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.

  • Step 1
    Informed Consent
    Before 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.
  • Step 2
    Screening and Enrollment
    Researchers 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.
  • Step 3
    Study Procedures & Intervention
    After 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.
  • Step 4
    Monitoring & Follow-up
    Volunteers 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.
  • Step 5
    Reporting Adverse Events
    If 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.”
  • Step 6
    Communication & Support
    Constant 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.
  • Step 7
    Trial Completion & Follow-up
    Trial 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.

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.

Known as “exploratory studies”, Phase 0 clinical trials are the first-in-human trials involving a subtherapeutic dose of an investigational drug. These trials gather preliminary data on the drug’s pharmacokinetics (how the drug is processed in the body) and pharmacodynamics (how the drug affects the body), typically with a small number of participants.

Days – Weeks

Days – Weeks

Phase 1 clinical trials focus on assessing the safety, tolerability and dosage of a new drug or treatment in humans. These trials involve a small group of participants, often healthy volunteers, to determine side effects and the drug’s metabolism and excretion patterns.

Weeks - Months

Weeks - Months

These trials assess the drug’s efficacy and further evaluate its safety in a larger group of participants. The main objective is to determine the optimal dosing of a medical intervention by monitoring its effects and safety in humans.

~ 2 years

~ 2 years

Large-scale Phase 3 trials assess a drug’s effectiveness, side effects and comparison to existing treatments over years. After completion, data is submitted to regulatory bodies for potential approval.

Several years

Several years

Post-marketing surveillance trials occur after drug approval and involve thousands over many years to monitor long-term safety, detect rare side effects and compare the drug to other available treatments.

Several years

Several years

Phase 0
Phase 1
Phase 2
Phase 3
Phase 4

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.

What does participating in a trial mean for me?

Benefits

Access to New Treatments
Participants can receive new treatments that are not yet available to the general public.
Close Monitoring
Participants receive regular follow-ups from the research team to ensure their well-being and safety during their participation period.
Contribution to Medical Research
Participation helps advance medical science and can lead to the discovery of new effective treatments for others in the future.
Cost Coverage
Often, the treatment, tests and medical care related to the trial are provided at no cost to the participant.
Potential for Personal Benefit
While not guaranteed, some participants may experience improvement in their condition or symptoms.

Risks

Unknown Side Effects
As the treatment is new, there might be unexpected and potentially serious side effects.
No Guaranteed Benefit
The new treatment might not be effective, or it might not be better than the current standard treatment.
Time Commitment
Participation may require frequent visits to the study site, hospital stays or complex dosage requirements.
Potential Costs
Some trials might not cover all expenses, leading to out-of-pocket costs for participants.
Placebo Possibility
In some trials, participants might receive a placebo (a treatment with no therapeutic effect) instead of the active drug, meaning they might not receive any direct benefit from the trial.

Join Clinical Trials

If you are keen on volunteering for a clinical trial, view the ongoing trials in Singapore that are actively seeking participants.