title: Evaluation of patient enrollment in oncology phase I clinical trials.
abstract: BACKGROUND
  For anticancer drug development, it is crucial that patients participate in early-phase clinical trials. The main aim of this study was to gain insight into the motivations and other variables influencing patients in their decision to participate in phase I oncology trials.
  
  
  METHODS
  Over a period of 25 months, all patients who were informed about (specific) phase I trials in our cancer center were retrospectively included in this study. Data on providing informed consent and final phase I enrollment were collected.
  
  
  RESULTS
  In total, 365 patients, with a median age of 59 years and a median World Health Organization performance status score of 1, were evaluated. The majority of patients (71%) were pretreated with systemic therapy, with a median of two lines. After specific study information had been given, 145 patients (40%) declined informed consent, 54% of them mainly because of low expectations regarding treatment benefits and concerns about potential side effects. Patients who had received previous systemic therapy consented more frequently than others. After initial consent, 61 patients (17%) still did not receive study treatment, mostly because of secondary withdrawal of consent or rapid clinical deterioration prior to first dosing.
  
  
  CONCLUSIONS
  After specific referral to our hospital for participation in early clinical trials, only 44% of all patients who were informed about a specific phase I trial eventually participated. Reasons for both participation and nonparticipation were diverse. Patient participation rates could be improved by forming an experienced and dedicated study team.
authors: Department of Medical Oncology, Erasmus University Medical Center – Daniel den Hoed Cancer Center, Rotterdam, The Netherlands.
authors: Diane A J
authors: DA
authors: van der Biessen
authors: Merlijn A
authors: MA
authors: Cranendonk
authors: Gaia
authors: G
authors: Schiavon
authors: Bronno
authors: B
authors: van der Holt
authors: Erik A C
authors: EA
authors: Wiemer
authors: Ferry A L M
authors: FA
authors: Eskens
authors: Jaap
authors: J
authors: Verweij
authors: Maja J A
authors: MJ
authors: de Jonge
authors: Ron H J
authors: RH
authors: Mathijssen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001530:Belgium / Q000453:epidemiology; D002986:Clinical Trials as Topic / Q000379:methods / Q000523:psychology* / Q000706:statistics & numerical data*; D006801:Humans; D008495:Medical Oncology / Q000379:methods* / Q000706:statistics & numerical data*; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology / Q000523:psychology / Q000628:therapy; D009426:Netherlands / Q000453:epidemiology; D010358:Patient Participation / Q000523:psychology* / Q000706:statistics & numerical data*; D055815:Young Adult