January 1, 1970 (Vol. , No. )

John Sterling Editor in Chief Genetic Engineering & Biotechnology News

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.

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