3rd Workshop Outline

The 3rd 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 host “The Clinical Research Skill Advancement Workshop,” the 3rd workshop. The purpose of the workshop is 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 is to cultivate the next generation of clinical investigators.
 At this 3rd workshop, we aim 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 solicit the participants for clinical trial concepts using agents including the ones in the development pipelines of pharmaceutical companies that co-host or support this workshop. Prior to the workshop, we will have a meeting to present the drugs in the pipelines for potential studies to those who wish to participate in the workshop. After the meeting, those who are interested in applying to the workshop will be creating and submitting a protocol concept sheet which will be used to evaluate and select the final participants

The 3rd Clinical Research Skill Advancement Workshop: Outline

Supervised by:The University of Texas MD Anderson Cancer Center
Joint host:Oncology Education Project Association, Daiichi Sankyo Company, Limited.,
Shionogi & Co., Ltd., Taiho Pharmaceutical Co., Ltd.,
Supporters:Japanese Society of Medical Oncology, Eli Lilly Japan K.K., Maruho Co., Ltd.

Dates:January 9th-11th, 2015 (3 days)
Venue:Harumi Grand Hotel (Chuo-ku, Tokyo, Japan)
Target:Up-and-coming investigators/medical doctors who are likely to engage in clinical
Number of participants: 30 people (Participant candidates will undergo a selection process.
Guests from Korea and Taiwan will be accepted.)
※Note: Final participants will be selected based on the information in the applications and
assignments. Participation fee:30,000 yen
(Participants 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 the protocol concept sheet 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 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

■How to apply to the workshop
If you would like to participate, please submit the following documents and assignments
including a protocol concept sheet via E-mail attachment to J-HOPE Secretariat office.
Application deadline:November 25th (Tuesday), 2014

【Items required for application】
(1) CV (in English)
(2) Personal statement: “Future career development plan for clinical investigation”
(1 page, in English)
(3) Proof of qualification: abstracts, posters, slides, etc. (in English)
(4) Completed protocol concept sheet of a phase I, II or I/II study
(download Protocol Concept Sheet(Word): in English)
- A study using an off-label or unapproved agent that you would like to conduct and
have started within 2 years.


Narikazu Boku, M.D., Ph.D. (Professor, Department of Clinical Oncology, St. Marianna
School of Medicine)
J. Jack Lee, Ph.D. (Professor, Department of Biostatistics, Division of Quantitative
Sciences, the University of Texas MD Anderson Cancer Center)

Naoto Ueno, M.D., Ph.D. (Professor, Department of 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)
Satoshi Morita, Ph.D. (Professor, Department of Biomedical Statistics and Bioinformatics,
Kyoto University Graduate School of Medicine)
Chiyo Imamura, Ph.D. (Senior Assistant Professor, Department of Clinical
Pharmacokinetics and Pharmacodynamics, School of Medicine, Keio University)

New Faculty Members:
Hideyuki Saya, M.D., Ph.D. (Professor, Division of Gene Regulation, Institute for
Advanced Medical Research, Graduate School of Medicine, Keio University)
Kazuto Nishio, M.D., Ph.D. (Professor and Chairman, Department of Genome Biology,
Kinki University School of Medicine)


J-HOPE Secretariat Office

1-6-12 Nishi Shimbashi, Minato-ku, Tokyo, 105-0003 Japan