Current Edition

Cardiovascular Medical Devices Watch Column

Rick Turner, PhD, Senior Director of Quintiles Cardiac Safety Center of Excellence, writes a column regarding many aspects of developing and bringing medical devices to market that differ from those for drugs, while both medical devices and biopharmaceutical drugs fall under the heading of new medical products. These aspects include the types of preapproval clinical trials conducted and the nature of the regulatory landscapes that have been put in place by regulatory agencies. In new drug development, the classical study design employed in therapeutic confirmatory (Phase III) trials is the randomised clinical trial (RCT).