title: Rates of inclusion of teenagers and young adults in England into National Cancer Research Network clinical trials: report from the National Cancer Research Institute (NCRI) Teenage and Young Adult Clinical Studies Development Group.
abstract: Poor inclusion rates into clinical trials for teenagers and young adults (TYA; aged 13-24 years) have been assumed but not systematically investigated in England. We analysed accrual rates (AR) from 1 April 2005 up to 31 March 2007 to National Cancer Research Network (NCRN) Phase III trials for the commonest tumour types occurring in TYA and children: leukaemia, lymphoma, brain and central nervous system, bone sarcomas and male germ cell tumours. AR for 2005-2007 were 43.2% for patients aged 10-14 years, 25.2% for patients aged 15-19 years, and 13.1% for patients aged 20-24 years in the tumour types analysed. Compared with accrual from 1 April 2005 to 31 March 2006, AR between 1 April 2006 and 31 March 2007 increased for those aged 10-14 and 15-19 years, but fell for those aged 20-24 years. AR varied considerably among cancer types. Despite four trials being available, patients over 16 years with central nervous system tumours were not recruited. Rates of participation in clinical trials in England from 2005 to 2007 were much lower for TYA older than 15 years compared with children and younger teenagers. The variations in open trials, trial age eligibility criteria and extent of trial activation in treatment centres in part explain this observation. Other possible influences, such as difficulties associated with the consent of TYA require further evaluation. Closer dialogue between those involved in planning and running trials for children and for adults is necessary to improve trial availability and recruitment. Further research is required to identify trends in trial availability and accrual for those tumours constituting the remaining 26% of TYA cancers.
authors.affiliation: 1Department of Oncology, University College London Hospitals NHS trust, London NW1 2PG, UK.
authors.forename: L
authors.initials: L
authors.lastname: Fern
authors.forename: S
authors.initials: S
authors.lastname: Davies
authors.forename: T
authors.initials: T
authors.lastname: Eden
authors.forename: R
authors.initials: R
authors.lastname: Feltbower
authors.forename: R
authors.initials: R
authors.lastname: Grant
authors.forename: M
authors.initials: M
authors.lastname: Hawkins
authors.forename: I
authors.initials: I
authors.lastname: Lewis
authors.forename: E
authors.initials: E
authors.lastname: Loucaides
authors.forename: C
authors.initials: C
authors.lastname: Rowntree
authors.forename: S
authors.initials: S
authors.lastname: Stenning
authors.forename: J
authors.initials: J
authors.lastname: Whelan
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D002648:Child; D002675:Child, Preschool; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D004739:England / Q000453:epidemiology; D035082:Federal Government; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology*; D013997:Time Factors; D055815:Young Adult