VOLUNTEERS

 Clinical Trials & You

You are going for surgery and the surgeon gets to work without anaesthetic. That would be the reality if not for clinical research. From new medications and surgical techniques to high-tech medical equipment, advances in medical care and improvement to our health are products of clinical research. And without volunteers, none of this would have been possible.

At SingHealth IMU, researchers conduct early phase clinical trials to test which drugs or tests are more effective than others. Most of these trials require the participation of healthy volunteers.

Only after several phases of trials have been completed can a new drug or test be made available to patients who may benefit from it.

By participating in a clinical trial, you can be the seed of new treatments and even cures that bring new hope to patients.

 

Why we need volunteers for clinical trials?


Volunteers form the basis of clinical trials and their participation is crucial.  Researchers need data and materials from volunteers – both healthy individuals and patients with specific medical conditions – to be able to answer questions about health and disease, such as: 
 
Does this potential new treatment work better than existing ones?
 
Is this a more effective way of diagnosing diseases and health problems at an earlier stage? 

Potential new treatments are first studied in the laboratory and in animal models to help gather as much information as possible about them. If this information shows promise, then the potential new treatments are then tested in human volunteers. 

The first stage of clinical trials usually involves testing in healthy volunteers, and starts with very small doses to observe the safety and effectiveness of the potential new treatment in humans.  As the research progresses, it is introduced to patients with the medical condition it is intended for and tested in more people to ensure that it is effective and safe. 

Because SingHealth IMU focuses on early phase clinical trials, most of the studies the unit conducts require the participation of healthy volunteers. Most of our trials investigate potential new treatments and tests, such as biomarkers.

 

What are clinical trials?


A clinical trial is a medical research study that uses volunteers to test a new drug or screening tool.
Clinical trials are roughly split into four phases:

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Phase I

Also known as a proof-of-concept or first-in-man study. This is the first time that a potential new treatment is tested in humans. Phase I trials involve only small groups of volunteers and aim to establish how a new drug is absorbed and processed by the body and whether it is safe. These trials generally last only a few weeks.
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Phase II

This phase involves more volunteers and tests whether the new drug is effective and safe.
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Phase III

This phase involves thousands of patient volunteers who suffer from the condition the new drug is aimed at and can last several years. Phase III trials often randomise patient volunteers to different study arms, so that researchers can learn whether the new drug is better than existing treatments. After phase III trials are completed, all the data that has been collected is submitted to regulatory bodies, such as the US Food & Drug Administration or the Health Sciences Authority in Singapore, for approval. If the regulatory body approves the drug, it can be sold to patients.
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Phase IV

This phase is also known as the post-marketing phase. This evaluates how effective the drug is when used by patients in non-clinical trial situations. These studies involve tens of thousands of people and can last several decades.