title: Determinants of patient screen failures in Phase 1 clinical trials.
abstract: OBJECTIVE
  Certain eligibility criteria for Phase 1 cancer clinical trials may impede successful patient enrollment onto a study. We evaluated patient-specific or study-specific reasons for screen failures on Phase 1 oncology clinical trials and discuss factors which may inhibit subject enrollment.
  
  
  METHODS
  Thirty-eight Phase 1 clinical trials for solid tumors meeting eligibility criteria and opened for enrollment between February 2006 and February 2011 at one oncology Phase 1 program were examined. Categorical reasons for screen failures and patients' demographics were examined and compared to characteristics of patients that successfully enrolled on a Phase 1 trial.
  
  
  RESULTS
  There were a total of 583 successful Phase 1 enrollment and dose administration events out of 773 Phase 1 consent events (75.4 % dose success rate). The three most common reasons for screen failure were: out of protocol-specified range for chemistry, development of an interval medical issue that precluded proceeding with study participation, and subject declining participation after signing consent. Living further away from the Phase 1 program and receipt of fewer prior lines of systemic chemotherapy were significantly associated with increased screen failures.
  
  
  CONCLUSIONS
  Screen failures for Phase 1 studies are not uncommon (24.6 %). When a protocol required tumor or host analyte is not required, most screen failures are due to out of protocol-specified range for chemistry or the development of an interval medical issue. Screen failure rates were increased when patients had longer travel distances and fewer prior lines of systemic chemotherapy.
authors.affiliation: Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, 10510 N 92nd St. Ste 200, Scottsdale, AZ, 85258, USA.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Mckane
authors.forename: Chao
authors.initials: C
authors.lastname: Sima
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Ramanathan
authors.forename: Gayle
authors.initials: G
authors.lastname: Jameson
authors.forename: Cathy
authors.initials: C
authors.lastname: Mast
authors.forename: Erica
authors.initials: E
authors.lastname: White
authors.forename: Sharon
authors.initials: S
authors.lastname: Fleck
authors.forename: Molly
authors.initials: M
authors.lastname: Downhour
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Von Hoff
authors.forename: Glen J
authors.initials: GJ
authors.lastname: Weiss
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic; D015507:Drugs, Investigational / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000188:drug therapy; D018579:Patient Selection
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational