13th, January, 2022
National Center for Global Health and Medicine
Center for Clinical Sciences
Department of International Trial

The Japan-led International Network for Clinical Researches and Clinical Trials in Asia
"ARO Alliance for ASEAN & East Asia (ARISE)" was established to enhance multicenterinternational clinical research and trials in the Asian region.
Main Point
The Center for Clinical Sciences (CCS), National Center for Global Health and Medicine(NCGM) has established ARISE, an international collaborative clinical research and network, tolay the foundation for the promotion of multi-center global clinical research and trials in Asia.
1. OverviewOn December 9, 2021, National Center for Global Health and Medicine (NCGM) launched the"ASEAN & East Asia International Clinical Research Alliance, ARO Alliance for ASEAN &East Asia (hereinafter ARISE)" to lay the foundation for clinical research and clinical trial
implementation in Asia. ARISE is a network of core clinical research facilities in Asia based on
the cooperative relationships, NCGM has established it in Asia to realize rapid and low-cost drug
and medical device development. The Center for Clinical Sciences, NCGM the Clinical ResearchCenter began this effort with support from the Japan Agency for Medical Research andDevelopment (AMED) (1).
2. Background
Currently, it is difficult to say that Asian countries have sufficient access to pharmaceuticals andmedical devices, including products using innovative technologies. Therefore, it is becoming
increasingly important to contribute to health promotion in Asian countries by improving accessto medicines and medical devices in Asian countries.
Since its establishment in 2016, the Department of International Trial (DIT) of the ClinicalResearch Center (CCS) of NCGM has been working with the Disease Control and Prevention
Center (DCC), Research Institute, and other relevant departments to promote various international
collaborative clinical research and trials. We have implemented "Joint international research

project on measures against antimicrobial drug resistance (AMR) and proper use of antimicrobial
agents in Vietnam" and "Clinical Performance Studies of In-Vitro Malaria Diagnostics andMedical Devices in Thailand and Japan" in cooperation with medical device companies.
In addition, in 2020, we launched the AMED subsidized project, “Clinical research and clinical
trial platform formation to promote international research cooperation between Japan and Asian
countries in the field of infectious diseases.” This project promotes the establishment ofinternational joint research bases and infrastructure in Asian countries, as well as international
joint clinical research and trials in emerging and re-emerging infectious diseases such as COVID19, malaria and tuberculosis.
3. ARISE (Arise) Overview
ARISE, together with Thailand, the Philippines, Indonesia, Vietnam and other countries that are
actively promoting clinical research and development in the Asian region under the leadership ofJapan, will build a network of international joint clinical research and trials, aiming to develop
research and development in the Asian region through physician-led and corporate clinical trials
for pharmaceutical approval applications. We also aim to promote health and reduce diseases anddisabilities. In addition, we will strive to achieve the following missions through efficient andeffective collaboration with member organizations and stakeholders.
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to promote the integrity, safety, ethics, and quality of investigator-initiated clinicalstudies;
to contribute to developing innovative medical products to address unmet health needs
and diseases of public health significance in the region;
to contribute to improving the resources and capacity of clinical study sites in the region;to accelerate clinical studies and improves timelines and processes for authorization;
to promote Public-Academic-Private-Partnerships (PAPPs) in the region; andto bridge the gap between sciences and policy for health.

ARISE was headed by NCGM President Norihiro KOKUDO, and its secretariat office wasestablished within the Center for Clinical Science (Director: Wataru SUGIURA), Department ofInternational Trial (Director: Tatsuo IIYAMA) (Figure 1). At present, 10 organizations in 5
countries are members (Figure 2), and the number of member countries and organizations is
expected to expand gradually.

