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1 Translational Research Informatics Center ANNUAL REPORT
2 TRIは トランスレーショナルリサーチから 医師主導治験 臨床研究を総合的に支援 推進し 難治性疾患の予後向上に貢献します 臨床研究情報センター Translational Research Informatics Center TRI は アカデミアにおける初めてのデータセンター 解析センターとして 2002 年に文部科学省と神戸市によって創設されました 臨床研究を主導するすべての研究者と医師に対して 研究相談を受け付け 計画の策定から解析 論文化まで一貫して支援しています これまでに受託した 253 件の事業を通して蓄積されたノウハウと経験 パイプラインを活かし トップレベルの専門家チームによる包括的な支援のもと 高品質なプロトコル開発やデータマネジメント きめ細やかなプロジェクト管理や知財戦略策定 満足度の高い論文作成など 信頼いただけるサポートを提供します TRI は 様々な技術革新 基盤整備 科学創成を進め わが国の臨床研究 臨床試験の一層の発展を通じて 国民の健康の向上に貢献します
3 ご挨拶... 2 ＴＲＩ研究事業部門紹介 CONTENTS TRI 研究事業部門紹介... 3 TRIとは... 4 サイエンスセクレタリー室 研修 文書管理室... 6 監査部... 7 企画 広報部... 8 事務サービス部 財務 契約部... 9 eクリニカルソリューション部 医療開発部 プロジェクトマネジメント部 モニタリング部 データ管理部 ＴＲＩの活動と実績 事業開発部 医学統計部 TRIの活動と実績 トランスレーショナルリサーチの推進 管理 1.革新的医療技術創出拠点プロジェクト 一般社団法人ARO協議会 臨床試験と大規模コホート研究の推進 管理 運営 1.研究相談サービスの実施 研究支援サービスと主な成果 国際共同臨床試験 AMED日本主導型グローバル臨床研究整備事業 資料編 3.研究を支える主なシステム 医療 臨床研究情報の発信 1-1.ウェブサイト 臨床研究情報 ウェブサイト 医療情報 シンポジウム 出版 印刷物 広報活動 資料編 組織概要 基本データ Publications 各種申込書 研究相談申込書 研究支援申請書 TRI Annual Report 各種申込書 支援実績一覧... 48
4 TRI2713 funding agency AMED AROAcademic Research Organization TRI 2007 PDCA TRI 800 Global Big Pharma Bench Bed disruptive innovation 14 Check Point Inhibitor AMED Management science for science TRI ARO Asia ARO 43 1ARO Workshop TRI 6272nd World Centenarian Initiative rd World Centenarian Initiative ALS innovation TRI 2 TRI Annual Report 2015
5 TRI Annual Report TRI
6 TRI Translational Research Informatics Center TRI 15 Translational Research Informatics Center: TRI TRI TRI Mission Goal Approach III I II I-II TRI TRI TRI Annual Report 2015
7 TRI Annual Report ep.06 P.06 P.07 P.08 P.09 P.09 P.10 P.11 P.12 P.14 P.14 P.15 P.15 PDQ NCCN Online e-clinicaledc ER/ESPart11CDISC CRF TRI
8 1 Office of Science Secretary SS 1 27TOPICS TRI AMED AMED 9TR TRI AMED 2 Office of Training and Document Managemen TD TRI 27TOPICS SOP TRI 2739 TRI 47TRI FDA PMDA SOP TRI QMSQuality Management SystemSOP GCP 6 TRI Annual Report 2015
9 TRI Annual Report Division of Audit QA TOPICS PolicySOP TRI PDCA QMS SOP
10 4 Division of Strategic Alliance SA 1 2 Clinical Trials.gov TOPICS TRI Strategic AllianceTRI TRI NCCN PDQ TRI TRI PDQ NCCN CDISC 8 TRI Annual Report 2015
11 TRI Annual Report Division of Study Administrative Office SO TRI 27TOPICS TRI 6 Division of Finance & Contract Control FCC TRI3 27TOPICS TRI COIConflict of Interest3 TRI TRI CRO SMO
12 7 Division of Business Development BD ICR Integrative Celerity Research 1 AMED TOPICS TRI Disruptive Innovation QMS 27 AMED 10 TRI Annual Report 2015
13 TRI Annual Report e Division of eclinical Solutions ecs 1 IT 2 3 IT 4 5 IT 6 7 IT EDCElectronic Data CaptureSDTM 2 EDCSDTM 3 eclinical Base 4 EDCSDTM TOPICS 27EDC eclinical Base SDTM-Mapper SDTM-Mapper eclinical Base eclinical Base CDISC/ SDTM eclinical Base SDTM- Mapper define.xml DDFine
14 G G G G G G ICR ICR TOPICS 1 26 QC 2 ICR ICR 12 TRI Annual Report 2015
15 TRI Annual Report ICR 27 AMED CRC 3 Division of Medical Innovation MED 4 5 Cell Processing Center
16 10 Division of Project Management PM TOPICS 11 Division of Monitoring MTG 1 2 Risk-Based Monitoring 27TOPICS Risk-Based Monitoring ICH-GCP 14 TRI Annual Report 2015
