Joseph Pathma D, Caldwell Patrina H Y, Tong Allison, Hanson Camilla S, Craig Jonathan C
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
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia; Discipline of Paediatrics and Child Health, and.
Pediatrics. 2016 Feb;137(2):e20152800. doi: 10.1542/peds.2015-2800. Epub 2016 Jan 26.
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.
To describe stakeholder beliefs and experiences of conducting trials in children in LMICs.
Electronic databases were searched to August 2014.
Qualitative studies of stakeholder perspectives on conducting clinical trials among children in LMICs.
Findingswere analyzed by using thematic synthesis.
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).
Studies not published in English were excluded.
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.
临床试验对于改善儿童医疗保健状况很有必要，但仅有四分之一的试验在低收入和中等收入国家（LMICs）开展，而全球98%的疾病负担都集中在这些国家。
描述利益相关者对在低收入和中等收入国家开展儿童试验的看法和经历。
检索电子数据库至2014年8月。
关于利益相关者对在低收入和中等收入国家儿童中开展临床试验的观点的定性研究。
采用主题综合法分析研究结果。
纳入了来自22个国家的39项研究，涉及3110名参与者（儿童[n = 290]、父母或照料者[n = 1609]、社区代表[n = 621]、临床或研究团队成员[n = 376]、监管者[n = 18]或赞助商[n = 15]）。确定了五个主题：社区参与的核心地位（动员社区、代表的关键作用、管理期望以及保持参与）；认识到脆弱性和贫困（治疗机会和医疗不信任）；应对权力差异（剥削、污名化和丧失权力）；将研究转化为当地情况（文化信仰、贫困限制和伦理多元主义）；倡导公平分配利益（医疗保健、赞助商义务和附带的社区利益）。
未发表英文版本的研究被排除。
由于社会劣势、经济匮乏、独特的文化信仰以及历史上的无权状况，在低收入和中等收入国家开展儿童试验很复杂，所有这些因素都导致了不公平、不信任以及对剥削的恐惧。有效的社区参与招募、建设研究能力以及设计切实可行、符合伦理且与低收入和中等收入国家儿童医疗保健需求相关的试验，可能有助于改善这一弱势群体的公平性和健康结果。
