What Students Need To Know About Innovative Designs In Clinical Trials

Clinical trials serve as the gold standard to evaluate the efficacy and safety of tested drugs prior to marketing authorization. Nevertheless, there have been a few challenging issues well noted in traditional clinical trials such as tedious processing duration and escalating high costs among others. To improve the efficiency of clinical studies, a spectrum of expedited clinical trial modes has been designed, and selectively implemented in contemporary drug developing landscape. The randomized controlled clinical trials (RCTs) of sequential 3 phases have been traditionally regarded as an official paradigm during drug development for decades. While phase I study is to define the tolerability, pharmacokinetics and adverse effects, subsequently phase II and then III studies are to examine the therapeutic efficacy in exploratory and confirmatory manners respectively. Although RCTs historically played and are still playing a decisive role in evaluating efficacy and safety of a therapeutic agent prior to the mar