17 TRI Annual Report Division of Data Management Clinical Data Management 1 CDISC 2 3 Case Report FormCRFCRF 4 CDISC 5 EDCUser Acceptance TestUAT DM 1 2 CRF 3 EDC 4 5 SAE 1 MedDRAWHO-DD TOPICS 27 CDISC CRF
18 13 Division of Medical Statistics STAT SOP 4 CDISC/ADaM 5 CDISC/ADaM 27TOPICS TRI182,000 Stage SACURA ASCO TRI26 HPPAsfotase AlfaALXN TRI Annual Report 2015
19 TRI Annual Report TRI
20 TRI TR TR 3 TR 1 1 R&D TRI Annual Report 2015
21 1 20 GxP LO % 100 % AMED AMED AROAcademic Research Organization 1020 PD/PS/POAMED 2ARO CROContract Research OrganizationSMOSite Management Organization TRI Annual Report
22 QMS ARO 34 ER/ES, Part11 CDISC ectd R&D Disruptive Innovation 15 4 AMED AMED AMED AMED 5AMED PD/PO AMED TR TR 3 ARO Phase IRB PK/PD GMP GMP GLP/Non-GLP IRB EDC GCPER/ES CDISC SDV SDV SOP CPC 20 TRI Annual Report 2015
23 4 No. PCT PCT FIH 10 FIH 11 FIH FIH 15 FIH TRI Annual Report
24 TRI Annual Report 2015
25 A66 B63 C X CT LASEREO NUU PD PDT CS TRI Annual Report
26 3 R&D 28 QMS TRI ECRINEuropean Clinical Research Infrastructure Network NCATSNational Center for Advancing Translational Sciences HAL Disruptive Innovation Disruptive Innovation Disruptive Innovation 1 ARO TRI TRI 19 TRI QMS TRIECRIN 24 TRI Annual Report 2015
27 2. ARO TRI ARO ARO ARO CPC 1 CDISC 1 PM in OSAKA CDISC End-to-End EUECRINNCATSUS 31 29PMDA Asian TRCenter Workshop ectd CDISC ARO TRI 528 ARO 2 Taiwan-Japan Academic Research Organization Workshop TRI Annual Report
28 TRI 02 1 TRI TR AMED ARO PD/PS/PO TRI Annual Report 2015
29 53%State of the Art 10%2TRI 2 5.0% 15.0% 16.7% 10.0% 53.3% % 19.4% 25% % 13.4% 16.4% 19.4% 4 TRI 4 / 3.4% 2.3% 1.1% / 1.1% 5.0% 8.6% 25.1% / 6.9% 12.6% 10.3% 10.9% 12.6% TRI Annual Report
30 TRI 2718 TRI TRI TRI Annual Report 2015
31 3 TRI EDC eclinical Base 2770 eclinical Base 26SDTM-Mapper EDC CDISC SDTM CRF CDISC SDTM 30CDISC 2425 CRF eclinical Base R&D AMED TRI Annual Report
32 JIROS 25 JIROSJapan Integrated Research Oversight SystemeIRBElectronic Institutional Review Board NIHNational Institutes of HealthASSIST eirb IRAS TRI eclinical Base AMED R&D 27eIRB eirb TRI 28eClinical Solution 4 AMED AMED 24 TRIEDC eclinical Base 1 ARO ARO TR st Taiwan-Japan ARO workshop TR ARO 2832 Asian TR center workshop Asia ARO Network European Clinical Research Infrastructure NetworkECRIN ECRIN 2 Duke Clinical Research Institute TRI QMS ARO ARO ARO 30 TRI Annual Report 2015
33 eirbasan Medical Center eirb Seoul National UniversitySamsung Medical Center eirb TRIeIRB QMS QMS CDISC End-to-EndARO ARO CDISC 1 N/A N/A N/A N/A N/A N/A N/A N/A MCI N/A N/A N/A N/A MCI SJS N/A N/A N/A N/A N/A N/A UK N/A /11 9 B B N/A TRI Annual Report
34 TRI TRI TRI TRI TRI TRI276 TRI 32 TRI Annual Report 2015
35 TRI TRI TRI 1-2 NCCN NCCN NCCN Clinical Practice Guidelines in Oncology TM 25 NCCNNational Comprehensive Cancer Network TRI 22NCCN NCCN NCCN NCCN TRI Annual Report
36 31 27 NCCN / L TRI Annual Report 2015
37 PDQ 17TRI National Cancer Institute; NCI 135 PDQ 27 PDQ NCCN PDQ TRI PDQ PDQ TRI NIA Alzheimers Disease Education and Referral Center; ADEAR NIA ADEAR National Institutes of Health; NIHNational Institute on Aging; NIA1990 ADEAR NIA TRI Annual Report
