TNLS Introduce

WHAT ARE CLINICAL TRIALS?

Clinical trials are essential scientific studies in the development of new drugs, vaccines, therapies, biologics, and medical devices, aimed at evaluating their safety and clinical efficacy before widespread use. They are a mandatory step in the product approval process by regulatory authorities. According to the Good Clinical Practice (GCP) guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP E6(R3), 2025), a clinical trial is defined as:

“Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s); and/or to identify any adverse reactions to an investigational product(s); and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.”

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PHASES OF CLINICAL TRIALS

Clinical trials consist of a series of stages, known as phases. Each phase is designed to answer specific questions and progressively build understanding of a new treatment before it is approved or recommended for use.

Phase I – Initial Safety Assessment
Phase I – Initial Safety Assessment
Participants: A small group of healthy volunteers (20–100 individuals). Objective: To determine the safe dosage range, assess pharmacokinetics and pharmacodynamics, and identify early side effects.
Phase II – Preliminary Efficacy Evaluation
Phase II – Preliminary Efficacy Evaluation
Participants: Patients who have the target condition (several hundred individuals). Objective: To evaluate treatment effectiveness, compare with placebo or standard therapy, and continue collecting safety data.
Phase III – Confirmatory Efficacy and Safety
Phase III – Confirmatory Efficacy and Safety
Participants: A large group of patients (hundreds to thousands). Objective: To confirm the benefit–risk profile and provide robust evidence for regulatory approval.
Phase IV – Post-Marketing Surveillance
Phase IV – Post-Marketing Surveillance
Participants: Broad patient populations in real-world settings. Objective: To monitor long-term effectiveness, detect rare adverse effects, and explore expanded indications.

IMPORTANCE OF CLINICAL TRIALS AND CONTRIBUTION TO SCIENCE AND HEALTHCARE

Clinical trials are the only scientific method that provides empirical evidence in humans, serving as the foundation of Evidence-Based Medicine.

GENERATING KNOWLEDGE AND ADVANCING ACADEMIC EXELLENCE

Clinical trials serve as the critical bridge that translates scientific discoveries from the laboratory into meaningful clinical evidence, forming the foundation of evidence-based medicine.

  • Reliable evidence: Clinical trials provide high-quality scientific data to inform clinical practice guidelines, establish causal relationships between interventions and treatment outcomes, and ultimately improve the effectiveness of healthcare delivery.
  • Optimizing treatment strategies: Clinical trials help determine appropriate dosing, understand mechanisms of action, and anticipate potential adverse effects—thereby enabling more effective and tailored treatment options.
  • Driving academic innovation: Findings from clinical trials pave the way for new therapies while strengthening research capacity and enhancing the academic reputation and global standing of research institutions.
GENERATING KNOWLEDGE AND ADVANCING ACADEMIC EXELLENCE

CONTRIBUTING TO HEATHCARE SYSTEMS AND COMMUNITIES

Beyond their role in generating knowledge, clinical trials directly enhance the quality of healthcare systems and community health, while opening new opportunities for diseases that currently lack effective treatments.

  • Ensuring participant safety: Clinical trials are conducted in accordance with international ethical and regulatory standards and are approved by the Ministry of Health, ensuring maximum protection of participants’ rights and safety.
  • Foundation for regulatory approval and health policy: Data from clinical trials serve as the basis for regulatory decisions by authorities such as the Ministry of Health, the U.S. FDA, and the European Medicines Agency (EMA).
  • Standardizing clinical practice: Clinical trials contribute to refining and updating treatment protocols, ensuring that only proven, effective interventions are widely adopted.
  • Driving innovation and global integration: Clinical trials foster international collaboration, support the development of high-quality human resources, and strengthen research capacity—thereby enhancing Vietnam’s academic standing in the global medical landscape.
CONTRIBUTING TO HEATHCARE SYSTEMS AND COMMUNITIES

CRITERIA/BENEFITS OF PARTICIPATING IN CLINICAL TRIALS

Participating in a clinical trial is a voluntary decision that offers meaningful benefits- not only for patients, but also for the broader scientific and healthcare community.

Access to Innovative Treatments
Access to Innovative Treatments
Participants may gain access to advanced therapies currently under investigation, which can be particularly valuable when standard treatments are not effective.
Close Medical Monitoring and Care
Close Medical Monitoring and Care
Throughout the study, participants receive close health monitoring and care under rigorous protocols, enabling early detection and timely management of any medical issues.
Protection of Rights and Safety
Protection of Rights and Safety
Participants are fully informed before signing the Informed Consent form, retain the right to withdraw at any time, and are protected in terms of rights and personal data privacy in accordance with Vietnamese and international regulations.
Support for Study-Related Costs
Support for Study-Related Costs
Depending on the study, participants may receive support for costs related to their participation throughout the trial.
Contribution to Medical Knowledge
Contribution to Medical Knowledge
Participation not only provides individual benefits but also contributes to the development of new treatments, helping to improve the quality of healthcare for the community in the future.

FAQs

Yes. Clinical trials at Vinmec – VinUni are conducted in accordance with international Good Clinical Practice (ICH-GCP) standards and comply with Ministry of Health regulations. Each study must be approved by an Ethics Committee before initiation. Throughout the study, participants are closely monitored by a team of physicians and healthcare professionals to ensure their safety and rights are fully protected.

Each clinical trial has specific inclusion and exclusion criteria depending on its objectives (e.g., age, health status, or specific medical conditions). Individuals who meet these criteria may be invited to participate after receiving full information about the study and providing voluntary consent.

In most clinical trials, study-related costs – such as investigational products, certain tests, or study visits – may be covered by the study sponsor. Participants will be clearly informed about benefits, potential costs (if any), and available support before deciding to participate.

If you are interested in participating in a clinical trial, you can contact the VinUni – Vinmec Clinical Trials Unit (CTU) or consult with physicians within the Vinmec Healthcare System for information on ongoing studies and guidance on the next steps.