title: Recruitment of childhood leukaemia patients to clinical trials in Great Britain during 1980-2007: variation by birth weight, congenital malformation, socioeconomic status and ethnicity.
abstract: OBJECTIVE
  To assess recruitment of children to national clinical trials for acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML) in Great Britain during 1980-2007 and describe variation by some factors that might influence trial entry.
  
  
  METHODS
  Records of leukaemia patients aged 0-14 years at diagnosis were identified in the National Registry of Childhood Tumours and linked to birth registrations, Children's Cancer and Leukaemia Group records, Hospital Episode Statistics and Medical Research Council clinical trial registers. Trial entry rates were compared between categories of birth weight, congenital malformation, socioeconomic status and ethnicity.
  
  
  RESULTS
  9147 ALL and 1466 AML patients were eligible for national clinical trials during 1980-2007. Overall recruitment rates were 81% and 60% respectively. For ALL, rates varied significantly with congenital malformation (Down syndrome 61%, other malformations 80%, none 82%; p<0.001) and ethnicity (South Asian 78%, other minority groups 80%, white 85%; p<0.001). For AML, rates varied with birth weight (< 2500 g 48%, 2500-4000 g 69%, >4000 g 67%; p=0.001) and congenital malformation (Down syndrome 28%, other malformations 56%, none 63%; p<0.001).
  
  
  CONCLUSIONS
  Although recruitment rates to clinical trials for childhood leukaemia are high, future trials should monitor possible variation by birth weight, ethnicity and presence of congenital malformations.
authors.affiliation: Childhood Cancer Research Group, University of Oxford, , Oxford, UK.
authors.forename: Anjali
authors.initials: A
authors.lastname: Shah
authors.forename: Nicole
authors.initials: N
authors.lastname: Diggens
authors.forename: Charles
authors.initials: C
authors.lastname: Stiller
authors.forename: Sue
authors.initials: S
authors.lastname: Richards
authors.forename: Michael C G
authors.initials: MC
authors.lastname: Stevens
authors.forename: Michael F G
authors.initials: MF
authors.lastname: Murphy
mesh_terms: D000293:Adolescent; D001724:Birth Weight; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D000013:Congenital Abnormalities / Q000208:ethnology*; D005006:Ethnicity; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015470:Leukemia, Myeloid, Acute / Q000208:ethnology*; D018579:Patient Selection; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000208:ethnology*; D012042:Registries; D012923:Social Class; D006113:United Kingdom
keywords: Congenital Abnorm; Epidemiology; Haematology; Paediatric