Clinical Trials Center keywords：Clinical Trial, Minimally Invasive Intervention for Cancer, Metabolism and Endocrinology, Precision Medicines for Acute Kidney Disease, Phase I Cancer Clinical Trials, Immune Cell therapy, Taiwan Clinical Trial Consortium for Gastrointestinal Disease and Helicobacter, Taiwan Breast Cancer Consortium, Taiwan Clinical Trial Consortium for Liver Diseases, Taiwan Clinical Trial Consortium for Pediatric Infectious Diseases, Taiwan Lung Cancer Clinical Trial Consortium, Taiwan Clinical Trial Consortium for Adult Infectious Diseases, Taiwan Clinical Trial Consortium for Cardiovascular Disease The National Taiwan University Hospital Clinical Trials Center (hereinafter referred to as the "Center") was established in 2001 with the goal of actively connecting Taiwan and the global clinical trials research industry. It is dedicated to advancing translational medicine in Taiwan and enhancing the biomedical technology capabilities by introducing new clinical treatment techniques to provide hope for patients. In 2022, the National Taiwan University Hospital joined the first group of 20 research hospital partners in the Merck Global Clinical Site Partnership (CSP) program. This partnership aims to engage with top global clinical research experts through relevant research forums, with the expectation of greatly benefiting prospective clinical trial technology in Taiwan, the development of international cutting-edge clinical medical talent, and staying synchronized with international drug development trends. Currently, collaborations are underway with several prominent prospective clinical trials research alliances worldwide, showcasing the Center's transition from its traditional industry-sponsored clinical trial model to participating in important global prospective clinical trials research and development models. At this critical moment in the transformation of clinical trials in Taiwan, the Center will align with the goals and content of the "Clinical Trials Excellence Program" for the years 2025 set by the Ministry of Health and Welfare. Building on the achievements of participating in the Ministry of Health and Welfare's multi-phase development of excellent clinical trials centers, the Center will consider the needs of drug, medical device, and biotechnology medical development, and develop strategies for diversified emerging and distinctive strengths. This includes planning five clinical trial institute-level teams within the Clinical Trials Center (CTC), including (1) Minimally Invasive Intervention for Cancer, (2) Metabolism and Endocrinology, (3) Precision Medicines for Acute Kidney Disease, (4) Phase I Cancer Clinical Trials, and (5) Immune Cell Therapy. Additionally, within the Taiwan Specific Disease Clinical Trials Collaboration (TCTC), the Center plans to operate a collaboration alliance for specific diseases with over four years of experience, led by the National Taiwan University Hospital across medical systems. It includes seven major disease alliance teams in Taiwan, namely (1) Taiwan Gastrointestinal Disease Clinical Trials Collaboration, (2) Taiwan Breast Cancer Clinical Trials Collaboration, (3) Taiwan Liver Disease Clinical Trials Collaboration, (4) Taiwan Pediatric Infectious Disease Clinical Trials Collaboration, (5) Taiwan Lung Cancer Clinical Trials Collaboration, (6) Taiwan Adult Infectious Disease Clinical Trials Collaboration, and (7) Taiwan Cardiovascular Disease Clinical Trials Collaboration. The Center will integrate ongoing inter-ministerial clinical trial program projects, avoid duplication of program projects, establish a sound data governance oversight mechanism, and expand research capabilities and international collaboration through collaboration and development in different fields. This project leverages the advantages of the National Taiwan University Hospital Integrative Medical Data Center (NTUH-iMD) within the Taiwan University Health System and conducts feasibility studies using digital health technology (DHT) to collect subject data. This includes research on (1) types of drug interactions and their impact on blood drug concentrations, (2) analysis of disease-related treatments and prognosis, and (3) research involving artificial intelligence and machine learning. It also assists the research teams in the CTC and TCTC groups in conducting real-world evidence (RWE) studies using real-world data (RWD). The Center has a well-established organizational operation system and support or oversight mechanisms, including dedicated physicians and 30 management professionals, organized into teams such as Investigational Medicinal Products, Clinical Trial Auditing, Clinical Trial Collaboration and Consultation, Clinical Trial Units, Phase I, Clinical Trial Specialization, Medical Device Trials, Contract Review, and Talent Training. This project aims to develop new forms of industry-academic collaboration in clinical trials, legal aspects, and financial aspects, as well as digital management systems, to continuously cultivate medical, biostatistics, and management professionals in Taiwan with global competitiveness. It aims to achieve various innovative research and management methods through practical