Modern medicine continuously advances through new discoveries in research and experimentation. Medical research helps experts better understand diseases, their underlying mechanisms, and factors affecting health. In this context, two prominent concepts are "clinical research" and "clinical trials," which play crucial roles in determining the efficacy and safety of treatments, from medications to surgical methods or other medical interventions.

The Academy of Medical Sciences, as a research and development organization in the field of health, has been actively promoting these studies. Not only does it support researchers in conducting feasible and safe projects, but it also guides research that meets public health needs, ensuring the applicability and effectiveness of research outcomes.

2. The Concept of Clinical Research

2.1 Definition of Clinical Research

Clinical research involves studies conducted on humans to gather data on health conditions, diseases, and related factors. Clinical research can encompass a variety of study types, such as descriptive studies, analytical studies, and interventional studies.

Clinical research does not necessarily involve direct treatment or intervention; rather, it may focus solely on data collection, analyzing relationships between factors, or identifying potential risks within a community.

2.2 Objectives of Clinical Research

The main objective of clinical research is to enhance understanding of diseases, thereby proposing preventive and therapeutic solutions. Key goals may include:

• Identifying trends and disease distribution across various population groups.
• Detecting risk factors that may contribute to the development of specific diseases.
• Assessing the effectiveness of interventions, not only in treatment but also in disease prevention.
• Analyzing causal relationships among environmental, behavioral, genetic factors, and health status.

2.3 Types of Clinical Research

Clinical research is classified into several types based on research objectives and methods, which may include:

• Descriptive research: Studies aimed at describing the current state or trends of diseases in a community. For example, studies on disease incidence or mortality rates due to a specific disease, or research on the clinical characteristics of newly emerging diseases.
• Analytical research: Focuses on analyzing relationships between risk factors and diseases. For instance, analyzing the impact of smoking on lung cancer risk.
• Interventional research: Though overlapping with clinical trials to some extent, interventional research primarily evaluates the impact of treatment or preventive interventions.

3. The Concept of Clinical Trials

3.1 Definition of Clinical Trials

A clinical trial is a specific type of clinical research in which researchers directly intervene in subjects to evaluate the effectiveness and safety of new treatments, medications, or medical devices. For a new treatment to be accepted and widely applied, it must undergo a rigorous multi-stage clinical trial process, from safety assessment to large-scale efficacy testing.

3.2 Stages of Clinical Trials

Clinical trials are typically divided into four stages, including:

• Phase I: This is the initial trial phase, where the new treatment is tested on a small number of people (usually 20-80 individuals) to assess safety and determine the appropriate dosage.
• Phase II: The new treatment is tested on a larger group (a few hundred people) to evaluate efficacy and continue monitoring safety.
• Phase III: Large-scale trials (thousands of people) assess efficacy and safety in real-world settings. This phase often compares the new treatment with existing methods.
• Phase IV: This is the post-approval monitoring phase, where researchers continue to observe efficacy and rare side effects within the community.

3.3 The Role of Clinical Trials

Clinical trials ensure that new treatments are safe and effective before being widely implemented. This trial process not only protects patients' health but also builds confidence in modern medical advancements. Clinical trials serve as a strict screening system, helping to eliminate ineffective or high-risk treatments.

4. Key Differences Between Clinical Research and Clinical Trials

4.1 Differences in Purpose

The purpose of clinical research is to collect and analyze information about diseases, risk factors, and public health status. In contrast, clinical trials focus on testing and determining the safety and efficacy of new treatments.

4.2 Differences in Research Design

Clinical research typically includes various types of studies, such as observational, descriptive, and analytical, which may not require direct intervention. In contrast, clinical trials demand a rigorous research design, with controlled intervention and comparison groups.

4.3 Differences in Research Subjects

In clinical research, subjects can include the broader community or specific population groups. Meanwhile, clinical trial subjects are usually volunteers meeting strict criteria to minimize confounding factors and ensure consistency in results.

4.4 Differences in Data Analysis and Evaluation

Clinical research may use statistical methods to identify trends or relationships among factors. In clinical trials, results are evaluated specifically through trial phases and must adhere to strict safety and efficacy standards.

5. Role of the Academy of Medical Sciences in Clinical Research and Clinical Trials

5.1 Supporting Clinical Research

The Academy of Medical Sciences plays an important role in guiding and supporting clinical research in Vietnam. The Academy provides training programs and necessary documentation to ensure that researchers adhere to standardized procedures and ethics in research.

5.2 Managing Clinical Trials

In the clinical trial process, the Academy of Medical Sciences ensures that trial procedures comply with international standards. The Academy issues licenses and supervises trials to protect participants' rights and safety.

5.3 Contributions to the Healthcare Community

Through support for research and trials, the Academy of Medical Sciences contributes to the development of the national healthcare system, helping to improve the quality of healthcare for the community.

6. Conclusion

Both clinical research and clinical trials play essential roles in modern medicine, aiming to enhance the understanding of diseases and improve treatment methods. The Academy of Medical Sciences has contributed significantly to these processes, guiding and managing research and trials to protect public health and advance medicine in Vietnam.