Identification of factors limiting patient recruitment into phase I trials: a study from the Royal Marsden Hospital

Eur J Cancer. 2008 May;44(7):978-82. doi: 10.1016/j.ejca.2008.02.040. Epub 2008 Mar 24.


Aim: 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.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / therapeutic use*
  • Clinical Trials, Phase I as Topic / methods*
  • Female
  • Hospitalization
  • Humans
  • London
  • Male
  • Medical Audit
  • Middle Aged
  • Neoplasms / drug therapy*
  • Patient Selection*
  • Referral and Consultation / organization & administration*
  • Referral and Consultation / standards
  • Retrospective Studies
  • Time Factors
  • Waiting Lists


  • Antineoplastic Agents