Article Abstract

Advanced clinical trials for China

Authors: Richard L. Schilsky


Clinical trials are the primary means through which new drugs and devices are developed for use in patients. Through a series of studies that aim to demonstrate safety, activity, benefit, and effectiveness, clinical trials provide a rigorous scientific methodology for evaluating questions in clinical medicine and advancing new treatments to the marketplace. Clinical trials are also essential to directly compare the effectiveness of various treatment options and to assess the cost and cost effectiveness of new treatments. Clinical trials also provide a context and infrastructure that enables investigators to prospectively collect biospecimens that can be used to answer important questions about the benefits and harms of therapies in subgroups of patients as well as to develop new prognostic and predictive tests.