title: Healthy volunteers for bioequivalence trials: predictive factors for enrollment failures--a case-control study.
abstract: OBJECTIVE
  To identify social predictors for enrollment failures of healthy volunteers (hv) in bioequivalence trials.
  
  
  METHODS
  Retrospective case-control study. Data was collected from clinical files of hv recruited in 13 bioequivalence trials approved by an independent IRB and local regulatory authority carried out between January and December 2009 at a Pharmacokinetic Unit in Buenos Aires, Argentina. All hv signed the Inform Consent Form. Only subjects who fulfilled all inclusion criteria required by the protocols were studied. Cases (enrollment failures): hv who fulfilled the protocols eligibility criteria but were not enrolled in the trials by their own decision.
  
  
  METHODS
  hv who fulfilled all the protocols eligibility criteria and were enrolled. Cases and controls were matched by demographic/ physical data and compared in relation to database contact, unemployment, alcoholic/ drug family environment, history of alcohol/ drug abuse, and other social variables. Chi2-test and t-test were used to compare data; variables presenting statistical difference were included in a logistic regression model.
  
  
  RESULTS
  A sample of 375 hv. was analyzed. cases: 81/375(21.60%). Controls: 294/375 (78.40%). Cases did not differ from controls in relation to nationality, educational level, length of study and history of alcohol abuse. Statistical differences between cases and controls were found in non-database contact, unemployment, alcoholic environment, drug abuse environment and personal history of drug abuse. In a multivariate analysis only unemployment, (OR: 4.20, p < 0.001), non-database contact, (OR: 2.35, p = 0.004) and alcoholic environment, (OR: 1.94, p = 0.045) remained as predictive factors.
  
  
  CONCLUSIONS
  In bioequivalence trials, an unemployment condition, and an alcoholic family environment were identified as negative predictors for effective enrollment in new healthy volunteers.
authors.affiliation: F.P.Clinical Pharma, Buenos Aires, Argentina. gyerino@fpclinicalpharma.com.ar
authors.forename: G A
authors.initials: GA
authors.lastname: Yerino
authors.forename: E K
authors.initials: EK
authors.lastname: Halabe
authors.forename: E C
authors.initials: EC
authors.lastname: Feleder
mesh_terms: D000328:Adult; D000437:Alcoholism / Q000453:epidemiology; D016022:Case-Control Studies; D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D018579:Patient Selection; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D035842:Research Subjects / Q000600:supply & distribution*; D012189:Retrospective Studies; D013810:Therapeutic Equivalency; D014478:Unemployment / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D004364:Pharmaceutical Preparations