2nd Workshop Outline

The 2nd 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 2nd workshop followed by the one held last year. 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 2nd 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 2nd Clinical Research Skill Advancement Workshop: Outline

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

Dates:January 10th-12th, 2014 (3 days)
Venue:Harumi Grand Hotel (Chuo-ku, Tokyo, Japan)
Target:Up-and-coming investigators/medical doctors who are likely to engage in clinical research.
Number of participants: 21 people(Participant candidates will undergo a selection process.
Guests from Korea are accepted.)
※Note: Final participants will be selected based on the protocol concept sheet.
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 (Monday) 2013

【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:
>> A paper you have written on a clinical trial that has been published in an
International journal.
>> Presentation slides or a poster or an abstract about a clinical trial that you have
presented to an international congress.
(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.
(5) Regarding the pipeline from Japanese pharmaceutical companies;
1) Co-hosting and sponsoring pharmaceutical companies will give the presentation
slides about their pipelines.
2) If you would consider using their pipeline, we would much appreciate it. If that is
the case, you need to submit a confidentiality agreement before you receive
the presentation slides.


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

Naoto T. Ueno, M.D., Ph.D., F.A.C.P. (Professor of Medicine, Department of Breast Medical
Oncology, Division of Cancer Medicine, The University of Texas MD Anderson
Cancer Center)
Masahiro Tsuboi, M.D., Ph.D. (Associate Professor, Division of Thoracic Surgery,
Respiratory disease Center, Comprehensive Cancer Center, Yokohama
City University Medical Center)
Nobuyuki Yamamoto, M.D., Ph.D. (Professor, Third Department of Internal Medicine,
Wakayama Medical University, School of Medicine)
Satoshi Morita, Ph.D. (Professor, Department of Biomedical Statistics and Bioinformatics,
Kyoto University Graduate School of Medicine)
Chiyo k. Imamura, Ph.D. (Senior Assistant Professor, Department of Clinical
Pharmacokinetics and Pharmacodynamics, School of Medicine, Keio University)


J-HOPE Secretariat Office

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