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NCGM臨床研究センターの取り組み
NCGM国際感染症フォーラム
臨床研究センター
渡邉裕司
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NCGM臨床研究センターの取り組み
NCGM国際感染症フォーラム
感染症に関する臨床試験の国際情勢
織田記念国際シンポジウムの成果
臨床試験の新たな潮流
NCGM臨床研究センターの取り組み
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NCGM臨床研究センターの取り組み
NCGM国際感染症フォーラム
感染症に関する臨床試験の国際情勢
織田記念国際シンポジウムの成果
臨床試験の新たな潮流
NCGM臨床研究センターの取り組み
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Number of trials in each of the 58 infectious disease (ID)
subcategories comprising the ID Trials Dataset.
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The percentage of selected infectious disease (ID) subcategories
in the ID Trials Dataset as compared with the burden of disease
in the United States and globally.
Goswami ND, Pfeiffer CD, Horton JR, Chiswell K, Tasneem A, et al. (2013) The State of Infectious Diseases Clinical Trials: A
Systematic Review of ClinicalTrials.gov. PLOS ONE 8(10): e77086. https://doi.org/10.1371/journal.pone.0077086
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0077086
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Rank of disease-specific trial frequency vs. disease-
related mortality across eleven world regions.
Goswami ND, Pfeiffer CD, Horton JR, Chiswell K, Tasneem A, et al. (2013) The State of Infectious Diseases Clinical Trials: A
Systematic Review of ClinicalTrials.gov. PLOS ONE 8(10): e77086. https://doi.org/10.1371/journal.pone.0077086
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0077086
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Indonesia
JAPAN
Vietnam
ThailandPhilippines
日本発の候補治療薬医療機器
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疾病傾向や患者数
臨床研究実施機関の実態
医薬品・医療機器承認制度
関連する諸規制
保険償還制度
臨床研究を国際展開するための情報収集
研究者
NCGM国際感染症フォーラム会員
政府機関等情報提供
PMDA
連携
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NCGM臨床研究センターの取り組み
NCGM国際感染症フォーラム
感染症に関する臨床試験の国際情勢
織田記念国際シンポジウムの成果
臨床試験の新たな潮流
NCGM臨床研究センターの取り組み
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MULTI-REGIONAL
CLINICAL TRIALS IN
VIETNAM
& BACH MAI HOSPITAL
NGO QUY Chau, MD. PhD. Professor
Vice director of Bach Mai Hospital, HANOI
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CLINICAL TRIALS IN BACH MAI HOSPITAL
• BMH is one of the largest general hospital,
teaching hospital of Hanoi Medical University.
• 1900 beds. The labs are certified ISO: 15189
• There are 3 institutes, 8 centers, 23 clinical
departments and 6 Para clinical departments.
• Professors and Associate Professor: 42, PhD.MD:
40
• Every day: 4,000 inpatients; 5,000 outpatients
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21
4140
38
42
18
1
5
8
4
2
7
5
9
6
211
23
0
5
10
15
20
25
30
35
40
45
2012 2013 2014 2015 2016 07/2017
Tan duoc
Vacxin
YHCT
PP mới, KT mới
TBYT
THE QUANTITY OF APPROVED CLINICAL TRIALS FROM JAN-2012 TO JUL-2017 IN VIET NAM
- Drugs
- Vaccines
- Traditional medicines
- New technologies
- Medical devices
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Multi-Regional Clinical Trial in the Philippines
6th ODA Memorial International SymposiumMulti-Regional Clinical Trials for Medical
Advancement in Asia: Strategy and CollaborationOct. 18 2017, Tokyo, Japan
SALVACION R. GATCHALIAN, M.D.Associate Professor, University of the Philippines, College of Medicine,
Philippine General Hospital
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Philippines Top 5 Disease Burden Prevalence(Department of Health, Manila, 2017)
• Cardiovascular diseases
• Cerebro-vascular diseases
• Malignant Neoplasms
• Pneumonia
• Tuberculosis
DEMOGRAPHICS
POPULATION102, 624, 209
(#13th in the world)
POPULATION GROWTH RATE 1.59%
AGE STRUCTURE
0-14 years 33.71%
15-64 years 19.17%
25-54 years 36.86%
55-64 years 5.89%
65 years and up 4.38%
MEDIAN AGE 23.4
SEX RATIO
At birth 1.05 male(s)/female
Under 15 years 1.04 male(s)/female
15-24 years 1.04 male(s)/female
25-54 years 1.03 male(s)/female
55-64 years 0.84 male(s)/female
65 years and up 0.72 male(s)/female
Total population 1.01 male(s)/female
LIFE EXPECTANCY 65.7 (male), 72.9 (female) 0 5 10 15 20 25
Diseases of the heart
Diseases of the vascular…
Malignant neoplasms
Pneumonia
Accidents
Diabetes mellitus
Chronic lower respiratory…
Tuberculosis, all forms
Nephritis, nephrotic…
Certain conditions…
Percent
Mortality: Ten (10) Leading CausesPercent Distribution Philippines, 2013
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Philippine clinical trial statisticsTrial phases based on 1,232 studies
2
6
9
19
21
28
161
249
737
0 200 400 600 800
Other
III/IV
(N/A)
I
I/II
II/III
II
IV
III
Number of Clinical Trials [Source: Citeline, Feb 2017]
T r
ia l
P h
a s
e
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Regional Multicenter Trial: Thailand
Punnee Pitisuttithum MBBS,DTM&H,FRCP(T)Prof., Faculty of Tropical Medicine, Mahidol
UniversityTokyo 18 OCT 2017
