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[Student Session] Clinical Trial Protocol Development
Session Chair(s)
Maori Ayabe
Undergraduate Student, Faculty of Pharmaceutical Sciences, Chiba University, Japan
Shouhei Iimura
Student, Keio University, Japan
Aya Okada
Pharmacovigilance, ASKA Pharmaceutical Co., Ltd., Japan
Miho Sato
Undergraduate Student, School of Pharmacy, Showa University, Japan
Clinical trials are essential for evaluating drug safety and efficacy. Moreover, consideration of subjects and choices such as trial designs and evaluation methods are important in conducting them. Therefore, how are ethical and scientific clinical trials designed? This session will provide a lecture on the essence of developing a clinical trial protocol. Subsequently, you will conduct a protocol development by group work and improve understanding. Through active discussion, we would like you to experience the drafting process of a trial plan. In addition, it is desirable to read the following reference because we will deal with antidiabetic drugs as materials for group work: Ministry of Health, Labour and Welfare. “Guideline for Clinical Evaluation of Oral Hypoglycemic Agents”. https://www.pmda.go.jp/files/000208194.pdf, (accessed 2017-05-23).
Speaker(s)
Hideki Mizusako
Clinical Development Department, Daiichi Sankyo Company, Limited, Japan
Points to Consider for Developing Clinical Study Protocol - Based on the Experience and Actual Cases -
Yuka Sakagami
Reviewer, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan