6th Workshop Outline

The 6th 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 National Cancer Center Japan and the University of Texas MD Anderson Cancer Center hosted “The 6th Clinical Research Skill Advancement 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 6th 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-sponsored this workshop. Prior to the workshop, we had 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 was interested in applying to the workshop was creating and submitting a protocol concept sheet which used to evaluate and select the final participants.

The 6th Clinical Research Skill Advancement Workshop: Outline
Supervised by:The University of Texas MD Anderson Cancer Center
Co-Sponsored by:Oncology Education Project Association,
National Cancer Center Japan,
Chugai Pharmaceutical Co., Ltd.,
Daiichi Sankyo Co., Ltd.,
Takeda Pharmaceutical Co., Ltd.,

Under the auspices of Japanese Society of Medical Oncology
Luncheon Seminar sponsored by AstraZeneca K.K.

Supported by: Eli Lilly Japan K.K. and Maruho Co., Ltd.,

Dates:March 16th through March 18th, 2018 (3 days)
Venue:Cross Wave Makuhari (Makuhari, Chiba, Japan)
Target:Up-and-coming investigators/medical doctors who are likely to engage in clinical
Number of participants: 20 people
※Note: Final participants was selected based on the information in the
applications and assignments. Participation fee:30,000 yen
(Participants were 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.

【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
- A study using an off-label or unapproved agent that you would like to conduct and
have started within 2 years.

J-HOPE Secretariat Office: secretariat@jhope.jp