Regulatory Science in Clinical Trials-Challenges of the New Era
New drug, new medical device, and new medical technology should be validated through clinical trials. Especially new drug development needs to go through the phase I, II, III trials, which ends up the ever increasing development budget and leading to higher and higher drug cost. Year 2016 is the year of immunotherapy, and precision medicine is an overwhelming trend. The US National Institute of Health has strong support of investigatorinitiated-trials. National Cancer Institute provided ample funding to oncologic cooperative groups, which leads to change of guidelines and many new drug approvals. The 21st Century Cures Act is a US law enacted by the 114th United States Congress in December 2016. The 21st Century Cures Act called to modify the FDA drug approval process. It was intended to expedite the process by which new drugs and devices are approved by easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs. Where should we go in this new regulatory trend led by the US? New drug regulation need evolution. How to maintain flexibility and scientific stringency in formulation of regulations mandate the stakeholders to collaborate with open and novel thoughts.