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Improving Quality of Clinical Trials and Addressing Subjects’ Protection by Encouraging Research and Development of New Drugs 【Date:2018-10-31】 unit:藥品組

Along with encouraging innovation in new drug development Taiwan Food and Drug Administration (TFDA) places a high importance on ensuring and protecting the rights of those patients involved in clinical trials. In order to achieve this TFDA promote a clinical trial training program to ensure compliance with Guidelines for Good Clinical Practice and address the spirit of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In addition, TFDA has also revised Informed Consent Form template and addressed subjects’ protection ensuring their rights and providing clear information to promote awareness regarding the trial.

The TFDA also supports the clinical trial training program yearly which consists of two types of training courses, which are the basic training and the advanced training. The basic training courses focus on fundamental concepts including Good Clinical Practice, research ethics, and quality of trials. The advanced training courses focus on further learning and discussion for specific topics, such as “Early Phase Clinical Trial for Drug Development” and “the Implementation of Monitoring Clinical Trials”. The subjects’ protection activities focus on the correct concepts for clinical trials as well as the rights and responsibilities of the subjects. The approaches include lessons and adventure games to introduce basic concepts of clinical trials to the publics.

In the future, TFDA plans to establish an online learning system for helping more people understand clinical trials and the rights of those involved. In the meantime, TFDA will continue to perfect the environment of clinical trials and strengthen the protection of subjects.