title: Identification of factors limiting patient recruitment into phase I trials: a study from the Royal Marsden Hospital.
abstract: OBJECTIVE
  To identify factors that may prevent or delay patients referred for consideration of phase I studies from commencing such a study.
  
  
  METHODS
  A retrospective audit of phase I study referrals for the period 1st March to 31st August 2005 to the Drug Development Unit was performed. All reasons that led to either delay or recruitment failure were documented and analysed.
  
  
  RESULTS
  Data from 176 patients (105M/71F) were analysed. Median age at referral was 59 years and median performance status (PS) was 1. Of these, 56 (32%) were successfully recruited in a phase I trial. The median time from trial allocation to commencement of treatment was 4.8 weeks. Poor or deteriorating PS was the reason for delay or recruitment failure in 43 (35%) of non-recruited patients.
  
  
  CONCLUSIONS
  Poor or deteriorating PS was the most common factor limiting accrual to phase I trials. Better patients' selection on this basis might improve recruitment rates.
authors: Drug Development Unit, Sycamore House, Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT, UK.
authors: Vasilios
authors: V
authors: Karavasilis
authors: Laurence
authors: L
authors: Digue
authors: Tobias
authors: T
authors: Arkenau
authors: David
authors: D
authors: Eaton
authors: Sarah
authors: S
authors: Stapleton
authors: Johann
authors: J
authors: de Bono
authors: Ian
authors: I
authors: Judson
authors: Stan
authors: S
authors: Kaye
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D005260:Female; D006760:Hospitalization; D006801:Humans; D008131:London; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D012017:Referral and Consultation / Q000458:organization & administration* / Q000592:standards; D012189:Retrospective Studies; D013997:Time Factors; D014850:Waiting Lists
chemical_list: D000970:Antineoplastic Agents