Frequently Asked Questions
Choosing to participate in a research activity is a very important decision.
The following information is written with the aim to help you understand the issues surrounding research and perhaps address some concerns relating to participating in research.
It is often helpful to talk to a doctor, family members, or friends about deciding to join a research study.
About Clinical Research
What is Clinical Research?
Clinical Research is research conducted in human volunteers to answer scientific health questions. Clinical Research helps to determine the safety and effectiveness of experimental drugs or devices. Clinical research is commonly described as a “Clinical Trial”, “Clinical Study” or an “Experiment”. Clinical Research is not the same as Clinical Treatment.
Why is Research important?
Research is an essential process in the search for better, faster and cheaper alternatives to existing treatment and diagnostic options. Research has the potential to uncover important knowledge that can improve our quality of life.
What are the various types of Research?
There are many unanswered questions in healthcare. Research studies are designed to answer some of these questions. The research design varies with the research question being asked. Some of the more common types of research are:
Interventional research is designed to determine whether a new treatment, new combination of drugs, a new device, a new surgical intervention, or new radiation therapy is safe and effective.
Prevention research is designed to look for better ways to prevent disease. These include research on drugs, vitamins, vaccines, minerals, and lifestyle changes.
Diagnostic research studies are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening research studies test the best way to detect certain diseases or health conditions.
Epidemiological research tries to answer health issues in large groups of people or populations in natural settings.
Quality of Life research explores ways to improve comfort and the quality of life for individuals with a chronic illness.
What happens during a Research Study?
The Research Team, which may include Doctors, Nurses and other healthcare professionals, will check the health of the Participant at the beginning of the Research Study and screen the Participant using specific inclusion / exclusion criteria.
A Participant who is found to be eligible will be enrolled into the research study, should he or she consent to participate in the research, and the research team will perform the research related activities according to the research protocol. Research Participants might have more tests and doctor visits than patients who are not participating in the research.
What are phases of Clinical Trials?
The process of development of a new drug involves various phases. Before a drug is study in humans it undergoes extensive pre-clinical testing. Here is a simple description of the four phases of a clinical trial:
Phase I : This first phase is carried out to assess the safety of the new drug. Only small groups of volunteers (20-80) are recruited for this phase.
Phase II : Once a drug is shown to be safe in Phase I testing, it goes on to phase II trials to test the efficacy. In Phase II, a larger group (100-300) of patients with the disease is involved.
Phase III : During this phase, the drug efficacy is determined and larger group of population (1,000-3,000) is recruited. Results from phase III helps pharmaceutical drugs gain further knowledge on the drug's effectiveness, benefits and range of possible adverse reactions.
Phase IV :This phase is also known as the post marketing phase. Phase IV clinical aim to determine how a particular drug compares to other currently available drugs especially with regards to long term safety, efficacy and cost effectiveness.
What is Randomization?
In some Research Studies, Participants are randomised (equivalent to "tossing of coin") into treatment groups. In some of these studies, neither the Participant nor the Researchers may know what treatment the Participants would receive during the Research Study.
Who sponsors Research?
Research is sponsored or funded by various bodies such as hospitals, foundations, voluntary groups, and pharmaceutical companies, in addition to government agencies such as the A* STAR and National Medical Research Council.
Participating in Research
Why do people participate in a Research Study?
Who can participate in a Research Study?
Is it safe to participate in Research Study?
What is Informed Consent?
Clinical Research is research conducted in human volunteers to answer scientific health questions. Clinical Research helps to determine the safety and effectiveness of experimental drugs or devices. Clinical research is commonly described as a “Clinical Trial”, “Clinical Study” or an “Experiment”. Clinical Research is not the same as Clinical Treatment.
What should you consider before participating in a Research Study?
What are your responsibilities as a Volunteer Research Participant?
What are your rights as a Volunteer Research Participant?
What are the possible benefits of participating in a Research Study?
What are the possible risks of participating in a Research Study?
What happens if I suffer an Adverse Event or an Emergency while participating in a Research Study?