title: Barriers in phase I cancer clinical trials referrals and enrollment: five-year experience at the Princess Margaret Hospital.
abstract: BACKGROUND
  There is a paucity of literature on the referral outcome of patients seen in phase I trial clinics in academic oncology centres. This study aims to provide information on the accrual rate and to identify obstacles in the recruitment process.
  
  
  METHODS
  A retrospective chart review was performed for all new patients referred and seen in the phase I clinic at the Princess Margaret Hospital between January 2000 and June 2005. Data on their demographics, medical history, and details of trial participation or non-entry were recorded.
  
  
  RESULTS
  A total of 667 new phase I referrals were seen during the stated period. Of these patients, 197 (29.5%) patients were enrolled into a phase I trial, and 64.5% of them started trial within 1 month of the initial visit. About a quarter (165 of 667) of the patients referred were deemed ineligible at their first visit, with the most frequent reasons for ineligibility being poor performance status, unacceptable bloodwork, too many prior treatments and rapid disease progression. The remaining 305 patients (45.7%) were potentially eligible at their initial visit, but never entered a phase I trial. The main reasons for their non-entry were patient refusal, other treatment recommended first, and lack of available trials or trial spots.
  
  
  CONCLUSIONS
  This study provides information on the clinical realities underlying a referral to a phase I clinic and eventual trial enrollment. Better selection of patients, appropriate education of referring physicians, and opening phase I trials with fewer restrictions on some criteria such as prior therapy may enhance their recruitment rates.
authors.affiliation: Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada. jjh_mythos@hotmail.com <jjh_mythos@hotmail.com>
authors.forename: Jeremy
authors.initials: J
authors.lastname: Ho
authors.forename: Gregory R
authors.initials: GR
authors.lastname: Pond
authors.forename: Colin
authors.initials: C
authors.lastname: Newman
authors.forename: Martha
authors.initials: M
authors.lastname: Maclean
authors.forename: Eric X
authors.initials: EX
authors.lastname: Chen
authors.forename: Amit M
authors.initials: AM
authors.lastname: Oza
authors.forename: Lillian L
authors.initials: LL
authors.lastname: Siu
mesh_terms: D000046:Academic Medical Centers; D000368:Aged; D017321:Clinical Trials, Phase I as Topic; D004608:Eligibility Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D018579:Patient Selection; D012017:Referral and Consultation; D012189:Retrospective Studies