operations by clinical trial teams and the Center's professional management team. This includes promoting decentralized clinical trials and the application of digital health technologies to strengthen clinical trial collaboration, provide energy for domestic and international pharmaceutical clinical trials, accelerate drug market entry, and promote public health and welfare as part of the 2024-2027 plan. Taiwan Clinical Trial Consortium for Gastrointestinal Disease and Helicobacter keywords：Clinical trials, gastrointestinal diseases, Helicobacter pylori, gut microbiota, gastric cancer screening and prevention. Background and objectives: The formation of the Taiwan Gastrointestinal Clinical Trials Alliance, comprised of clinical physicians from ten major medical centers and hospitals in Taiwan, aims to enhance the efficiency and quality of clinical trial enrollment. The primary goals are to facilitate the validation of biopharmaceutical products for safety and efficacy in the domestic market, attract international pharmaceutical companies to conduct clinical trials in Taiwan, and encourage local healthcare professionals to initiate crucial clinical trials that can influence healthcare policy. Materials and methods: The alliance integrates clinical physicians, research teams with a foundation in biomedical science, and experts in bioinformatics and statistics to improve trial enrollment efficiency and quality. Research fields encompass (1) diagnosis and treatment of Helicobacter pylori, including detection of antibiotics-resistant strains, novel drugs or treatment methods, and long-term effects of H. pylori treatment; (2) development of novel drugs or treatment methods for gastrointestinal diseases; (3) diagnosis and treatment of gastrointestinal cancers, including new biomarkers and the development of novel treatment drugs or methods; (4) related research or treatment for other gastrointestinal diseases; (5) medical devices and image-assisted diagnostics or treatments. Expected Outcomes: Anticipated outcomes include: 1. Assisting the validation of the safety and efficacy of biopharmaceutical products for the domestic biotech and pharmaceutical industry, facilitating international market entry; 2. Attracting international pharmaceutical companies to conduct clinical trials in Taiwan, benefiting patients and accumulating experience among domestic healthcare institutions and professionals in conducting large-scale clinical trials; 3. Encouraging local healthcare professionals to initiate novel therapies or clinical trials that can influence healthcare policy. Expected Impact: 1. Policy Support: Provides localized evidence on H. pylori resistance and prevalence to establish and update Taiwan’s clinical screening and treatment guidelines. 2. Industry Expansion: Leverages clinical trials with domestic partners to promote Taiwan-developed medical products globally, enhancing international brand recognition. 3. Academic Influence: Elevates Taiwan’s global standing through multi-center trials and high-impact publications in prestigious international journals and conferences. Economic Impact: 1. Our research and development outcomes can serve as the basis for the development of new diagnostic reagents or therapeutic drugs; 2. Assisting in the internationalization of the domestic biotechnology industry: the alliance will continue to assist multiple domestic biotech companies in drafting and conducting clinical trials. Social Impact: 1. Screening and treating Helicobacter pylori (especially in high-risk groups for gastric cancer) can reduce the incidence and mortality rate of gastric cancer among the Taiwanese population, enhancing public health and societal competitiveness. 2. Strengthening academic value through clinical trials, elevating Taiwan's standing in international academic fields related to healthcare. 3. Assisting in the development and improvement of new drugs and the application of new medical technologies, instruments, and medical devices in clinical practice. Taiwan Breast Cancer Consortium keywords：Breast Cancer, clinical trial Breast cancer is the most common cancer in Taiwan. Its incidence is still increasing and mortality has not decreased. We successfully established Taiwan Breast Cancer Consortium (TBCC) as an academic research organization. We are able to initiate, conduct and monitor clinical trial. Many international pharmaceutical companies have involved TBCC for their breast cancer trials. TBCC also help domestic company to conduct their clinical trials. These trials lead to approval of new drugs. Hopefully, these advancement can help to decrease breast cancer mortality in Taiwan. Many international study groups, such as New Zealand and Australia Breast Cnacer Trials, have invited TBCC to collaborate with them to initiate clinical trials. TBCC also assists members in designing and implementing investigator-initiated trials. The members from TBCC have been invited to serve as steering committee members or chairpersons of various international trials and to be authors in many high-impact journals. Taiwan Clinical Trial Consortium for Liver Diseases Keywords：Hepatitis, hepatocellular carcinoma, trial, consortium Chronic viral hepatitis B