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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S44] Innovative Drug Development: Is the Placebo Arm Really Necessary?

Session Chair(s)

Haruko  Yamamoto, MD, PhD

Haruko Yamamoto, MD, PhD

Director, Department of Data Science

National Cerebral and Cardiovascular Center, Japan

Since long ago, clinical trials have been conducted using a placebo arm in drug development. The meaning of setting the placebo arm as the theory of clinical trial design is well established and understood among those involved in drug development. On the other hand, it is also a fact that the clinical trial sites or patients have a sense that “it is difficult to conduct a trial with a placebo arm”, “does not want to receive a placebo”, which makes difficult to conduct the clinical trials. In this session, we asked the question, “Is the placebo arm really necessary?”, Referring to the state of the anticancer drug, and receiving opinions from doctors, patients, industries, and regulators in Japan and overseas viewpoints, discuss the possibility of clinical development without putting placebo arm.


Taro  Shibata, MSc

Oncology Experience

Taro Shibata, MSc

Center for Research Administration and Support, National Cancer Center, Japan

Chief, Biostatistics Division

Yoshiyuki  Majima

Patient View

Yoshiyuki Majima

Rare Cancers Japan, Japan


Dalvir  Gill, PhD

Innovative Drug Development: Is The Placebo Arm Really Necessary?

Dalvir Gill, PhD

TransCelerate BioPharma Inc., United States

Chief Executive Officer

Agnès  Saint-Raymond, DrMed

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

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