title: Clinical trials and SCID row: the ethics of phase 1 trials in the developing world.
abstract: 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.
authors.affiliation: Department of Social Studies of Medicine, Clinical Trials Research Group/Biomedical Ethics Unit, McGill Faculty of Medicine, Montreal, Canada. jonathan.kimmelman@mcgill.ca
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kimmelman
mesh_terms: D000243:Adenosine Deaminase / Q000172:deficiency / Q000235:genetics / Q000627:therapeutic use; D000349:Africa; D019380:Anti-HIV Agents / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic / Q000941:ethics*; D003906:Developing Countries; D032984:Ethics, Research; D018014:Gene Transfer Techniques / Q000941:ethics; D015316:Genetic Therapy / Q000941:ethics*; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission; D006467:Hemophilia A / Q000235:genetics / Q000628:therapy; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D007558:Italy; D011203:Poverty; D016511:Severe Combined Immunodeficiency / Q000235:genetics / Q000628:therapy*; D016896:Treatment Outcome; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D015215:Zidovudine; D000243:Adenosine Deaminase