Dietary supplements (DS) play a significant role in supporting health and preventing diseases. However, to ensure safety and efficacy, DS must undergo a rigorous clinical trial process. Clinical trials not only verify the scientific validity of the product but also provide a legal foundation for market authorization. In Vietnam, the Academy of Medical Sciences is central to researching, supervising, and implementing these clinical trial procedures.

This article provides a detailed overview of the clinical trial process for DS, from designing the study to evaluating and publishing results, offering readers a clearer understanding of its importance and practical implementation steps.

I. Definition and Role of Clinical Trials

1. What are clinical trials?

Clinical trials are systematic studies designed to evaluate the safety and efficacy of a medical product, including DS, on humans. They are a mandatory step to transition a product from the laboratory to the market.

2. The role of clinical trials for DS

• Ensuring safety: Early identification of unwanted side effects.
• Validating efficacy: Proving the product delivers its claimed health benefits.
• Supporting regulation and approval: Providing a scientific basis for regulatory authorities to grant market authorization.
• Building trust: Enhancing consumer confidence in the product's quality and efficacy.

II. Phases of Clinical Trials

The clinical trial process for DS is divided into four main phases:

1. Preclinical phase

• Objective: Preliminary assessment of product safety and potential efficacy through laboratory and animal studies.
• Main activities:
• Outcome: Determination of optimal dosage and baseline data for human trials.

2. Phase 1: Clinical trials on a small group of volunteers

• Objective: Assessing the safety of the product when used by humans.
• Characteristics:
• Outcome: Basic safety data.

3. Phase 2: Trials on a smaller user group

• Objective: Initial evaluation of product efficacy.
• Characteristics:
• Outcome: Evidence of the product's health benefits.

4. Phase 3: Trials on a larger user group

• Objective: Demonstrating efficacy on a larger scale and comparing results with a control group.
• Characteristics:
• Outcome: Comprehensive data for regulatory approval.

5. Phase 4: Post-market surveillance

• Objective: Monitoring safety and efficacy under real-world usage conditions.
• Characteristics:
• Outcome: Ensuring the product maintains quality and efficacy on the market.

III. Clinical Trial Process for DS

1. Study design

The study design is the first and most critical step to ensure the scientific rigor and effectiveness of clinical trials.

• Defining objectives:
• Selecting research methods:
• Recruiting volunteers:

2. Trial implementation

• Preparation:
• Execution:

3. Data collection and analysis

• Data recording:
• Analysis:

4. Reporting and publishing results

• Report writing:
• Publication:

IV. Role of the Academy of Medical Sciences

1. Ensuring scientific integrity and objectivity

The Academy of Medical Sciences conducts independent research free from manufacturer influence, providing reliable and objective data.

2. Offering high-quality infrastructure and expertise

With modern laboratories and top-tier experts, the academy ensures that trials comply with international standards.

3. Supporting legal and regulatory approvals

The academy acts as a bridge between DS manufacturers and regulatory bodies, aiding in the completion of legal documentation for market authorization.

4. Promoting international collaboration

The academy collaborates with global research organizations to improve clinical trial quality and advance Vietnam’s integration into global healthcare systems.

V. Challenges in Clinical Trials

1. High costs: Clinical trials require substantial financial resources, particularly for long-term studies.
2. Lengthy process: Trials often span months to years, delaying market entry.
3. Data management: Ensuring accuracy and transparency in data collection and analysis is a significant challenge.
4. Volunteer recruitment: Identifying and retaining suitable volunteers can be difficult.

VI. Conclusion

Clinical trials are a complex but indispensable process for ensuring the safety and efficacy of dietary supplements. With the support of the Academy of Medical Sciences, these trials are conducted scientifically, objectively, and in compliance with international standards.

In the future, to further enhance the quality of DS in Vietnam, greater investment in research, strengthened international collaboration, and increased public awareness of the role of clinical trials are necessary. The Academy of Medical Sciences will continue to lead this mission, contributing to the development of a modern and sustainable Vietnamese healthcare system.