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CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. /
CLINICAL TRIALS: 2007-2017 (SOURCE: CITELINE AS OF JAN 2017)
32
Top: 10684
Average: 4611
Min: 51
• Total of 1,594 Clinical Trials performed in Thailand
56
78
142
248
263
270
811
858
1,154
1,294
1,594
2,895
4,221
4,860
6,429
9,637
11,595
0 2000 4000 6000 8000 10000 12000 14000
Kazakhstan
Sri Lanka
Bangladesh
Pakistan
Indonesia
Vietnam
Philippines
Malaysia
Hong Kong
Singapore
Thailand
Taiwan
India
Australia
South Korea
China
Japan
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© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL33
TOP INDICATIONS & TRIAL PHASES
Source; Citeline;
01/01/2007 to 01/01/2017
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Vaccine Trial Centre
Established in1984
Funded by WHO
on Control of Diarrhea
Diseases
Full operation in1986
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Past 30Years of Research Experiences
• Cholera Vaccine
Killed whole cell and B sub-unit oral vaccine
CVD103-Hg resistant oral vaccine
• Rotavirus Vaccine- Rotashield (tetravalent oral vaccine)
• Poliomyelitis Vaccine (OPV & IPV)
• Malaria Vaccine Varicella Vaccine
• Measles Vaccine Cholera challenge-O1, O139
• WRSS1 Shigella Vaccine
• HPV quadri-valent vaccine, nona- valent vaccine
• H1N1 LAIV vaccine (WHO) , H5N2 LAIV Vaccine (WHO)-PB
• GPO IIV
• Dengue vaccine –CYD –TV vaccine
• Adjuvanted Influenza vaccine
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人口世界第4位2億6千万人
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連携協力国
臨床研究センター
人材交流情報共有 協働
人材育成
人的ネットワーク形成
海外からの専門人材の受け入れと帰還を循環
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Indonesia
JAPAN
Vietnam
ThailandPhilippines
日本発の候補治療薬
EthnicDifference?
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医事会計システムと連携した多言語対応再来受付機開発による外国籍患者の動向石割、小南、中川、奥村、長澤、山内、美代、橋本、第37回日本医療情報学連合大会
NCGMに登録されている国籍別患者数
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医事会計システムと連携した多言語対応再来受付機開発による外国籍患者の動向石割、小南、中川、奥村、長澤、山内、美代、橋本、第37回日本医療情報学連合大会
初再診の外国籍患者数の推移
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Indonesia
JAPAN
Vietnam
ThailandPhilippines
日本発の候補治療薬
Clinical PharmacologicalPK & PD Profiling
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NCGM臨床研究センターの取り組み
NCGM国際感染症フォーラム
感染症に関する臨床試験の国際情勢
織田記念国際シンポジウムの成果
臨床試験の新たな潮流
NCGM臨床研究センターの取り組み
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MERS
SARS
エボラ出血熱
新型インフルエンザ
JAPAN
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MERS
SARS
エボラ出血熱
新型インフルエンザ
JAPAN
国民保護安全保障
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JAPAN
MERS
SARS
エボラ出血熱
新型インフルエンザ
候補治療薬
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JAPAN
MERS
SARS
エボラ出血熱
新型インフルエンザ
候補治療薬
NCGM国際感染症フォーラム
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緊急救命的治療
貴重な診療データの価値は?
数少ない貴重なデータも承認データとしては
利用不能
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緊急救命的治験
貴重な診療データを有効に活用
数少ないデータを貴重な承認データとして利用可能とする
想定される感染症に対して事前に治験や臨床試験
を計画
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Umbrella Trial Design
Umbrella trials test the impact of different drugs on different mutations in a single type of cancer.
Centralized Biomarker Profiling
BiomarkerA positive
BiomarkerB positive
BiomarkerC positive
BiomarkerD positive
Drug X Drug Y Drug ZDrug W
Single type cancer
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Basket Trial Design
Basket trials test the effect of a drug or drugs on one or more mutations in a variety of cancer types.
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Background:
A “platform trial” is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. Adaptive platform designs offer flexible features such as dropping treatments for futility, declaring one or more treatments superior, or adding new treatments to be tested during the course of a trial.
Methods:
A simulation study explores the efficiencies of various platform trial designs relative to a traditional two-arm strategy.
Results:
Platform trials can find beneficial treatments with fewer patients, fewer patient failures, less time, and with greater probability of success than a traditional two-arm strategy.
Conclusion:
In an era of personalized medicine, platform trials provide the innovation needed to efficiently evaluate modern treatments.
Keywords Platform trial, master protocol, multi-arm, adaptive, Bayesian, clinical trial design
Efficiencies of platform clinical trials: A vision of the future
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NCGM臨床研究センターの取り組み
NCGM国際感染症フォーラム
感染症に関する臨床試験の国際情勢
織田記念国際シンポジウムの成果
臨床試験の新たな潮流
NCGM臨床研究センターの取り組み
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Key Issues for Drug and Medical Device Development in South East-Asia Region
Global Regulatory
Ethical Frameworks
Informationand Data Sharing
CapacityBuilding
臨床研究センター
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