and C and the related liver diseases (liver cirrhosis and HCC) are still major health problems in Taiwan. Furthermore, nonalcoholic fatty liver diseases and drug-induced liver injury will become the next most common etiology of liver diseases in Taiwan. Thus, multicenter trials supported by local or international bio-pharmaceutical companies as well as investigator-initiated clinical studies/trials (IITs) are needed. Problems in conduction of clinical trials or translational researches are encountered in the past few years. Besides, there are now many strong competitors in the Asia-Pacific region. Without cooperation, the recruitment of patients will be slow, and the competitive edge will be low. Thus, we have established a research network for liver diseases in Taiwan to help incorporating and facilitating the related research and development activities in the past decade, named “Taiwan Clinical Trial Consortium for Liver Diseases” (abbreviated as Taiwan Liver Diseases Consortium [TLC]). In the past years, we maintain the liver consortium for conduction of clinical trials and develop the platform for collection of clinical information for future translational research. We develop the steering committee for review and monitoring of all multicenter clinical trials or clinical studies covered by the TLC. We have recruited capable research assistants distributed in active study sites for the preparation and conduction of all clinical trials-related activities and jobs. After the development of the consortium, several important objectives have been achieved, including promotion of Taiwan liver research to be one of the world leaders, acceleration of the new drug or device developed by international or local Taiwan pharmaceuticals for liver diseases, and by investigator-initiated clinical trials. In the next 3 years, we will keep this momentum for promotion of the health of Taiwanese people through conduction of different kinds of clinical trials. Besides, we will adopt new strategy of so called full or hybrid decentralized clinical trials (DCTs), utilize new digital-based devices to help the conduction of clinical trials, and collect / analyze real world data (RWD) in order to derive real world evidence (RWE) complementing trial-based evidence and benefiting patients of clinical conditions not possible to conduct clinical trials. Finally, we will encourage and cultivate young generations for conduction of clinical trials. Taiwan Clinical Trial Consortium for Pediatric Infectious Diseases keywords：Taiwan Pediatric Infectious Diseases Alliance (TPIDA), platform, precision medicine, Clinical Trial Children bear the heaviest burden of infectious illness. An island-wide or even international multi-institution collaboration is especially needed to accomplish any clinical trial in the field of pediatric infectious diseases. This is the grounds that we established the first Taiwan Pediatric Infectious Diseases Alliance (TPIDA) in 2009. TPIDA, led by Professor Li-Min Huang of National Taiwan University Hospital, is a collaborative consortium of pediatric institutes in medical centers around the island. Since 2010, we together have already accomplished many joint researches regarding pediatric infectious diseases, and more studies about vaccine efficacy and effectiveness are on the way to establish Taiwan Pediatric Diseases Clinical Trial Consortium (TPDCTC). Now in TPIDA, we have about 20 core members, including infectious diseases specialists, virologists, molecular biologists, and more than 30 technicians and assistants working together. We had established a platform helpful for conducting clinical research activities in Taiwan. The database management platform is already established and is proved working after a long collaborative study of pediatric pneumonia. We build up the only respiratory tract virus bank in Taiwan. There are mainly two ways to detect viral pathogens from clinical respiratory tract samples: viral culture in animal/human cell lines, or PCR. However, there are two major disadvantages. Except for using conventional virus culture and PCR method, we will integrate the Human Airway Epithelium (HAE) system into the collection of respiratory virus bank. All clinical samples in which no known virus could be detected will be cultured in HAE system and stored. Any future translation research activities can utilize the clinical samples in the respiratory tract virus bank. Taiwan Clinical Trial Consortium for Pediatric Infectious Diseases steering meeting is held trimonthly, where updated data on various aspects are generated and discussed. Our aim is to expand this center from Taiwan Pediatric Infectious Diseases Alliance to an international collaboration. This large data bank and species bank will help this consortium to move to the new world of precision medicine. We will cooperate with the company to perform the clinical trial for the point of care molecular test. Taiwan Lung Cancer Clinical Trial Consortium keywords：Lung cancer, clinical trial, consortium, investigator-initiated trial, Asia-Pacific biomedical research and development industry center Lung cancer is the leading cause of cancer death worldwide. Due to ethnic differences, the causes