PODCAST: "Clinical Trial Ethics in the Developing World"
Jonathan Kimmelman, Ph.D., Assistant Professor in the Biomedical Ethics
Unit/Social Studies of Medicine Department, McGill University, is
interviewed by GEN's Editor in Chief, John Sterling.
WHEN: August 7 - August 14, 2008
Early-stage gene therapy clinical trials are recruiting patients from
the developing world, providing medically deprived populations with
access to interventions that show promise. The effects of these early
studies on humans, however, 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 this
perceived disparity. 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 a number of key concerns about carrying
out early-stage studies in developing nations, including those involving
gene therapy, versus conducting Phase II and III investigations. He
offers some well thought out advice to companies and scientists planning
to carry out early-stage trials in the developing world.
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