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Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials?

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Footnotes

  • Competing interests: CM is actively engaged in recruiting patients to clinical trials conducted by the Children’s Cancer and Leukaemia Group and sponsored by the University of Sheffield and University of Leicester.

  • Abbreviations:
    ALL
    acute lymphoblastic leukaemia
    BFM group
    Berlin-Frankfurt-Munster group
    CCG
    Children’s Cancer Group
    EFS
    event-free survival
    ENSG
    European Neuroblastoma Study Group
    EORTC
    European Organisation for Research and Treatment of Cancer
    EUCTD
    EU Clinical Trials Directive
    HDM
    high-dose melphalan
    MHRA
    Medicines and Healthcare products Regulatory Agency
    MRD
    minimal residual disease
    NCRI
    National Cancer Research Institute
    NWTS
    National Wilms’ Tumor Study
    OS
    overall survival
    RT-PCR
    real-time quantitative polymerase chain reaction
    SIOP
    International Society of Paediatric Oncology
    UKCCSG
    UK Children’s Cancer Study Group