5th Workshop Outline

The 5th Clinical Research Skill Advancement Workshop
“Let’s impact the world by conducting high-quality clinical research.”
- How to successfully develop your career as a clinical investigator –

For execution of physician/investigator-initiated clinical trials using unapproved agents
―Drawing up clinical trial protocols in line with new drug development pipelines ―

 The Oncology Education Project Association, together with the University of Texas MD Anderson Cancer Center and Japanese cancer specialists, is happy to have hosted “The Clinical Research Skill Advancement Workshop” (our 5th workshop). The purpose of the workshop was to train physicians/investigators to equip themselves with the hypothesis building skills necessary for designing clinical trials and to be able to conduct translational research efficiently. In other words, the goal of this workshop was to cultivate the next generation of clinical investigators.
 At this 5th workshop, we aimed at “early clinical trials (phase I or phase II) using unapproved agents and/or off-label drugs,” which are common in physician-initiated clinical studies in the EU and the US. We solicited potential participants for clinical trial concepts using agents including ones in the development pipelines of pharmaceutical companies that co-sponsored this workshop. Prior to the workshop, we had a meeting to present the drugs in the pipelines for potential studies to those who wished to participate in the workshop. After the meeting, those who were interested in applying to the workshop were asked to create and submit a protocol concept sheet (LOI) which was then used to evaluate and select the final participants

The 5th Clinical Research Skill Advancement Workshop: Outline
Supervised by:The University of Texas MD Anderson Cancer Center
Co-Sponsored by:Oncology Education Project Association,
Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd.,
Under the auspices of Japanese Society of Medical Oncology
Supported by; Taiho Pharmaceutical CO., LTD., Maruho Co., Ltd.

Dates:January 13th -15th, 2017 (3 days)
Venue:The Congress-Square Nakano (Nakano-ku, Tokyo, Japan)
Target:Up-and-coming investigators/medical doctors who are likely to engage in clinical
Number of participants: 21 people
※Note: Final participants were selected based on the information given in their
applications and assignments.
Participation fee:30,000 yen
(Participants were are responsible for lodging and transportation expenses.)

Objective:This workshop aims at training next-generation clinical investigators in the
oncology field who can formulate and lead hypothesis-driven clinical research
and disseminate evidence from Japan to the world.

Outcome:Participants will revise their LOIs submitted at the time of application and
finalize a high-quality protocol of their own. Through this experience, they
can learn the protocol development process.
Qualifications & application

Qualifications & application

【Qualifications for Participants】
1. Must have one peer review clinical / translational research paper in English as the first
2. Must have one international poster presentation or oral presentation.
3. Must have a concept for a clinical trial of your interests
4. Ability to communicate in English

J-HOPE Secretariat Office: secretariat@jhope.jp

Co-Chair:Narikazu Boku, M.D., Ph.D. (Chief, Division of Gastrointestinal Medical Oncology,National Cancer Center Hospital)
J. Jack Lee, Ph.D. (Professor, Department of Biostatistics, Division of
Quantitative Sciences, the University of Texas MD Anderson Cancer Center)
Supervisor:Naoto Ueno, M.D., Ph.D. (Professor, Department of Breast Medical Oncology,
the University of Texas MD Anderson Cancer Center)
Nobuyuki Yamamoto, M.D., Ph.D. (Professor, Third Department of Internal
Medicine, Wakayama Medical University)
Masahiro Tsuboi, M.D., Ph.D. (‎Chief and Director, Division of Thoracic
Surgery & Oncology, National Cancer Center Hospital East)
Chiyo Imamura, Ph.D. (Senior Assistant Professor, Department of Clinical
Pharmacokinetics and Pharmacodynamics, School of Medicine, Keio
University) Chandra Bartholomeusz, M.D., Ph.D. (Assistant Professor,
Department of Breast Medical Oncology - Research, Division of Cancer
Medicine, the University of Texas MD Anderson Cancer Center)
Junji Tsurutani, M.D., Ph.D. (Associate Professor,Department of medical
Oncology, Kindai University Faculty of Medicine)

Special Guest:Shigehisa Kitano, M.D., Ph.D. (Department of Experimental Therapeutics,
National Cancer Center Hospital)