About Clinical Trials

Clinical trials play a critical role in addressing public health and population health challenges.

A clinical trial is a scientific study conducted in humans to evaluate the safety and effectiveness of new drugs, novel treatment strategies, or other health interventions. Before any intervention is tested in humans, it must undergo rigorous preclinical evaluation, including laboratory studies and animal models.

Each clinical trial follows a detailed research protocol that defines the intervention and comparison groups, randomization procedures to ensure objectivity, blinding methods to minimize bias, outcome measures, follow-up duration, and predefined primary and secondary endpoints.

Phases of Clinical Trials

Clinical trials are conducted through a series of stages, known as phases. Each phase is designed to answer specific research questions and to progressively build evidence on a new treatment before it is approved or recommended for clinical use.

Phase I
Initial Safety Assessment

Participants: A small group of healthy volunteers (typically 20–100 participants).

Objective: To assess safety, determine tolerated dosage ranges, evaluate pharmacokinetics and pharmacodynamics, and identify early adverse effects.

Phase II
Preliminary Efficacy Evaluation

Participants: Patients who have the target disease (usually several hundred participants).

Objective: To evaluate preliminary efficacy, compare the intervention with placebo or standard treatment, and continue safety monitoring.

Phase III
Confirmatory Efficacy and Safety

Participants: A large patient population (ranging from several hundred to several thousand participants).

Objective: To confirm therapeutic benefits, further assess safety, and establish the benefit–risk profile required for regulatory approval.

Phase IV
Post-Marketing Studies

Setting: Real-world clinical practice across diverse patient populations.

Objective: To monitor long-term effectiveness, identify rare or delayed adverse events, and explore additional indications after regulatory approval.

Scientific Value and Participant Rights in Clinical Trials

Access to Innovative <br> Treatment Approaches

Access to Innovative
Treatment Approaches

Participants may have the opportunity to access advanced therapies and treatment strategies that are under clinical investigation, particularly in cases where standard treatments have not achieved the desired outcomes.
Close Medical <br>Monitoring and Care

Close Medical
Monitoring and Care

Participants receive regular health monitoring and medical care in accordance with strict research protocols, enabling early detection and timely management of potential health issues.
Protection of Participant <br>Rights and Safety

Protection of Participant
Rights and Safety

All clinical trials are conducted in compliance with ethical and regulatory standards. Participants are fully informed prior to enrollment, have the right to withdraw at any time, and their personal information is protected in accordance with applicable regulations.
Support for <br> Study-Related Costs

Support for
Study-Related Costs

Depending on the study, participants may receive support for certain costs incurred during their participation in the clinical trial.
Contribution to <br>Medical Science and Public Health

Contribution to
Medical Science and Public Health

Participation in clinical trials contributes to the generation of important scientific evidence, supporting the development of new treatments and the advancement of healthcare for future patients and the broader community.