Clinical Trials and You

To help you decide whether you would like to take part in a clinical trial, here's an introduction to clinical trials as well as answers to some questions that you may have.

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:

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

At SingHealth IMU, we specialise in early phase or Phase I clinical trials. Some of these require the participation of healthy volunteers to investigate potential new treatments and tests, such as biomarkers. Some trials however, for e.g,. in the area of cancer, will involve patient volunteers.

Before a trial is conducted at our unit, the potential new treatment is first studied in the laboratory and in animal models to help gather as much information as possible.  The trial is then moved into the human phase only if it shows promise in animal phase.
 
All clinical trials are reviewed by the SingHealth Centralised Institutional Review Board (CIRB) to ensure that the interests and safety of volunteers are protected. Clinical trials must prove that the potential benefits outweigh the potential risk before approval is given for the trial to start.

Early phase 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. 

A new drug or test will only be made available to patients who may benefit from it after several phases of trials have been completed, and this usually takes many years.

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