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dc.contributor.authorMiller, Jennifer
dc.contributor.authorMillum, Joseph
dc.identifier.citationMiller , J & Millum , J 2022 , ' Ethical considerations in international clinical trial site selection ' , BMJ Global Health , vol. 7 , no. 4 , e008012 .
dc.identifier.otherPURE: 279193631
dc.identifier.otherPURE UUID: c6ece57a-0190-457d-be45-c744f6008402
dc.identifier.otherJisc: 256592
dc.identifier.otherPubMed: 35387769
dc.identifier.otherpii: bmjgh-2021-008012
dc.identifier.otherScopus: 85128385126
dc.identifier.otherWOS: 000779637500001
dc.description.abstractNew 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.
dc.relation.ispartofBMJ Global Healthen
dc.rightsCopyright © 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:
dc.subjectHealth policies and all other topicsen
dc.subjectPublic Healthen
dc.subjectClinical trialen
dc.subjectVaccines - therapeutic useen
dc.subjectDeveloping Countriesen
dc.subjectHealth policyen
dc.subjectUnited Statesen
dc.subjectRA0421 Public health. Hygiene. Preventive Medicineen
dc.titleEthical considerations in international clinical trial site selectionen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews. Philosophyen
dc.description.statusPeer revieweden

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