title: Factors influencing inclusion in digestive cancer clinical trials: A population-based study.
abstract: BACKGROUND
  Inclusion in a randomized therapeutic trial represents an optimal therapeutic strategy.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  The relationship between type of institution and deprivation underlines the necessity for improving patients' chance of being recruited in digestive cancer clinical trials.
authors.affiliation: Dijon University Hospital, Digestive Cancer Registry of Burgundy, Dijon, France; INSERM, U866, Dijon, France.
authors.forename: Mathilde
authors.initials: M
authors.lastname: Frérot
authors.affiliation: Dijon University Hospital, Digestive Cancer Registry of Burgundy, Dijon, France; INSERM, U866, Dijon, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Jooste
authors.affiliation: 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.
authors.forename: Christine
authors.initials: C
authors.lastname: Binquet
authors.affiliation: 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.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Fournel
authors.affiliation: Dijon University Hospital, Digestive Cancer Registry of Burgundy, Dijon, France; INSERM, U866, Dijon, France; University Hospital, Hepato-Gastroenterology Department, Dijon, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
authors.affiliation: Dijon University Hospital, Digestive Cancer Registry of Burgundy, Dijon, France; INSERM, U866, Dijon, France. Electronic address: anne-marie.bouvier@u-bourgogne.fr.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Bouvier
mesh_terms: D000367:Age Factors; D002986:Clinical Trials as Topic / Q000592:standards*; D005770:Gastrointestinal Neoplasms / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D016015:Logistic Models; D015999:Multivariate Analysis; D018579:Patient Selection; D012042:Registries; D012959:Socioeconomic Factors
keywords: Clinical trial; Digestive cancers; Registries; Socio-economic factors