title: Inclusion of patients with acute leukemia in clinical trials: a prospective multicenter survey of 1066 cases.
abstract: BACKGROUND
  to estimate the prevalence of adults and children with acute leukemia (AL) included in clinical trials and to determine factors associated with noninclusion.
  
  
  METHODS
  all patients with AL admitted to the 17 departments managing AL in Paris area from 2005 to 2007 were prospectively included. Clinical data, therapeutic decisions, and enrollment in trials were recorded. Reasons that prevented accrual were identified.
  
  
  RESULTS
  a total of 1066 admissions with AL (85% of adults) were recorded, and 34 trials were open. In adults, the rate of inclusion in a trial was 25% [95% confidence interval (CI) 21% to 28%] for acute myeloid leukemia (AML) and 23% (95% CI 17% to 29%) for acute lymphoid leukemia (ALL). In children, the rate of inclusion was 58% (95% CI 41% to 73%) for AML and 64% (95% CI 55% to 72%) for ALL. The rate of inclusion varied across centers, with a significant increase when they were involved in clinical research. Patients included in trials differed significantly from those not included according to age, primary/secondary AL, leukemia type, results of cytogenetic analyses, and stage of disease.
  
  
  CONCLUSIONS
  the rate of inclusion is higher than in oncology. This difference may be explained by management in specialized centers often involved in clinical research.
authors.affiliation: Biostatistic Department.
authors.forename: A
authors.initials: A
authors.lastname: Dechartres
authors.affiliation: Biostatistic Department; INSERM U717.
authors.forename: S
authors.initials: S
authors.lastname: Chevret
authors.affiliation: Biostatistic Department; INSERM U717.
authors.forename: J
authors.initials: J
authors.lastname: Lambert
authors.affiliation: INSERM CIC 9504, Saint Louis Hospital (Assistance Publique-Hôpitaux de Paris), Paris.
authors.forename: F
authors.initials: F
authors.lastname: Calvo
authors.affiliation: INSERM U717; INSERM CIC 9504, Saint Louis Hospital (Assistance Publique-Hôpitaux de Paris), Paris; Hematology and Oncology Department, Avicenne Hospital (Assistance Publique-Hôpitaux de Paris), Bobigny, France. Electronic address: vincent.levy@avc.aphp.fr.
authors.forename: V
authors.initials: V
authors.lastname: Lévy
mesh_terms: D000293:Adolescent; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000453:epidemiology / Q000628:therapy*; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000453:epidemiology / Q000628:therapy*; D015995:Prevalence; D011446:Prospective Studies