Standards of research for clinical trials in low- and middle-income countries

Research supporting the effectiveness and safety of medications for young children in low- and middle-income countries (LMIC) can only be generated if high-quality randomized controlled trials are designed, conducted, and reported appropriately. Clinical research in LMIC is associated with ethical and scientific risks beyond those observed in high-income countries. Scientific challenges of clinical research in LMIC include the need to contain risks of trial bias related to attrition and blinding, definition of the role of data monitoring committees, valid measurement of relevant and standardized outcomes, and inclusion of the appropriate paediatric age sub-groups; ethical challenges particular to clinical research in LMIC include conduct of placebo-controlled clinical trials despite HIC availability of effective comparator interventions, obtaining informed consent despite power inequities, and the obligation to redress health disparities in LMIC. This chapter addresses challenges and proposes ways to navigate these challenges through awareness, regulatory oversight, consultation, and strengthened collaboration with investigators and communities.