In the field of healthcare, dietary supplements (DS) have gained significant attention due to their potential to support health and prevent disease. However, to ensure these products are truly safe and effective, clinical trials are essential. Clinical trials not only verify the effects of DS but also ensure consumer safety, while building trust and credibility for manufacturers in the market. In this article, we will explore the stages in the clinical trial process, specifically as applied at the Institute of Medical Sciences.

2. What Are Clinical Trials?

Clinical trials are systematic scientific research processes in which products, such as DS, are tested on humans to evaluate their safety and effectiveness. Clinical trials generally consist of multiple stages, each with specific objectives to ensure the product meets safety and efficacy standards before being marketed. This process is particularly important given the increasing number of DS that are developed without adequate scientific evidence to support the advertised benefits.

3. Why Are Clinical Trials Necessary?

3.1. Ensuring Consumer Safety

Safety is the top priority when using health-related products. Clinical trials help identify potential side effects and ensure that products do not harm users, especially individuals with specific health conditions or who are taking other medications.

3.2. Verifying Actual Effectiveness

Clinical trials help verify the real benefits of the product, confirming that the advertised effects of DS have a scientific basis and provide tangible health benefits for users.

3.3. Building Consumer Trust

Consumers are more likely to trust products that have undergone clinical trials, as they know the product has been rigorously tested for safety and effectiveness. This also helps manufacturers establish trust and credibility for their products in the market.

3.4. Promoting Sustainable Growth of the DS Industry

Clinical trials help the DS industry grow sustainably, as products are developed based on scientific evidence and meet safety and effectiveness requirements. This approach not only protects consumer rights but also contributes to a healthy, reliable industry.

4. When Do Dietary Supplements Need to Undergo Clinical Trials?

Not all DS require clinical trials before being marketed; however, in some cases, clinical trials are necessary, including:

• New Products: Products with new ingredients or benefits that have not been previously researched.
• Disease-Support Products: Products that claim to help prevent or treat specific conditions need clinical trials to ensure effectiveness and safety.
• Products for Sensitive Groups: Products intended for the elderly, children, pregnant women, or people with pre-existing conditions require rigorous testing to avoid harming these groups.
• Products with Complex Mechanisms of Action: Products with mechanisms that may profoundly impact health should undergo clinical trials.

5. The Clinical Trial Process for Dietary Supplements at the Institute of Medical Sciences

The Institute of Medical Sciences is one of the leading institutions in Vietnam for research and clinical trials. The clinical trial process at the Institute includes the following main stages:

5.1. Stage 1: Initial Safety Testing

In this stage, the product is tested on a small group of healthy participants to evaluate preliminary safety and identify potential side effects. This step is crucial to determine whether the product is safe enough to proceed to subsequent stages.

5.2. Stage 2: Initial Efficacy Testing

This stage focuses on assessing the initial effectiveness of DS on a target group of participants. Researchers evaluate whether the product delivers the desired effects and determine the safe and effective dosage for different groups.

5.3. Stage 3: Large-Scale Effectiveness Testing

This is the primary testing stage, involving a large group of participants, to confirm the product’s effectiveness in real-world conditions. The product may be compared with standard treatments or placebos to ensure it genuinely delivers the advertised benefits.

5.4. Stage 4: Post-Market Surveillance

After the product has been released, this stage involves tracking and recording rare side effects or issues that may arise in actual use. This stage also collects long-term data to assess the product's effectiveness over time.

6. Conclusion

Clinical trials are crucial to ensure that DS are safe and effective before they reach consumers. At the Institute of Medical Sciences, clinical trials are conducted according to high scientific and ethical standards, ensuring that products not only benefit users but also comply with strict safety requirements. Through clinical trials, DS are not only enhanced in quality but also contribute to building trust and credibility in the market.

In the context of a rapidly growing DS industry, conducting clinical trials is a necessary and responsible step to protect consumers and support sustainable development in this industry.