title: Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review.
abstract: BACKGROUND
  Clinical trials are necessary to improve the health care of children, but only one-quarter are conducted in the low- to middle-income countries (LMICs) in which 98% of the global burden of disease resides.
  
  
  OBJECTIVE
  To describe stakeholder beliefs and experiences of conducting trials in children in LMICs.
  
  
  METHODS
  Electronic databases were searched to August 2014.
  
  
  METHODS
  Qualitative studies of stakeholder perspectives on conducting clinical trials among children in LMICs.
  
  
  METHODS
  Findingswere analyzed by using thematic synthesis.
  
  
  RESULTS
  Thirty-nine studies involving 3110 participants (children [n = 290], parents or caregivers [n = 1609], community representatives [n = 621], clinical or research team members [n = 376], regulators [n = 18], or sponsors [n = 15]) across 22 countries were included. Five themes were identified: centrality of community engagement (mobilizing community, representatives' pivotal role, managing expectations, and retaining involvement); cognizance of vulnerability and poverty (therapeutic opportunity and medical mistrust); contending with power differentials (exploitation, stigmatization, and disempowerment); translating research to local context (cultural beliefs, impoverishment constraints, and ethical pluralism); and advocating fair distribution of benefits (health care, sponsor obligation, and collateral community benefits).
  
  
  CONCLUSIONS
  Studies not published in English were excluded.
  
  
  CONCLUSIONS
  Conducting trials in children in LMICs is complex due to social disadvantage, economic scarcity, idiosyncratic cultural beliefs, and historical disempowerment, all of which contribute to inequity, mistrust, and fears of exploitation. Effective community engagement in recruiting, building research capacities, and designing trials that are pragmatic, ethical, and relevant to the health care needs of children in LMICs may help to improve the equity and health outcomes of this vulnerable population.
authors.affiliation: Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia; Discipline of Paediatrics and Child Health, and The Pharmacy Department, The Children's Hospital at Westmead, Sydney, Australia pathma.joseph@health.nsw.gov.au.
authors.forename: Pathma D
authors.initials: PD
authors.lastname: Joseph
authors.affiliation: Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia; Discipline of Paediatrics and Child Health, and.
authors.forename: Patrina H Y
authors.initials: PH
authors.lastname: Caldwell
authors.affiliation: Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia; Sydney School of Public Health, The University of Sydney, Sydney, Australia; and.
authors.forename: Allison
authors.initials: A
authors.lastname: Tong
authors.affiliation: Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia; Sydney School of Public Health, The University of Sydney, Sydney, Australia; and.
authors.forename: Camilla S
authors.initials: CS
authors.lastname: Hanson
authors.affiliation: Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia; Sydney School of Public Health, The University of Sydney, Sydney, Australia; and.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Craig
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics*; D003469:Culture; D003906:Developing Countries; D006801:Humans; D010372:Pediatrics; D011203:Poverty; D035842:Research Subjects; D035502:Trust; D035862:Vulnerable Populations