
What Is a Clinical Trial?
A clinical trial is a research study conducted on human to investigate the effectiveness and safety of a medical intervention. This medical intervention could be a new or improved drug, device or medical procedure that affects human health outcomes. Thus, people volunteered to participate in clinical trials to help researchers find answers to specific health questions about the new medical intervention.

Why Are Clinical Trials Important?
Clinical trials serve as a crucial research tool in advancing medical knowledge and enhancing patient care. It helps the researchers to know what does and doesn’t work in humans, and whether the new approach is safe and works well for certain illness or groups of people.
A clinical trial will help to :
- Assess the safety and effectiveness of new medical interventions;
- Bring new medical interventions to market;
- Improve the standard of healthcare; and
- Provide more treatment options that are safe, effective and potentially cost-saving
Without clinical trial, progress in medical research would be significantly hindered, resulting in limited healthcare options. Medical professionals and patients would then need to rely only on existing standards of care with fewer possibilities of improvement.
While clinical trials are important, ensuring the well-being, rights, and safety of the human volunteers in the clinical trial are equally important. There are various regulations and policies in placed to ensure the clinical trials are ethical and rights of human volunteers are protected. Click here to find out more.
Clinical Trial Process
Clinical Trials adhere to a safety-focused protocol detailing study length, participant eligibility, research methods, interventions and follow-up procedures. Key steps include Informed Consent, Screening, Enrolment, Monitoring, Adverse Event Reporting and Trial Completion.
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Step 1Informed ConsentBefore the trial commences, volunteers undergo the Informed Consent process where they receive comprehensive details about the trial, including responsibilities, risks, benefits and alternative treatments. After addressing any concerns, they sign a consent form. However, volunteers have the rights to withdraw from the trial anytime without penalties.
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Step 2Screening and EnrollmentResearchers meticulously screen volunteers based on criteria like age, gender, illness type and stage, treatment history and other medical conditions. Those meeting the protocol’s requirements are then enrolled in the clinical trial.
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Step 3Study Procedures & InterventionAfter enrolment, volunteers undergo study procedures as per the trial protocol. They might be randomly assigned to treatment groups: the trial group receiving the new treatment or the control group getting the existing treatment or a placebo.
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Step 4Monitoring & Follow-upVolunteers are monitored through multiple visits to assess their wellbeing. Often, researchers remain unaware of a volunteer’s group assignment (trial or control) until the study concludes, ensuring unbiased results.
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Step 5Reporting Adverse EventsIf an adverse event/side effect arises during or after the trial participation, it will be closely follow-up by the research team and treatment will be provided when deemed necessary.”
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Step 6Communication & SupportConstant communication between the volunteer and the research team occurs throughout the entire clinical trial, to ensure the proper conduct of the trial, and the volunteer’s safety.
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Step 7Trial Completion & Follow-upTrial completion and follow-up visits, if any, will be clearly stated in the Informed Consent Form (ICF). The procedures to be conducted during these visits will be informed in the ICF too.
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How Does a Clinical Trial Work?
All clinical trials of new medicines go through a series of phases to test whether they're safe and whether they work. The medicines will usually be tested against another treatment called a control. This will either be a dummy treatment (a placebo) or a standard treatment already in use.
Days – Weeks
Days – Weeks
Weeks - Months
Weeks - Months
~ 2 years
~ 2 years
Several years
Several years
Several years
Several years
How Does a New Medical Treatment Get
Approved by Regulatory Authorities?

The Health Sciences Authority (HSA) and Institutional Review Boards (IRBs) play crucial roles in the approval and oversight of new treatments in Singapore. While HSA meticulously reviews clinical trial data to ensure that new medical interventions meet stringent safety and efficacy standards, IRBs evaluate the ethical aspects of these trials, ensuring the rights and welfare of participants are protected. Their combined efforts ensure that only treatments with proven benefits and manageable risks are introduced to the market, safeguarding the health of Singaporeans. For a comprehensive understanding of HSA’s processes and the role of IRBs, kindly visit the official HSA website.