京都大学医学部附属病院 探索医療センター検証部
			  Div. Clinical Trial Design & Management, Translational Research Center, Kyoto University Hospital
Kyoto Unv.

Kyoto Unv. Hospital
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がん情報サイト Cancer Information Japan
Aim of Establishment of the Department
The Translational Research Center at Kyoto University Hospital (hereafter TRC) was founded in October 2001 to develop innovative medicine. The mission and goal of TRC are to accelerate therapeutics innovation and to improve therapeutic outcome of intractable disorders.

TRC consists of three divisions, Department of Experimental Therapeutics, Department of Clinical Trial Design & Management and Department of Clinical Innovative Medicine. Department of Trial Design & Management was established in December 2001 to support clinical studies, focusing on protocol development and strategic clinical trials (Phase I to III).

Masanori Fukushima MD, PhD, Medical Oncologist, is the professor and chairman of this department.



Staff
(2008.5.16)
Professor
Masanori Fukushima, MD, PhD (Kyoto Univ.)
Specialty: Medical Oncology
Design & Management of Clinical Trial

Associate Professor
Satoshi Teramukai, PhD
Specialty: Biostatistics
Clinical Trial Methodology

Assistant Professor
Harue Tada, MPH, RN
Specialty: Pharmacoepidemiology
Design & Management of Clinical Trial

Miyuki Niimi, PhD, RN
Specialty: Clinical Trial Methodology
Data Management

Kenichi Yoshimura, PhD
Specialty: Biostatistics

Keiichi Yamamoto
Specialty: Medical Informatics
 
Emiko Doi
Specialty: Design & Management of Clinical Trial
 
Rie Onodera, MS
Specialty: Design & Management of Clinical Trial
Regenarative Medicine

Shiro Tanaka, PhD
Specialty: Biostatistics


Pharmacist
Chihiro Suzuki

Medical Technician
Mihiro Sugiura

Nurse
Nanae Seo

Researcher
Yoko Teraguchi

Technical Assistants
Naoki Eguchi
Asakazu Ogasawara
Yukari Nishida

Secretary
Rika Shimoyama

Graduate Students
Bin Zhou, MD
Tsutomu Nishimura, RN
Yusuke Kishida, MD
(Gastrointestinal Surgery)
Koya Hida, MD

Research Students
Keiko Murata, Pharmacist
Kotone Matsuyama, Pharmacist
Shinsuke Kojima, MD
Takashi Yamamoto, Pharmacist



Activities
(2006.4.1)
We take strategic approaches for clinical development of new drugs and devices. Ongoing Studies are as following table;

Department of Trial Design & Management: Investigator-Sponsored Clinical Studies
 


No Study Type Investigator Institution Status
1 Ghrelin Phase I Prof. Kangawa Kyoto Univ.,
TRC
Closed
2 Ghrelin for FD Phase II Prof. Kangawa Kyoto Univ.,
TRC
Ongoing
3 Ghrelin for OA Phase II Prof. Kangawa Kyoto Univ.,
TRC
Ongoing
4 HGF Phase I / II Prof. Tsubouchi Kyoto Univ.,
TRC
Ongoing
5 ONO-4819・CD for UC Phase II Prof. Narumiya Kyoto Univ.,
TRC
Ongoing
6 AMD Outcomes Assoc.Prof.
Takahashi
Nationwide Ongoing
7 UFT/GEM for NSCLC Phase I Prof. Wada Kyoto Univ. Closed
8 BMCT for AMI Phase I / II Assoc.Prof.
Kimura
Kyoto Univ. Ongoing
9 bFGF for BB Phase I / II Prof. Komeda Kyoto Univ. Ongoing
10 bFGF for PA Phase I / II Prof. Komeda Kyoto Univ. Ongoing
11 Leptin for LADM Phase II Prof. Nakao Kyoto Univ. Ongoing
12 HBV for LT Phase II Prof. Tanaka Kyoto Univ. Ongoing
13 DST for LT Phase II Assoc.Prof.
Koshiba
Kyoto Univ. Ongoing
14 AM for PC Phase II Prof. Ogawa Kyoto Univ. Ongoing
15 TCC/Cystectomy Outcomes Prof. Ogawa Nationwide Closed
16 Lympho Edema Outcomes Assoc.Prof.
Sasaki
Nationwide Closed
17 Ovarian Ca. Outcomes Prof. Ochiai Nationwide Closed
18 Suresample for Endometrial Ca. Outcomes Assoc.Prof.
Sasaki
Tokyo Area Ongoing
19 Lung Ca. Outcomes Prof. Wada Nationwide Closed
20 CRT for LC Outcomes Prof. Mishima Nationwide Closed
21 Renal Cell Ca. Outcomes Prof. Ogawa Nationwide Ongoing
22 Renal Cell Ca. Outcomes Prof. Manabe Nationwide Ongoing