“Investigator Initiated Trial (IIT)” has an indispensable role of advancement of medicine, because IITs assume the role of awareness of treatment effectiveness, building evidences for standards therapies and developing new treatments for patients.
IIT has gained name recognition since last year due to repeated media exposure. Unfortunately, the most media coverage was disturbing, and the public is rigorously questioning how an IIT should to be in Japan.
Persons who engage in IIT are required to fully understand the international ethical guidelines and the related regulations in addition to high ethical standards when conducting a research. Currently, IIT is in revolutionary times: guidelines for ethical standards are under amendment. This tutorial session will provide an opportunity to learn the latest regulation, guidelines, and trends of IIT. Targeted audience includes physicians, nurses,pharmacists, and persons in pharmaceutical industry.