38 NCCN TRI CentenarianWorld Centenarian Initiative World Centenarian Initiative ALSAmyotrophic lateral sclerosis: World Centenarian Initiative 3 TRI 27 No. 1 2nd World Centenarian Initiative International Symposium on Alzheimers Disease Prevention Strategy -In Search of the Road to New Horizon () TRI 2 1in () 3 3rd World Centenarian Initiative International Symposium on Amyotrophic Lateral Sclerosis -Giving new hope: novel therapies toward a cure- ALS QOL () ALS Amyotrophic lateral sclerosis TRI 4 Asian Translational Research Center Workshop Life-Science Innovation Infrastructure and Activity in Asia 28 32() Life-Science Innovation Infrastructure and Activity in Asia AMED () 33() AMED No.45AMED 36 TRI Annual Report 2015
39 No.1 2nd World Centenarian Initiative International Symposium on Alzheimers Disease Prevention Strategy -In Search of the Road to New Horizon- AD AD MCIA AD MCI AD MCI/AD MCI Opening remarks Masanori Fukushima Translational Research Informatics Center, Japan Keynote Address :00-17:30 JA JA 222 New Orange Plan and Dementia Prevention in Japan Koji Miura Ministry of Health Labour and Welfare, Japan Session IClinicopathology of AD Pathological aspects of amyloid burden in AD Hiroshi Mori Osaka City University, Japan; Tamiya Hospital, Japan Clinicopathological correlation in Alzheimers disease Raj Kalaria Newcastle University, UK Session IIApproaches for risk assessment of AD Japan Community-based study for identifying risk factors of Alzheimer's disease Takashi Asada Tokyo Medical and Dental University, Japan Community-based prevention of dementia in Japan Takao Suzuki J.F. Oberlin University; National Center for Geriatrics and Gerontology, Japan Prevalence and progression of mild cognitive impairment: the Shanghai Aging Study Ding Ding Fudan University, China 2 4% 4% 6% 4% 11% 6% 3% 63% TRI Annual Report
40 Session IIIApproaches for early detection of AD How imaging and biofluid biomarkers are used for clinical trials: The Alzheimer's Disease Neuroimaging Initiative ADNI. Michael Weiner University of California San Francisco, USA Brain imaging on Alzheimer's disease Hidenao Fukuyama Kyoto University, Japan Novel imaging biomarker for early detection of AD Gen Sobue Nagoya University, Japan Imaging of A-linked brain milieu disruption Yasuomi Ouchi Hamamatsu University School of Medicine, Japan Session IVClinical trials for prevention and treatment of AD Strategies for Prevention of AD: Clinical Trials Considerations Rachelle S. Doody Baylor College of Medicine, USA Practical points in conducting clinical trials on Alzheimers disease Jae-Hong Lee Asan Medical Center, Korea Strategy to tackle MCI: a drug repositioning approach Masafumi Ihara National Cerebral and Cardiovascular Center, Japan Current and potential status of clinical trials for MCI and dementia in Asia Christopher Chen Memory Aging and Cognition Centre, National University of Singapore General Discussion Closing remarks 38 TRI Annual Report 2015
41 No.2 1 in :00-16: Muse TRI Annual Report
42 No.3 3rd World Centenarian Initiative International Symposium on Amyotrophic Lateral Sclerosis -Giving new hope: novel therapies toward a cure- ALS QOL Amyotrophic Lateral Sclerosis ALS ALS 49 11ALS 27 ALS F TRI Annual Report 2015
