Functional foods (FFs) are increasingly playing a crucial role in improving public health. However, to ensure safety and efficacy, all FF products must undergo a rigorous clinical trial process. This article provides a detailed overview of the 5 main steps in clinical trials for FFs, helping professionals and businesses understand the current requirements and standards.

1. Designing the Clinical Study

1.1. Defining Research Objectives

The goal of clinical trials is to evaluate the safety and effectiveness of FF products. Before beginning, researchers need to determine:

• What biological effects does the product have?
• Who is the target audience (e.g., elderly individuals, children, or people with chronic conditions)?

1.2. Establishing Study Design

Common designs include:

• Randomized Controlled Trials (RCTs): Considered the "gold standard" in clinical research.
• Non-Controlled Studies: Suitable for cases where conducting RCTs is difficult.

Researchers must also ensure randomization, appropriate sample size, and the use of blinding methods (single-blind or double-blind) to minimize bias.

2. Ethical Approval

2.1. Establishing an Ethics Committee

Before any trial begins, the project must be approved by an independent Ethics Committee. The committee reviews:

• The rights and safety of participants.
• Potential risks associated with the FF product.

2.2. Protecting Participant Rights

Participants must be fully informed about:

• The purpose of the research.
• Possible risks and benefits.
• Their right to withdraw at any time without penalty.

3. Conducting the Clinical Trial

3.1. Phase 1: Small-Scale Testing

• Objective: Assess preliminary safety and determine appropriate dosage.
• Sample Size: 10-30 healthy individuals.

3.2. Phase 2: Initial Efficacy Assessment

• Objective: Verify biological effects and detect any side effects.
• Sample Size: 50-100 individuals resembling the target audience.

3.3. Phase 3: Large-Scale Testing

• Objective: Evaluate the product's true effectiveness and confirm its safety.
• Sample Size: Hundreds to thousands of participants.
• Outcome: Data from this phase is used for product registration with regulatory authorities.

3.4. Phase 4: Post-Market Surveillance

• Objective: Monitor efficacy and detect rare side effects after the product is introduced to the market.

4. Data Analysis and Reporting

4.1. Data Analysis

Data collected during the trial must be thoroughly analyzed to draw accurate conclusions. Key steps include:

• Ensuring data completeness.
• Handling discrepancies or missing data.
• Statistical analysis: Using specialized software such as SPSS, R, or SAS to identify significant differences between the treatment and control groups.

4.2. Drafting the Report

The clinical trial report must be detailed, clear, and adhere to international guidelines (e.g., CONSORT). A typical report includes:

• Introduction and study objectives.
• Methods.
• Results and analysis.
• Discussion and conclusions.

5. Registration and Publication

5.1. Registration with Regulatory Authorities

Upon completing the trial, data must be submitted to regulatory bodies such as the Ministry of Health or equivalent organizations for approval. The registration dossier usually includes:

• Clinical trial results.
• Evidence of product quality and safety.

5.2. Publishing Results

Publishing research findings in scientific journals or presenting them at international conferences not only enhances the product's credibility but also promotes transparency in research.

Conclusion

The clinical trial process for FFs involves a complex series of activities that require close collaboration among scientists, businesses, and regulatory agencies. The ACADEMY OF MEDICAL SCIENCES is committed to supporting stakeholders in conducting studies that adhere to international standards, ensuring public health and enhancing the reputation of Vietnamese products in the global market.

For additional consultation on clinical trial procedures or FF product registration, please contact the ACADEMY OF MEDICAL SCIENCES for assistance.