Ethical considerations in international clinical trial site selection
Abstract
New medicines and vaccines are predominantly tested in high-income countries. However, as the COVID-19 pandemic highlighted, the populations who can benefit from these interventions are not limited to these wealthier regions. One-third of novel Food and Drug Administration approved drugs, sponsored by large companies, treat infectious diseases like tuberculosis and HIV, which disproportionately affect low-income and middle-income countries (LMICs). The medicines for non-communicable diseases (NCDs) are also relevant to LMIC health needs, as over three-quarters of deaths from NCDs occur in LMICs. There are concerns clinical trial data may not extrapolate across geographical regions, as product effectiveness can vary substantially by region. The pentavalent rotavirus vaccine, for example, had markedly lower efficacy in LMICs. Efficacy variations have also been found for other vaccines and drugs. We argue there are strong ethical arguments for remedying some of this uneven distribution of clinical trial sites by geography and income. Chief among them, is that these disparities can impede equitable access to the benefits of clinical research, such as representation in the evidence base generated to guide prescribing and use of medicines and vaccines. We suggest trial site locations should be made more transparent and for later stage trials their selection should be informed by the global distribution of disease burden targeted by an experimental product. Countries with high prevalence, incidence, severity or infection transmission rates for targeted diseases should have real opportunities to engage in and enrol their populations in trials for novel medicines and vaccines.
Citation
Miller , J & Millum , J 2022 , ' Ethical considerations in international clinical trial site selection ' , BMJ Global Health , vol. 7 , no. 4 , e008012 . https://doi.org/10.1136/bmjgh-2021-008012
Publication
BMJ Global Health
Status
Peer reviewed
ISSN
2059-7908Type
Journal article
Rights
Copyright © Author(s) (or their employer(s)) 2022. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Collections
Items in the St Andrews Research Repository are protected by copyright, with all rights reserved, unless otherwise indicated.
Related items
Showing items related by title, author, creator and subject.
-
Effect of free medicine distribution on health care costs in Canada over 3 years : a secondary analysis of the CLEAN meds randomized clinical trial
Persaud, Nav; Bedard, Michael; Boozary, Andrew; Glazier, Richard H; Gomes, Tara; Hwang, Stephen W; Jüni, Peter; Law, Michael R; Mamdani, Muhammad; Manns, Braden; Martin, Danielle; Morgan, Steven G; Oh, Paul; Pinto, Andrew D; Shah, Baiju R; Sullivan, Frank; Umali, Norman; Thorpe, Kevin E; Tu, Karen; Wu, Fangyun; Laupacis, Andreas; CLEAN Meds study team (2023-05-26) - Journal articleIMPORTANCE : Few interventions are proven to reduce total health care costs, and addressing cost-related nonadherence has the potential to do so. OBJECTIVE : To determine the effect of eliminating out-of-pocket medication ... -
Pädiatrische versorgungskonzepte in Europa
Weber, Martin W; Backhaus, Sophia; Chukwujama, Obiora; Fenski, Friederike; Henking, Christoph; Schatte, Laura; Aleman-Diaz, Aixa Y (2018-01-19) - Journal articleTo promote children’s health in Europe, the World Health Organization (WHO) developed the European child and adolescent health strategy 2015–2020, which is supported and will be implemented by all Member States (MS). In ... -
Arts-based approaches to promoting health in sub-Saharan Africa : a scoping review
Bunn, Christopher; Kalinga, Chisomo; Mtema, Otiyela; Abdulla, Sharifa; DIllip, Angel; Lwanda, John; Mtenga, Sally M.; Sharp, Jo; Strachan, Zoë; Gray, Cindy M. (2020-05-21) - Journal itemIntroduction Arts-based approaches to health promotion have been used widely across sub-Saharan Africa (SSA), particularly in public health responses to HIV/AIDS. Such approaches draw on deep-rooted historical traditions ...