title: Do disparities between populations in randomized controlled trials and the real world lead to differences in outcomes?
abstract: OBJECTIVE
  To conduct a systematic review investigating reasons for the disparity between the efficacy and effectiveness rates reported in randomized controlled trials (RCTs) and observational studies of direct-acting antiviral treatment regimens licensed for use in genotype1 hepatitis C virus-infected individuals.
  
  
  METHODS
  This systematic review was conducted in accordance with the criteria of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses group.
  
  
  RESULTS
  Statistically significant (p < 0.05) differences in the baseline demographics and sustained virological response rates were observed between RCT and observational studies.
  
  
  CONCLUSIONS
  In order for outcomes from RCTs to be generalizable to the real world, greater consideration needs to be taken to include patient populations that are more representative of those awaiting treatment in the clinical setting.
authors.affiliation: School of Medicine, Trinity College Dublin, Dublin, Ireland.
authors.forename: Emma
authors.initials: E
authors.lastname: Gray
authors.affiliation: School of Medicine, Trinity College Dublin, Dublin, Ireland.|Departmentof Hepatology, St James' Hospital, Dublin, Ireland.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Norris
authors.affiliation: HealthEconomics & Evidence Synthesis Research Unit, Department of PopulationHealth, Luxembourg Health Institute, Luxembourg.
authors.forename: Susanne
authors.initials: S
authors.lastname: Schmitz
authors.affiliation: Schoolof Pharmacy, Royal College of Surgeons of Ireland, Dublin, Ireland.|NationalCentre for Pharmacoeconomics, St James' Hospital, Dublin, Ireland.
authors.forename: Aisling
authors.initials: A
authors.lastname: O'Leary
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D054624:Health Status Disparities; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D064887:Observational Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents
keywords: direct-acting antiviral agents; effectiveness; efficacy; hepatitis C; observational studies; randomized controlled trials; systematic review