Clinical trials

Clinical trials are a critical pillar of pharmaceutical research at the Academy of Medical Sciences, Vietnam (AMS Vietnam). They represent the final and most decisive stage in the development of pharmaceutical products, where safety, efficacy, and clinical value are rigorously evaluated in human subjects. Through well-designed and ethically governed clinical trials, AMS Vietnam contributes to the generation of high-quality evidence that supports regulatory approval, clinical adoption, and public trust in pharmaceutical innovations.

The Academy conducts and coordinates clinical trials in accordance with national regulations and internationally recognized standards, ensuring that all research outcomes are scientifically robust, ethically sound, and clinically meaningful.

Clinical trials serve as the bridge between preclinical research and real-world medical use. After a pharmaceutical product has demonstrated acceptable safety and biological activity in laboratory and preclinical animal studies, clinical trials assess its performance in humans under controlled conditions.

At AMS Vietnam, clinical trials aim to:

• Evaluate the safety profile of pharmaceutical products
• Determine therapeutic efficacy and optimal dosing
• Identify potential adverse effects and contraindications
• Compare new interventions with existing standards of care
• Generate evidence to support regulatory submission and clinical guidelines

These objectives ensure that pharmaceutical products introduced into healthcare systems are both effective and safe for patients.

The Academy of Medical Sciences, Vietnam conducts and supports clinical trials across a broad range of pharmaceutical domains, including:

• Small-molecule drugs
• Biologically derived products
• Herbal and plant-based pharmaceuticals
• Novel formulations and delivery systems
• Repurposed medicines for new indications

Clinical trials may be investigator-initiated, sponsor-driven, or conducted in collaboration with domestic and international partners, including pharmaceutical companies, hospitals, and academic institutions.

AMS Vietnam supports clinical trials across all major phases of pharmaceutical development, with clear scientific objectives at each stage.

Phase I: Safety and Tolerability

Phase I trials focus on evaluating the safety, tolerability, and pharmacokinetics of a pharmaceutical product in a small group of healthy volunteers or patients. These studies assess how the drug is absorbed, distributed, metabolized, and eliminated, and help establish safe dosage ranges.

At AMS Vietnam, Phase I trials are conducted under strict clinical monitoring with comprehensive risk management protocols.

Phase II: Efficacy and Dose Optimization

Phase II trials evaluate preliminary efficacy in patients with the target condition while continuing to assess safety. These studies help determine optimal dosing regimens and refine clinical endpoints.

The Academy emphasizes rigorous study design and statistical methodology to ensure reliable and interpretable results at this stage.

Phase III: Confirmatory Clinical Evaluation

Phase III trials are large-scale studies designed to confirm efficacy, monitor adverse reactions, and compare the investigational product with standard treatments or placebo. Results from Phase III trials form the primary evidence base for regulatory approval.

AMS Vietnam collaborates closely with clinical sites and regulatory stakeholders to ensure data quality, protocol compliance, and patient safety throughout these trials.

Phase IV: Post-Marketing Studies

Post-marketing (Phase IV) studies assess long-term safety, effectiveness, and real-world performance after a pharmaceutical product has been approved and introduced into clinical practice. These studies support pharmacovigilance and continuous benefit–risk assessment.

Ethical integrity is fundamental to all clinical trials conducted under the auspices of the Academy of Medical Sciences, Vietnam. Every clinical trial undergoes rigorous review and approval by an independent ethics committee or institutional review board (IRB).

Key ethical principles upheld include:

• Respect for persons and informed consent
• Protection of participant safety and confidentiality
• Scientific validity and social value of research
• Transparency, accountability, and regulatory compliance

Clinical trials are conducted in alignment with Good Clinical Practice (GCP), national pharmaceutical regulations, and relevant international guidelines.

AMS Vietnam applies advanced methodological standards to ensure the scientific credibility of clinical trials. This includes:

• Robust protocol development with clearly defined endpoints
• Appropriate randomization and blinding strategies
• Valid statistical analysis plans
• Data quality assurance and monitoring
• Risk-based trial management

Study designs are tailored to the specific characteristics of each pharmaceutical product, therapeutic area, and target population.

The Academy of Medical Sciences, Vietnam maintains a strong clinical research infrastructure that supports high-quality trial execution. This includes:

• Partnerships with accredited hospitals and clinical research centers
• Trained investigators and clinical research staff
• Data management and clinical monitoring systems
• Pharmacovigilance and adverse event reporting mechanisms

This infrastructure enables the Academy to conduct trials efficiently while maintaining the highest standards of participant safety and data integrity.

AMS Vietnam places participants at the center of clinical research. Recruitment, enrollment, and follow-up processes are designed to be transparent, respectful, and culturally appropriate.

Participants receive clear information about study objectives, procedures, potential risks, and benefits. Informed consent is obtained in accordance with ethical and legal requirements, and participants retain the right to withdraw from a study at any time without consequence.

Clinical trials at AMS Vietnam are often conducted in collaboration with:

• Pharmaceutical and biotechnology companies
• Academic and research institutions
• Healthcare providers and hospital networks
• International research organizations

These partnerships enable resource sharing, capacity building, and alignment with global research priorities while maintaining the Academy’s independence and scientific integrity.

High-quality data is the foundation of credible clinical research. AMS Vietnam ensures accurate data collection, secure data storage, and appropriate statistical analysis.

Findings from clinical trials contribute to:

• Regulatory submissions and product registration
• Peer-reviewed scientific publications
• Clinical practice guidelines
• Policy and health system decision-making

Where appropriate, results are disseminated to the scientific community and relevant stakeholders to maximize research impact.

Through its clinical trial activities, the Academy of Medical Sciences, Vietnam supports innovation in pharmaceutical development while safeguarding public health. Clinical trials enable the introduction of new therapies, improve existing treatments, and expand therapeutic options for patients.

By combining scientific rigor, ethical responsibility, and clinical relevance, AMS Vietnam plays a vital role in advancing pharmaceutical research and strengthening the evidence base for modern medicine.

Clinical trials conducted under the leadership of the Academy of Medical Sciences, Vietnam reflect a commitment to excellence, transparency, and societal benefit. Through continuous improvement, international collaboration, and adherence to the highest standards, AMS Vietnam ensures that pharmaceutical clinical research contributes meaningfully to better health outcomes in Vietnam and beyond.