Clinical Trials and Scid Row

The Ethics of Phase 1 Trials in the Developing World

Bibliographic Data

ID19516327
AuthorsJonathan Kimmelman (0000-0003-1614-6779, McGill University, corresponding author)
Year2007
Volume7
Issue3
Pages128-135
Publication date2007-12-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueDeveloping World Bioethics (JOURNAL)
Journal identifiersISSN: 1471-8731 • E-ISSN: 1471-8847
PublisherWiley (PUBLISHER • GB)
DOI10.1111/j.1471-8847.2006.00154.x
PMID18021117
OpenAlexW4233157419
LanguageEN
References cited24

Relatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied with various international guidelines that require that clinical trials conducted in the developing world be responsive to their populations’ health needs. Nevertheless, policies devised to address large scale, late stage trials, such as the AZT short-course placebo trials, map somewhat awkwardly to early phase studies. I argue that interest in conducting translational research in the developing world, particularly in the context of hemophilia trials, should motivate more rigorous ethical thinking around clinical trials involving economically disadvantaged populations

Clinical trial · Developing country · Disadvantaged · Economic growth · Pathology · Political science · Psychiatry · Research ethics · Biomedical Ethics and Regulation · CRISPR and Genetic Engineering · Ethics in Clinical Research · History · Law · Medicine · Psychology

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