Ethics and Options in Clinical Trial Design

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You can’t help but be moved by the plight of the patients in Saturday’s NY Times article “New Drugs Stir Debate on Rules of Clinical Trials.” The article caused me to reflect on my role, as a medical device executive, in the design of clinical trials.  The story presents the ethical challenges of a randomized controlled clinical trial (RCT) of a new drug, through the story of two patients in the trial.  The same challenges faced by drug trials also apply to medical device trials.   What are some of the issues and what are some of the options?

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