title: Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials.
abstract: OBJECTIVE
  Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness.
  
  
  METHODS
  Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost.
  
  
  RESULTS
  In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies.
  
  
  CONCLUSIONS
  We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data management.
authors.affiliation: Vacceleron, Leiden Department of Anaesthesiology, Leiden University Medical Centre, Leiden Centre for Human Drug Research, Leiden Profess Medical Consultancy BV, Heerhugowaard, The Netherlands. e.s.pronker@gmail.com
authors.forename: Esther
authors.initials: E
authors.lastname: Pronker
authors.forename: Bart F
authors.initials: BF
authors.lastname: Geerts
authors.forename: Adam
authors.initials: A
authors.lastname: Cohen
authors.forename: Herman
authors.initials: H
authors.lastname: Pieterse
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000191:economics*; D003362:Cost-Benefit Analysis / Q000191:economics* / Q000592:standards; D003365:Costs and Cost Analysis / Q000191:economics; D004341:Drug Evaluation / Q000191:economics* / Q000592:standards; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards; D012107:Research Design