ncgm国際感染症フォーラムconfidential ©2014 parexel international corp. all rights...

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



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


Number of trials in each of the 58 infectious disease (ID)

subcategories comprising the ID Trials Dataset.

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


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



Indonesia

JAPAN

Vietnam

ThailandPhilippines

日本発の候補治療薬医療機器

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

MULTI-REGIONAL

CLINICAL TRIALS IN

VIETNAM

& BACH MAI HOSPITAL

NGO QUY Chau, MD. PhD. Professor

Vice director of Bach Mai Hospital, HANOI

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

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

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

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



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

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

Regional Multicenter Trial: Thailand

Punnee Pitisuttithum MBBS,DTM&H,FRCP(T)Prof., Faculty of Tropical Medicine, Mahidol

UniversityTokyo 18 OCT 2017

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

© 2016 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL33

TOP INDICATIONS & TRIAL PHASES

Source; Citeline;

01/01/2007 to 01/01/2017

Vaccine Trial Centre

Established in1984

Funded by WHO

on Control of Diarrhea

Diseases

Full operation in1986

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

人口世界第４位２億６千万人

連携協力国


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

Indonesia

JAPAN

Vietnam

ThailandPhilippines

日本発の候補治療薬

EthnicDifference?

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

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

Indonesia

JAPAN

Vietnam

ThailandPhilippines

日本発の候補治療薬

Clinical PharmacologicalPK & PD Profiling

MERS

SARS

エボラ出血熱

新型インフルエンザ

JAPAN

MERS

SARS

エボラ出血熱


JAPAN

国民保護安全保障

JAPAN

MERS

SARS

エボラ出血熱


候補治療薬

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

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

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

Basket Trial Design

Basket trials test the effect of a drug or drugs on one or more mutations in a variety of cancer types.

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

http://journals.sagepub.com/keyword/Platform+Trial

http://journals.sagepub.com/keyword/Master+Protocol

http://journals.sagepub.com/keyword/Multi-arm

http://journals.sagepub.com/keyword/Adaptive

http://journals.sagepub.com/keyword/Bayesian

http://journals.sagepub.com/keyword/Clinical+Trial+Design

Key Issues for Drug and Medical Device Development in South East-Asia Region

Global Regulatory

Ethical Frameworks

Informationand Data Sharing

CapacityBuilding


ncgm国際感染症フォーラムconfidential ©2014 parexel international corp. all rights...

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