Figure 1. ARISE Organizational Structure

Figure 2. ARISE member Organizations
The Kingdom

Faculty of Medicine, Siriraj Hospital, Mahidol University (NCGM collaborative officeof Thailand

opened in January, 2021)

The Republic

University of Indonesia (NCGM collaborative office will be open during FY2022)

of Indonesia

Mochtar Riady Institute for Nanotechnology

The Republic

The University of the Philippines Manila（collaborative office opened in January,of the2021）

Philippines

Corazon Locsin Montelibano Memorial Regional Hospital
Manila Doctors HospitalSocialist

Bach Mai Hospital （NCGM collaborative office opened）

Republic ofVietnam
Japan

National Center for Global Health and Medicine (NCGM)
Osaka University
Nagasaki University
International University of Health and Welfare (IUHW)

4. Specific Activities
Currently, we are conducting the following activities with ARISE member organizations.
ARISE plans to further increase the number of international joint clinical studies to carry out theactivities of each working group.
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Development of clinical research infrastructure in ARISE member institutions•On-site research support through the establishment of an NCGM collaboration office(Thailand, Philippines, Indonesia, Vietnam)

•Support for the establishment and strengthening of clinical research centers within NIH inthe Philippines•

On-line and onsite training to strengthen the capacity of clinical research staff (Indonesia,Thailand, Philippines, Vietnam, Democratic Republic of Congo)•

Introduction of standard competencies for clinical research and testing personnel/Survey ofactual competencies (Indonesia, Thailand, Philippines, Vietnam, Democratic Republic ofCongo)•Introduction of EDC, ePRO, eConsent and CTMS, and development of Standard Operating
Procedures (SOP) for efficient global trials②International joint clinical researches conducted with ARISE member organizations andmember countries•

An international study to evaluate the efficacy and safety of antiviral drugs in patients withCOVID-19 (Thailand, Philippines, etc.)•Drug susceptibility testing of clinical isolates (Vietnam)•

Clinical performance tests of malaria drugs and medical devices (Thailand, Japan)•COVID-19 in-vitro diagnostics and medical device clinical performance tests (Vietnam,Indonesia, Philippines)③

ARISE Research Network Cross-Sectional Working Group (WG) Activities (planned)•WG1: Human Resources (HR)•WG2: Public-Academic-Private-Partnerships (PAPPs)•WG3: ARO site management•

WG4: Clinical Data Management•

WG5: R & D Standardization and Harmonization•

WG6: Quality Management④ Holding of various symposiums and workshops (planned)
4. Holding a Kick-Off Meeting
On December 9, the ARISE Kick-off Meeting was held online, with approximately 70 participantsfrom medical institutions in Asia and around the world. At the meeting, presentations were givenon the introduction of the 10 member organizations and the concept and governance of ARISE.
In addition, representatives from the Clinical Research Initiative for Global Health (CRIGH), theEuropean Clinical Research Infrastructure Network (ECRIN) in Europe, and the MRCT Centerof Brigham and Women's Hospital and Harvard (MRCT Center) in the United States presented

their experiences on international collaborative clinical research networks in Europe, the UnitedStates, and the world. We also discussed future activities and international cooperation.

ARISE Kick-Off Meeting on December 9, 2021
5. Future Outlook
International cooperation is essential not only in the field of infectious disease pandemics but alsoin clinical research in the field of rare diseases. As an ARO (2) in the global health field, ARISE
promotes collaboration with major organizations in Europe and the United States, in addition tobuilding alliances in Asia, standardizing operations, and developing human resources, with a view
to pursuing efficiency and quality control in peacetime, and responding quickly in emergencies.
ARISE will continue to work with stakeholders in Japan and overseas to contribute to improving
global health through research and development and the generation of evidence.
★Contact information(ARISE)
National Center for International Medical Research (NCGM)
Clinical Research Center International Trial Department ARISE Secretariat
TEL: 03-3202-7181 (main line), Extension: 2408 * 9: 00 - 17: 00 (weekdays only)
Email: arise@hosp.ncgm.go.jp
ARISE Web site https://ccs.ncgm.go.jp/050/en/capacity_building/arise.html

★References and related Links(1)
Funding Source: Japan Agency for Medical Research and Development (AMED)
Program Name: Clinical Research and Clinical Trials Promotion Project and NetworkDevelopment Project in Asia.
Project Name: Clinical research and clinical trial platform formation to promote international
research cooperation between Japan and Asian countries in the field of infectious diseases(Project Number 20 lk020100j0001)
Principle Investigator: Tatsuo IIYAMA, National Center for Global Health and Medicine(2)
ARO stands for Academic Research Organization. Academic clinical research institute. An
organization that supports clinical and non-clinical research, including drug development, byutilizing the functions of universities, etc., that have research institutes, medical institutions, etc.