Abstract
BackgroundIt is essential that clinical trial participants are representative of the population under investigation. Using HIV-associated cryptococcal meningitis (CM) as a case study, we conducted a systematic review of clinical trials to determine how inclusive and representative they were both in terms of the affected population and the involvement of local investigators.MethodsWe searched Medline, EMBASE, Cochrane, Africa-Wide, CINAHL Plus, and Web of Science. Data were extracted for 5 domains: study location and design, screening, participants, researchers, and funders. Data were summarised and compared over 3 time periods: pre-antiretroviral therapy (ART) (pre-2000), early ART (2000 to 2009), and established ART (post-2010) using chi-squared and chi-squared for trend. Comparisons were made with global disease burden estimates and a composite reference derived from observational studies.ResultsThirty-nine trials published between 1990 and 2019 were included. Earlier studies were predominantly conducted in high-income countries (HICs) and recent studies in low- and middle-income countries (LMICs). Most recent studies occurred in high CM incidence countries, but some highly affected countries have not hosted trials. The sex and ART status of participants matched those of the general CM population. Patients with reduced consciousness and those suffering a CM relapse were underrepresented. Authorship had poor representation of women (29% of all authors), particularly as first and final authors. Compared to trials conducted in HICs, trials conducted in LMICs were more likely to include female authors (32% versus 20% p = 0.014) but less likely to have authors resident in (75% versus 100%, p < 0.001) or nationals (61% versus 93%, p < 0.001) of the trial location.ConclusionsThere has been a marked shift in CM trials over the course of the HIV epidemic. Trials are primarily performed in locations and populations that reflect the burden of disease, but severe and relapse cases are underrepresented. Most CM trials now take place in LMICs, but the research is primarily funded and led by individuals and institutions from HICs.
Highlights
Global health research is a rapidly expanding and evolving field, and global health practitioners are increasingly reflecting on the ethos and equity of research [1,2,3]
Earlier studies were predominantly conducted in high-income countries (HICs) and recent studies in low- and middle-income countries (LMICs)
The sex and antiretroviral therapy (ART) status of participants matched those of the general cryptococcal meningitis (CM) population
Summary
Global health research is a rapidly expanding and evolving field, and global health practitioners are increasingly reflecting on the ethos and equity of research [1,2,3]. Concerns have been raised that clinical trials are disproportionately conducted in a limited number of countries [4,5,6,7] and that individual researchers and institutions from high-income countries (HICs) disproportionately benefit from global health research [8], leading to calls to examine and potentially reform how global health research is conceptualised and conducted. The emergence of the HIV epidemic was a catalyst for huge investment in global health, both in terms of research and service provision [9]. This expansion in investment led to the creation of a large number of transnational research partnerships (TRPs), whereby institutions in HICs partnered with those in low- and middle-income countries (LMICs) to collaborate on research studies [10]. Using HIV-associated cryptococcal meningitis (CM) as a case study, we conducted a systematic review of clinical trials to determine how inclusive and representative they were both in terms of the affected population and the involvement of local investigators
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