43 Opening remarks Shigeki Kuzuhara Suzuka University of Medical Science 3% 2% 4% Keynote Address 6% Perspectives on therapeutic research for ALS Gen Sobue Nagoya University Session IRisk assessment, early detection and prognosis of ALS 15% 52% Clinical Features of ALS according to the Japanese National Registry for Intractable and Rare Diseases Yoko Sato National Institute of Public Health Neuroimaging for early diagnosis of ALS Makoto Sasaki Iwate Medical UniversityDiscussion 17% Session IIDevelopment of novel therapeutics for ALS The role of ALS Patient Associations in funding and facilitating clinical research Brian Dickie Motor Neurone Disease Association, UK Development of specific therapy for sporadic ALS Shin Kwak The University of Tokyo Preliminary investigation of safety and efficacy of fasudil in subjects with ALS Dongsheng Fan Peking University, CHINA Immune-inflammatory modulation as a therapeutic strategy of stem cell therapy in ALS Seung Hyun Kim Hanyang University, KOREA Regenerative therapies for ALS using hepatocyte growth factor Naoki Suzuki Tohoku University Overview of the US Clinical Trials for ALS - What can we learn from them? Haruhiko Banno Massachusetts General Hospital / Harvard Medical School, USA Session IIIRobotic rehabilitation and Brain-Machine Interface for ALS Brain-machine interface for ALS patients Toshiki Yoshimine Osaka University Cybernic neurorehabilitation using Hybrid Assistive Limb HALfor the patients with neuromuscular disease Takashi Nakajima Niigata National Hospital Closing remarks TRI Annual Report
44 3 MSD MSDThe MSD Manual Merck & Co., Inc., Kenilworth, N.J., U.S.A TRI 24 10TRI 28MSD 42 TRI Annual Report 2015
45 4 TRI TRI TRI TRI ecbeclinical Base TRI News Letter TRI TRI ALS TRI 3 ARO TRI TRI ARO ARO TRI TRI News Letter TRI Annual Report
46 nd World Centenarian Initiative in NCCN NCCN 3rd World Centenarian Initiative ALSQOL PDQ 2 0 ARO ARO ARO CDISC / ectd / QMS / Center-Monitoring 825 ARO 3ARO TRI TRI DIA TRI Annual Report 2015
47 TRI Annual Report
48 Translational Research Informatics Center, Foundation for Biomedical Research and Innovation 154 URL 7,300m TRI H14 H15 H16 H17 H18 H19 H20 H21 H22 H23 H24 H25 H26 H TRI Annual Report 2015
49 TRI Annual Report H15 H16 H17 H18 H19 H20 H21 H22 H23 H24 H25 H26 H H15 H16 H17 H18 H19 H20 H21 H22 H23 H24 H25 H26 H27 61, , , , , , , , , , , , ,468 28,183 50, ,130 36, ,689 26, , , , , , , , , , , , , , , , ,384 88,968 1,305,116 59, , , , , , ,994 1,240,664 1,571,975 1,474,071 1,586,369 1,464,643 1,169,653 1,775,938 1,283,805 76, , , , , , , , , , , , ,236 21,462 22,132 87,227 54, ,720 61, ,598 89, ,238 75, , , , , , , , , , , , , , , , , , , , , ,300 1,191,979 1,263,987 1,017, ,471 1,184,454 1,121,099 1,713,977 1,174,242 19,062-30,020 31,305 29,723 33,693 48, , , , ,189 48,554 61, ,563 5,928 12,176 24,266 23,131 22,556 19,235 27,697 30,440 23,056 27,023 28,326 61,378 28,194 13,134-42,195 7,039 6,591 11,137 29, , , , ,166 20, , H15 H16 H17 H18 H19 H20 H21 H22 H23 H24 H25 H26 H27 0 H15 H16 H17 H18 H19 H20 H21 H22 H23 H24 H25 H26 H27
50 48 TRI Annual Report 2015 ID Phase ID Phase ID Phase ID Phase 2015
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65 TRI Annual Report Publications
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