As part of the strategic roadmap to enhance postgraduate education quality and integrate international standards into biomedical research, the Faculty of Pharmacy at Pham Ngoc Thach University of Medicine has officially launched the advanced module "Clinical Trial Design and Analysis." This initiative represents a pivotal step in standardizing the clinical research capabilities of high-level pharmaceutical human resources for the 2025–2026 academic year.
1. General Overview and Educational Context
The module is specifically designed for 27 students enrolled in the Master of Pharmacology and Clinical Pharmacy program, Cohort 2024–2026. The intensive training period is scheduled from January 9, 2026, to January 31, 2026.
The integration of clinical trial methodology into the Master’s curriculum not only addresses the critical shortage of experts in drug development and research but also directly aligns with the Ministry of Health’s directives to strengthen clinical pharmacy capacity and medical quality management in the modern era.
2. Curriculum Content: A Multidimensional and In-depth Approach
The curriculum is structured through a harmonious blend of foundational theory and rigorous international standards, covering the entire lifecycle of a clinical trial:
- Methodology and Research Design: Students are introduced to various Clinical Trial Designs, ranging from Early Phase Trials to specialized areas such as Paediatric Clinical Trials. This provides the core framework for developing scientific reasoning in protocol construction.
- Management and Operational Excellence: The module delves into Trial Management, Data Management, and Statistical Analysis. A particular emphasis is placed on compliance through Good Clinical Practice (GCP) standards and Regulatory Affairs.
- Safety and Ethics: In biomedical research, Ethics Issues and Pharmacovigilance are inseparable pillars. The curriculum equips students to safeguard the rights and safety of research subjects while maintaining strict control over study medications and Medical Devices.
- Leadership and Integration Skills: A distinguishing feature of this module is the integration of Leadership for Principal Investigators (PIs) and Scientific Communication (Open Research and Scientific Publishing). This ensures that graduates possess both technical expertise and the ability to lead multi-center research projects and achieve international publication.
3. Strategic Value and Future Outlook
The introduction of the "Clinical Trial Design and Analysis" module at Pham Ngoc Thach University of Medicine reflects the institution's vision of building a sustainable pharmaceutical research ecosystem. By equipping students with advanced quality management and data analysis skills, the program reinforces the University's position in training clinical pharmacists capable of executing international-standard research within Vietnam.
Furthermore, this module serves as a bridge, aligning students with the regulatory standards of global health organizations, thereby enhancing the credibility and value of domestically conducted clinical trials.
4. Conclusion
In summary, the implementation of this module for the 2024–2026 Master’s cohort is a significant achievement in modern medical and pharmaceutical education. Through its comprehensive content and practical approach, the module not only imparts essential knowledge but also fosters scientific integrity and leadership. The ultimate objective remains the optimization of therapeutic efficacy and the assurance of patient safety through robust clinical evidence.
