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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

  • Chief Medical Officer, Associate Executive Director
  • Pharmaceutical and Medical Devices Agency, 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.

Speaker(s)

Taro  Shibata, MSc

Oncology Experience

Taro Shibata, MSc

  • Director, Biostatistics Division
  • Center for Research Administration and Support, National Cancer Center, Japan
Yoshiyuki  Majima

Patient View

Yoshiyuki Majima

  • Director
  • PanCAN (Pancreatic Cancer Action Network), Japan
Dalvir  Gill, PhD

Innovative Drug Development: Is The Placebo Arm Really Necessary?

Dalvir Gill, PhD

  • Chief Executive Officer
  • TransCelerate BioPharma Inc., United States
Agnès  Saint-Raymond, DrMed

Agnès Saint-Raymond, DrMed

  • Head of International Affairs Division
  • European Medicines Agency, Netherlands