Clinical trials are an indispensable step in the process of drug development, especially when transforming traditional medicinal herbs into modern, scientifically recognized pharmaceuticals. This journey not only demands scientific rigor but also close collaboration between research institutions, healthcare organizations, and businesses. Let’s explore this complex yet meaningful process through the lens of the Clinical Trial Services at the Academy of Medical Sciences.

1. From Traditional Medicinal Herbs to Modern Medicine

Medicinal herbs have played a vital role in healthcare for thousands of years. In Vietnam, herbs such as ginseng, turmeric, notoginseng, and lingzhi mushroom have been widely used in traditional remedies. However, to transition these herbs into medications recognized by modern medicine, they must undergo a series of rigorous tests and trials.

The process begins with identifying the active ingredients in the herbs. This foundational step allows researchers to understand the biological effects and therapeutic potential of each compound. Promising compounds are then subjected to preclinical trials, where tests on cell models and animals are conducted to ensure basic safety and efficacy before progressing to clinical trials on humans.

2. What Are Clinical Trials?

Clinical trials are systematic studies conducted on humans to evaluate the safety, efficacy, and impact of new drugs or treatment methods. This process is typically divided into four main phases:

• Phase 1: Safety trials on a small group of healthy individuals (20–100 people) to determine safe dosage levels and potential side effects.
• Phase 2: Efficacy trials on a small group of patients (100–300 people) to assess the treatment's therapeutic potential.
• Phase 3: Large-scale trials on a broader patient population (1,000–3,000 people) to confirm safety and efficacy, often comparing the new treatment to existing options.
• Phase 4: Post-approval monitoring once the drug is licensed and on the market to identify rare side effects or other concerns.

At each phase, researchers must adhere strictly to ethical and legal regulations to ensure the safety and rights of participants.

3. The Role of the Clinical Trial Services at the Academy of Medical Sciences

The Academy of Medical Sciences is proud to be one of Vietnam’s leading centers offering internationally standardized clinical trial services. With a team of experienced experts and state-of-the-art infrastructure, the Academy has successfully supported numerous herb-based drug development projects domestically and internationally.

Key Services Provided

• Clinical Trial Design: The Academy offers comprehensive solutions, from drafting research plans and selecting evaluation criteria to managing data and analyzing results.
• Trial Management: Ensuring that clinical trials comply with the strict standards of the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA).
• Quality Assurance: The Academy employs independent monitoring and inspection systems to ensure the transparency and reliability of research outcomes.
• Legal Consultancy: Assisting businesses and researchers in completing regulatory documentation to obtain approval from health authorities.

4. A Success Story: From Research to Reality

One remarkable success story of the clinical trial services at the Academy of Medical Sciences is the development of a drug derived from the Phyllanthus amarus plant. This traditional herb, commonly used to treat liver-related illnesses, has been a staple in traditional medicine.

With the Academy’s support, researchers successfully isolated the primary active compound in Phyllanthus amarus and conducted comprehensive clinical trials. The results demonstrated that the drug was not only safe but also effective in improving liver function and reducing inflammation. Today, this product has been approved for market distribution, offering hope to millions of patients.

5. Challenges in the Clinical Trial Process

Despite its many benefits, clinical trials face significant challenges:

• High Costs: Clinical trials are costly, especially in later phases, as the number of participants increases.
• Lengthy Timelines: The process often takes 7–10 years or more, from initial trials to market approval.
• Legal and Ethical Risks: Ensuring the rights and safety of participants requires strict oversight by regulatory bodies.
• Bridging Traditional and Modern Medicine: Converting traditional remedies into modern pharmaceuticals can be difficult due to a lack of scientific evidence or standardized dosages.

6. The Future of Medicinal Herbs in Modern Medicine

Amid globalization and growing interest in natural medicine, medicinal herbs are gaining increasing attention. Vietnam, with its rich biodiversity of medicinal plants, has the potential to become a regional hub for developing herb-based pharmaceuticals.

The Academy of Medical Sciences has been actively contributing to elevating Vietnam’s medical standing on the global stage. Through investments in research and clinical trials, many traditional medicinal herbs will have the opportunity to be standardized and recognized in modern medicine, offering safe and effective treatment options for patients.

Conclusion

Clinical trials are a long and challenging journey, but they open doors to tremendous opportunities. With the support of organizations like the Academy of Medical Sciences, the transition from medicinal herbs to pharmaceuticals not only preserves traditional values but also drives Vietnam’s medical advancements. Looking forward, with sustained investment and collaboration, Vietnam’s medicinal herbs will continue to shine on the global market, delivering benefits not only in economic terms but also for the health and well-being of communities worldwide.