Equity in clinical trials for HIV-associated cryptococcal meningitis: A systematic review of global representation and inclusion of patients and researchers

David S Lawrence, Tshepo Leeme, Mosepele Mosepele, Thomas S Harrison, Janet Seeley and Joseph N Jarvis

PLOS Neglected Tropical Diseases, 2021, vol. 15, issue 5, 1-19

Abstract: Background: It 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. Methods: We 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. Results: Thirty-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

Date: 2021
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0009376 (text/html)
https://journals.plos.org/plosntds/article?id=10.1 ... 09376&type=printable (application/pdf)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:plo:pntd00:0009376

DOI: 10.1371/journal.pntd.0009376

Access Statistics for this article

More articles in PLOS Neglected Tropical Diseases from Public Library of Science
Bibliographic data for series maintained by plosntds ().