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?
Yesterday, Consumers Union published quality rankings of 221 of 1,100 cardiac surgery programs in the US. If you haven’t already, I encourage you to read the New England Journal of Medicine and New York Times coverage. The underlying data come from a clinical registry developed by the Society of Thoracic Surgeons, and managed by Duke Clinical Research Institute. I expect to see registries used more commonly for the clinical, regulatory and market development of new medical devices.