U866, Dijon, France. 2. INSERM, U866, Dijon, France; INSERM, CIC 1432, Clinical Epidemiology Unit, Dijon, France; Dijon University Hospital, Clinical Investigation Centre, Clinical Epidemiology/Clinical Trials Unit, Dijon, France. 3. Dijon University Hospital, Digestive Cancer Registry of Burgundy, Dijon, France; INSERM, U866, Dijon, France; University Hospital, Hepato-Gastroenterology Department, Dijon, France. 4. Dijon University Hospital, Digestive Cancer Registry of Burgundy, Dijon, France; INSERM, U866, Dijon, France. Electronic address: anne-marie.bouvier@u-bourgogne.fr.
Abstract
BACKGROUND: Inclusion in a randomized therapeutic trial represents an optimal therapeutic strategy. AIMS: To determine the influence of demographic characteristics and deprivation on the enrolment of patients in digestive cancer clinical trials. METHODS: Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed. RESULTS: Patients aged over 75 years were significantly less likely to be included in clinical trials than younger patients (odds ratio 0.33; [0.13-0.87]). Patients treated in private institutions were also less likely to be enrolled than those treated in public institutions (odds ratio 0.04; [0.01-0.16]; p<0.001). A relationship between type of institution and the European deprivation index was observed (p=0.017). Deprived patients were less likely to be included in clinical trials when they were managed in private institutions (odds ratio 0.706; [0.524-0.952]; p=0.022). The European deprivation index had no impact when patients were managed in other institutions. CONCLUSION: The relationship between type of institution and deprivation underlines the necessity for improving patients' chance of being recruited in digestive cancer clinical trials.
BACKGROUND: Inclusion in a randomized therapeutic trial represents an optimal therapeutic strategy. AIMS: To determine the influence of demographic characteristics and deprivation on the enrolment of patients in digestive cancer clinical trials. METHODS: Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed. RESULTS:Patients aged over 75 years were significantly less likely to be included in clinical trials than younger patients (odds ratio 0.33; [0.13-0.87]). Patients treated in private institutions were also less likely to be enrolled than those treated in public institutions (odds ratio 0.04; [0.01-0.16]; p<0.001). A relationship between type of institution and the European deprivation index was observed (p=0.017). Deprived patients were less likely to be included in clinical trials when they were managed in private institutions (odds ratio 0.706; [0.524-0.952]; p=0.022). The European deprivation index had no impact when patients were managed in other institutions. CONCLUSION: The relationship between type of institution and deprivation underlines the necessity for improving patients' chance of being recruited in digestive cancer clinical trials.
Authors: T Aparicio; O Bouché; J Taieb; E Maillard; S Kirscher; P-L Etienne; R Faroux; F Khemissa Akouz; F El Hajbi; C Locher; Y Rinaldi; T Lecomte; S Lavau-Denes; M Baconnier; A Oden-Gangloff; D Genet; E Paillaud; F Retornaz; E François; L Bedenne Journal: Ann Oncol Date: 2018-01-01 Impact factor: 32.976