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Authors

Christine Grady

Abstract

Sam Jones has agreed to participate in a clinical trial testing an experimental drug as a possible treatment for his chronic disease. The primary outcome of effectiveness is a decrease in a specific disease marker after two months of taking the drug. Soon after Sam begins to take the drug, he reports feeling better and the level of disease marker in his blood is significantly lower at each study interval. The study reaches its predetermined endpoint, is stopped as planned, and the sponsor submits an application to a regulatory agency to license the drug for this indication. It is clear that Sam would clinically benefit from continuing to take the drug.

Is it the responsibility of the investigator or the research sponsor to ensure that Sam and other participants in this study continue to receive the drug or even to provide it to them after a study ends? This question is at the heart of recent controversy regarding post-trial benefits and may be one of the biggest ethical challenges facing clinical investigators, especially those involved in international research, over the next several years.

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