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Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review
Pathma D Joseph1, Patrina H Y Caldwell2, Allison Tong3
1Centre 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.
Insights
Conducting clinical trials in low- and middle-income countries (LMICs) for children is complex. Effective community engagement and culturally relevant trial design are crucial for improving equity and health outcomes for this vulnerable population.
Area of Science:
- Global Health
- Pediatric Clinical Trials
- Research Ethics
Background:
- Clinical trials are vital for advancing pediatric healthcare.
- Low- and middle-income countries (LMICs) bear 98% of the global disease burden but conduct only 25% of child health trials.
- Limited research exists on conducting trials in children within LMICs.
Purpose of the Study:
- To explore stakeholder perspectives on conducting clinical trials in children within LMICs.
- To identify challenges and facilitators for pediatric clinical trial implementation in resource-limited settings.
Main Methods:
- A systematic review of qualitative studies was conducted.
- Electronic databases were searched up to August 2014.
- Thematic synthesis was used to analyze findings from 39 studies across 22 countries.
Main Results:
- Five key themes emerged: community engagement, awareness of vulnerability and poverty, power differentials, adapting research to local contexts, and fair benefit distribution.
- Stakeholders highlighted the importance of community involvement, addressing mistrust, and mitigating exploitation fears.
- Cultural beliefs, poverty, and ethical pluralism significantly influence trial conduct and outcomes.
Conclusions:
- Conducting pediatric trials in LMICs is challenging due to socioeconomic, cultural, and historical factors contributing to inequity and mistrust.
- Enhanced community engagement, capacity building, and pragmatic, ethical trial design are essential.
- Improving trial equity and health outcomes for children in LMICs requires addressing these complex issues.
Context:
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.
Data Sources:
Electronic databases were searched to August 2014.
Study Selection:
Qualitative studies of stakeholder perspectives on conducting clinical trials among children in LMICs.
Data Extraction:
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).
Limitations:
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.
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