title: [Public clinical trials: which kind of monitoring should be used?].
abstract: OBJECTIVE
  Sponsors must take responsibility for the quality of trials at the best possible cost. Our objective was to describe the most frequent quality failures, how they impact trial results, and identify the most efficient monitoring strategies using published articles and reports.
  
  
  RESULTS
  Errors affecting clinical trials include conception, procedures, data management, and data analysis. The consequences are usually an overestimation of the treatment effect. No study shows that monitoring reduces the risk of errors, and there is no comparison of monitoring methods. Many research organisations advocate for monitoring based on risk analysis and recommend an extensive use of centralised monitoring.
  
  
  CONCLUSIONS
  Trial quality depends on trial conception and design. Study conduct should guarantee a maximum level of quality level. This should be done using risk management and extensive centralised monitoring.
authors.affiliation: Service de Pharmacologie Clinique, Lyon, France. catherine.cornu@chu-lyon.fr
authors.forename: Catherine
authors.initials: C
authors.lastname: Cornu
authors.forename: Christine
authors.initials: C
authors.lastname: Binquet
authors.forename: Claire
authors.initials: C
authors.lastname: Thalamas
authors.forename: Céline
authors.initials: C
authors.lastname: Vigouroux
authors.forename: Ségolène
authors.initials: S
authors.lastname: Gaillard
authors.forename: Tiphanie
authors.initials: T
authors.lastname: Ginhoux
authors.forename: Bernadette
authors.initials: B
authors.lastname: Vaz
authors.forename: Claire
authors.initials: C
authors.lastname: Jossan
authors.forename: Alexandra
authors.initials: A
authors.lastname: Félin
authors.forename: Annabelle
authors.initials: A
authors.lastname: Sailly
authors.forename: François
authors.initials: F
authors.lastname: Gueyffier
authors.forename: Valérie
authors.initials: V
authors.lastname: Journot
authors.forename: Behrouz
authors.initials: B
authors.lastname: Kassaï
mesh_terms: D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D006801:Humans; D011786:Quality Control; D019984:Quality Indicators, Health Care; D012107:Research Design; D012308:Risk Management