and treatment strategies of lung cancer in Taiwan are significantly different from those in Europe and the United States. Therefore, attracting major international pharmaceutical and medical device manufacturers to conduct clinical trials in Taiwan, while strengthening domestically initiated clinical research and trials, is one of the important jobs related to the public health. The paradigm shift of lung cancer therapy from late-stage to early stage is a global trend. As the real-world data in NTUH, the 5-year overall survival of lung cancer has improved obviously from 22.1% in 2006-2011 to 54.9% in 2015-2020, along with a substantially diagnostic shift from advanced stage to early stage. With the benefit of National Health Insurance (NHI), the treatment of advanced lung cancer in Taiwan has clearly aligned with that in Europe and the United States. However, adjuvant therapy for early-stage lung cancer has yet to fully align with treatment guidelines in advanced international countries. Furthermore, accelerating the development and commercialization of Taiwan's biomedical and healthcare industries is a bottleneck for Taiwan to become a major biomedical R&D center in the Asia-Pacific region. To address these challenges, the Taiwan Lung Cancer Consortium (TALCC) will continue to assist domestic and international pharmaceutical and medical device manufacturers in conducting multicenter clinical trials, with a particular emphasis on supporting PI-initiated clinical trials. We aim to consolidate multi-centers from various regions across Taiwan, including core members such as National Taiwan University Hospital, Chung Shan Medical University Hospital, Tri-Service General Hospital, Taipei Veterans General Hospital, Linkou Chang Gung Memorial Hospital, Far Eastern Memorial Hospital and Shuang Ho Hospital. The establishment of this consortium will streamline the operation of multi-center clinical trials, including to foster the ability for adopting decentralized clinical trials (DCTs) and for collecting/ analyzing real world data (RWD) to real world evidence (RWE). Our ultimate goal is to expedite progress in lung cancer clinical trials and related research, ultimately enhancing the treatment and prognosis for lung cancer patients in Taiwan. Taiwan Clinical Trial Consortium for Adult Infectious Diseases keywords：Emerging infectious diseases, SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2）, antimicrobial agents, multidrug-resistant organisms, mycosis, influenza vaccines, adjuvanted vaccine, metagenomic next generation sequencing Background: While we have some achievement regarding infectious disease research in adult population in Taiwan, we are facing more challenges in recent decades. First, novel infectious agents emerge and spread globally more rapidly. Taiwan experienced SARS in 2003, pH1N1 in 2009, novel H7N9 in 2013, and COVID-19 for more than three years. Besides, antimicrobial multi-resistance in a wide range of human pathogens causing community infection or healthcare-associated infections is a global crisis for decades. Due to the diversity of etiology and resistant patterns, heterogeneity of patient population and acute disease occurring in critically ill or immunocompromised individuals, large scale, high-qualify clinical trials are limited. The research and development of new diagnostics or therapetuics are scare in recent decades, in part, due to difficulty in conducting clinical trials. Thus, it warrants multidisciplinary teams applying novel and feasible approaches to conduct clinical trials for infectious diseases efficiently. Thus, a highly efficient and coordinated clinical trial alliance is needed in order to respond promptly to combating emerging infectious diseases through developing diagnostic modalities, preventive vaccines, or novel therapeutic drugs. This alliance should be well prepared and integrated proactively through a series of training or conducting clinical trials for unmet medical needs we have faced in daily practice. To address these issues, we plan to reform the Taiwan Clinical Trial Consortium of Infectious Diseases (TCTCID), team up professionals from major medical centers and hospitals nationwide to optimize the efficiency and quality of clinical trials combating unmet medical needs regarding current endemic infectious diseases and upcoming emerging infectious diseases. Objectives: The project aims to integrate research resources, assist investigators to design and conducting state-of-the-art multicenter clinical trials and analyze real-world data to provide real-world evidence to support the developing or updating national or international guidelines; facilitate the domestic industries to develop and validate the efficacy and safety of diagnostic or pharmaceutical products, and increase visibility to attract international industries to conduct clinical trials in Taiwan. Methods: The Consortium will integrate infectious disease specialists, scientists for basic research, and experts for bioinformatics and statistics to optimize trial design, enrollment efficiency and research quality. The research scope will cover: diagnosis, vaccines and treatment of emerging infectious diseases, in line with national