ABSTRACT
The goal of the 21st century cures act is to decrease the administrative burdens, encourage innovation and enhance America's healthcare field. Along this line, the 21st century cures act is designed to help accelerate medical product development and bring innovations and advances to patients who need them faster and more efficiently. In addition, the 21st century cures act directs FDA to create one or more inter-center institutes to help coordinate activities in major disease areas between the drug, biologics and device centers which improves the regulation of combination products. Clinical trials utilizing the concept of the master protocol are usually referred to as platform trials, which are to test multiple therapies in one indication, one therapy for multiple indications or both. Wang et al. showed that the bivariate normal model that only considers the individual-level correlation between biomarker and primary endpoint is inappropriate when little is known about how the means of the two endpoints are related.
