title: Barriers to study enrollment in patients with advanced cancer referred to a phase I clinical trials unit.
abstract: We conducted this retrospective study to identify reasons that patients referred to a phase I clinical trial failed to enroll or delayed enrollment onto the trial.
  
  
  METHODS
  Outcome analyses were conducted independently on data collected from electronic medical records of two sets of consecutive patients referred to a phase I clinical trial facility at MD Anderson Cancer Center. Data from the first set of 300 patients were used to determine relevant variables affecting enrollment; data from the second set of 957 patients were then analyzed for these variables.
  
  
  RESULTS
  Results from the two sets of patients were similar. Approximately 55% of patients were enrolled in a phase I trial. Patients referred from within MD Anderson were more likely to be enrolled than patients seen originally outside the institution (p = .006); black patients were more likely than white patients to enroll (69% vs. 43%; p = .04). The median interval from the initial visit to initiation of treatments was 19 days. Major reasons for failure to enroll included failure to return to the clinic (36%), opting for treatment in another clinic (17%), hospice referral (11%), early death (10%), and lack of financial clearance (5%). Treatment was delayed for three weeks or more in 250 patients; in 85 patients (34%), the delay was caused by financial and insurance issues.
  
  
  CONCLUSIONS
  Failure to return to the clinic, pursuit of other therapy, and rapid deterioration were the major reasons for failure to enroll; lengthy financial clearance was the most common reason for delayed enrollment onto a phase I trial.
authors.affiliation: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, Texas, USA;
authors.forename: Siqing
authors.initials: S
authors.lastname: Fu
authors.forename: Lacey
authors.initials: L
authors.lastname: McQuinn
authors.forename: Aung
authors.initials: A
authors.lastname: Naing
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Wheler
authors.forename: Filip
authors.initials: F
authors.lastname: Janku
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Falchook
authors.forename: Sarina A
authors.initials: SA
authors.lastname: Piha-Paul
authors.forename: Dennis
authors.initials: D
authors.lastname: Tu
authors.forename: Adrienne
authors.initials: A
authors.lastname: Howard
authors.forename: Apostolia
authors.initials: A
authors.lastname: Tsimberidou
authors.forename: Ralph
authors.initials: R
authors.lastname: Zinner
authors.forename: David S
authors.initials: DS
authors.lastname: Hong
authors.forename: Razelle
authors.initials: R
authors.lastname: Kurzrock
mesh_terms: D000293:Adolescent; D000368:Aged; D017321:Clinical Trials, Phase I as Topic; D005260:Female; D006738:Hospices; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms; D010358:Patient Participation / Q000523:psychology / Q000706:statistics & numerical data; D012017:Referral and Consultation; D012189:Retrospective Studies
keywords: Barrier; Consults; Enrollment; New patients; Patient referral; Phase I trial