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GEN’s editor in chief, John Sterling, interviews life science academic and biotech industry leaders on important research, technology, and trends. These podcasts will keep you informed with all the important details you need.
Early stage gene therapy clinical trials are recruiting patients from the developing world, providing medically deprived populations with access to interventions that show promise. However, the effects of these early studies on humans are largely unknown.
According to commentary by bioethicists at Carnegie Mellon (Alex John London, Ph.D.) and McGill University (Jonathan Kimmelman, Ph.D.) published in the July 5 issue of The Lancet, the practice may be inconsistent with international ethics guidelines on justice.
During this week's GEN podcast, Dr. Kimmelman elaborates on the perceived inconsistency. He also identifies two specific questions surrounding international research that he and Dr. London believe have received scant attention. Dr. Kimmelman discusses why researchers are increasingly looking to the developing world as a source of clinical trial participants and describes some a number of key concerns about carrying out early stage trials in developing nations, including those involving gene therapy, versus conducting Phase II and III trials. He offers some well-thought-out advice to companies or scientists planning to carry out early stage trials in the developing world.
Jonathan Kimmelman holds a PhD in Molecular Biophysics and Biochemistry from Yale, and is Assistant Professor in the Biomedical Ethics Unit / Social Studies of Medicine Department of McGill University. Kimmelman's research centers on the ethics of translational clinical trials involving novel interventions like gene transfer and cell transplantation. Recent publications have appeared in The Hastings Center Report, BMJ, and Lancet; he is presently under contract with Cambridge University Press for a book on the ethics of human gene transfer. Kimmelman serves on the ethics committee of the American Society of Gene Therapy, and is the recipient of the 2006 Maud Menten New Investigator Prize of the Canadian Institutes of Health Research.