policies, such as novel influenza, COVID-19 and dengue; diagnostics and therapeutics for endemic infectious diseases due to multi-drug resistant bacteria and difficult-to-manage invasive fungal diseases; or medical devices to prevent infections. We will integrate more medical centers and other healthcare settings stepwise and nurture young researchers to enhance capacity and capability in conducting clinical trials in Taiwan. Anticipated Outcomes: Through these efforts, TCTCID provides a hub to facilitate the development of the domestic biotech and pharmaceutical industries by verifying the effectiveness and safety of products and enabling their entry into international markets. By attracting international pharmaceutical companies to conduct clinical trials in Taiwan, we will not only benefit patients but also accumulate experience in conducting large-scale clinical trials for domestic medical institutions and medical personnel, further promoting the development of the domestic biotech and pharmaceutical industry. Encourage domestic medical personnel to initiate clinical trials, propose solutions according to the needs of patients, improve patient prognoses, and promote the update and development of related medical policies. Through the implementation of the above plan, we expect to make significant contributions to the treatment and prevention of infectious diseases in Taiwan and globally. Taiwan Clinical Trial Consortium for Cardiovascular Disease keywords：cardiovascular diseases, clinical trial consortium, biomedical industry, digital health Despite advancements in medical care, cardiovascular diseases (CVDs) continue to be a leading cause of death globally, posing significant clinical, social, and economic challenges. In Taiwan, CVDs and stroke have consistently ranked as the second and third leading causes of death, draining substantial medical resources. The pressing need for enhanced diagnostic and therapeutic modalities has led to the active development of novel approaches to mitigate CV mortality and morbidity. A key to achieving these improvements is the initiation of multicenter trials conducted more efficiently via a clinical trial consortium. The TCTC-CVD initiative aims at fostering a collaborative ecosystem to accelerate cardiovascular research and clinical trials in Taiwan. Three core objectives underpin this initiative: 1. Facilitate the conduct of existing trials and attract international medical or pharmaceutical companies to initiate clinical trials in Taiwan by collaborating with Principle Investigators (PIs) engaged by Taiwan CROs, thereby nurturing a cadre of clinical trial professionals and leaders in Taiwan. 2. Assist domestic medical or pharmaceutical entities and medical material manufacturers in executing relevant clinical trials, researching, and developing new products to bolster the biotechnology sector in Taiwan. 3. Support investigator-initiated clinical trials focused on CVD diagnosis, prognosis, treatment, or equipment innovation, contributing to the growth of Taiwan's biotech industry and job creation. Methodology： 1. Integration and Decentralization of Clinical Trials: Leverage a decentralized Clinical Trial model which some or all trial activities take place at alternative locations including participants’ homes, local healthcare facilities, or nearby labs, reducing traditional site dependency and accelerating recruitment and data collection. 2. Digital Health Technology Utilization: Employ digital health technologies for real-time monitoring, data capture, and analytics to enhance trial efficiency, participant engagement, and data accuracy. 3. Interdepartmental and Multicenter Collaboration: (1) Establish 12 disease-specific branches within the 16 partnered medical centers, assigning PIs and Co-PIs based on their sub-specialties in CVDs. Each branch, led or co-led by a PI, will work autonomously yet collaboratively to manage clinical trials efficiently. (2) Foster collaboration among different branches and other scientific departments to expedite patient enrollment, share expertise, and reduce operational costs. Through experience sharing and collaboration between different hospitals and expertise, we could cultivate potential international PIs among young researchers in Taiwan. (3) Set up robust biospecimen banks with clarified disease phenotypes through these multicenter trials, creating a resourceful platform for further R&D in CVDs. (4) Assist investigator-initiated clinical trials and real-world data analsyis through TCTC-CVD collaboration platform to reach multicenter scale. 4. Engagement with External Entities: Collaborate with international and domestic medical, pharmaceutical companies, and other scientific departments to broaden the scope and impact of clinical trials conducted within Taiwan. Through these methodological pillars, the TCTC-CVD consortium aims to streamline and standardize the conduct of multicenter trials across various subtypes of CVDs, and proactively foster a conducive environment for continuous research, development, and innovation in cardiovascular care within Taiwan.

New Model of Excellence in Clinical Trial Program = 臨床試驗新型態卓越計畫

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