Clinical Research & Innovation Office

For Patients and Research Volunteers

There are three main types of research involving human volunteers in TTSH. They are:


These studies are managed by medical doctors, research scientists and research staff specially trained to conduct research. These trainings include understanding of regulatory requirements, ethical conduct of research and correct techniques to handle sensitive medical and research information. Research studies may involve new medications, novel surgical techniques, surgical instruments or medical devices.

Note that in all these research and clinical trials, even normal health volunteers may be involved in research. This allows us to compare research information results with those who have specific diseases.

 

Common questions and answer for clinical trials

 

1. The aims of research

Research aims to find out if a new treatment, medical procedure or instrument:
  • Is safe for clinical use?
  • Has any side effects?
  • Works better than the best currently available treatment or management?
  • Helps you recover better from your illness?

New treatments are thoroughly tested before being used by the general populations. For example, a new drug is first investigated in the laboratory and tested for potential use in human. These potential medications are being subjected to research studies under strict guidelines in human volunteers.

 

2. Who can participate in research?

All research studies has regulations and guidelines about who can participate in them. The use of inclusion and exclusion criteria (commonly known as “eligibility criteria”) is an important principle of medical research toproduce reliable results. Factors that allow someone to participate in research are called “inclusion criteria” while those that do not allow are called “exclusion criteria”. These criteria are based on several factors, including age, gender, the type and stage of a disease, previous treatment history and other medical conditions.

Before joining a particular research, a participant must qualify for the study. These criteria are used to identify appropriate participants to ensure valid study results. Guidelines are also drawn up to reduce the risks and side effects of any research. The criteria also ensure that researchers follow strict protocol in their research and ensure the safety of research study volunteers.  

3. What are the benefits of taking part in research?

  • To have access to new and potentially better treatments that may not be available to other patients in the general population.
  • For the peace of mind that comes from knowing your clinical tests are normal or that you can get early treatment if they are not.
  • Depending on different research, some offer free medical tests and medical care that comes with participation of research.
  • Ultimately, you are doing something important to benefit the future generation, including your current or future family members and relatives.
 

4. What are the risks of taking part in research?

  • There may be unpleasant, minor or serious side effects to research treatment.
  • The new treatment being studied may not be as effective as currently available treatment.
  • The protocol may require more time and attention than currently available standard treatment. Additional follow-up visits, treatment schedule or complex medication dosages may be needed.
 

5. What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the drug or treatment being studied, which may be short-term and long-term effects. These negative or adverse reactions may include headache, nausea, skin irritation, and other physical or medical problems.  

6. How do we protect the safety of the research participants?

Many of us worry that participating in medical research will involve taking unknown drugs of unknown dosages, or undergo unproven and dangerous treatments. Some are concerned if the research results are used inappropriately and worry about unauthorised access to these results or health information.

In TTSH, we have strict research ethical and legal codes, similar to those that govern medical practice of doctors in hospitals. In addition, there are many research regulations and guidelines in Singapore that protect the study research participants.

National Healthcare Group (NHG) Pte Ltd has instituted a comprehensive Human Subjects Protection Program to protect the safety and well being of research participants. For more information, click here.

All research studies conducted in Tan Tock Seng Hospital are governed by the NHG research regulations. These studies are reviewed by an independent ethics committee called the Domain Specific Review Boards (DSRB).The committee in DSRB includes medical doctors, paramedical staff, statisticians, and volunteers from the public who collectively review all research proposals. Their main job is to ensure that the research is ethical and all research participants’ rights, safety and welfare are protected.

All research studies must be approved by the DSRB before being allowed to be conducted in TTSH.  

7. What must you do before participating in any research?

If you are interested to participate in a research study, you must first find out more about the study details and level of your participation. The following questions may help you to discuss with the study research team. Many of the following information should also be found in the Patient Information Sheet of the study.

STUDY DETAILS:

  • What is the purpose of the research study?
  • What procedures will be followed in this study?
  • What are your responsibilities and duties in this study?

MEDICAL CARE:

  • What is not standard-of-care or experimental in this study?
  • Who will be in charge of your care?
  • Would you be able to continue to see your own doctor?
  • Who to contact if you have adverse events or side effects?

POSSIBLE RISKS AND BENEFITS:

  • What are the possible risks, adverse events and side effects?
  • What are the possible benefits from participating in the study?
  • Is it necessary to practice contraception during the study period?
  • What happens to your medical care if you do not participate in this study?

COSTS AND COMPENSATION:

  • What are the costs and extra payments if you participate in the study?
  • Can you stop participating at any time if you change your mind to take part in the study?
  • Is there any compensation for research-related injuries or side effects?

OTHER ISSUES:

  • How do the research investigators protect the confidentiality of your medical and research information?
  • Will you be told of the study results?
  • Can you get the study treatment or drugs after the study has ended?
  • Who are the team members and investigators involved in the conduct of this study?
 

8. What are my legal rights if I take part in a study?

  • The decision to take part in a study is entirely your voluntary decision.
  • No one can make or force you to participate.
  • Your medical care now, or in the future, will not be affected by your decision to participate.
  • You can stop the study at any time, as soon as you inform the research study team.
  • Similarly, you doctor in-charge or study team can stop your participation in a study at any time if it is in your best interest. This also occurs if you do not follow the study protocol or if the study is stopped by the research team.
  • You may be told of important new findings or any changes in the study.
  • Your confidentiality is protected.
 

9. What are the different types of clinical trials?

There are 4 phases of clinical trials. Each new medication or treatment being tested may be involved in any of these phases.

Phase 1: Assess Safety Profile of New Treatment

Once laboratory studies show that a new treatment has potential benefits, a phase 1 trial is conducted. A phase 1 trial is the first step in testing in humans. In these studies, researchers look for the best way to give people the new treatment (for example, by pills or by injection), how often it should be given, and what is the safest dose. These studies also include special laboratory tests such as blood tests and biopsies to evaluate how the new treatment is working in the body. Phase I trials involve a smaller group of people.

Phase 2: How Well the New Treatment Works

Phase 2 trials continue to test the safety of the new treatment, and begin to evaluate how well it works against a specific type of disease. In these trials, the new treatment is given to groups of people with one type of illness or related illness, using the dosage found to be safe in previous phase 1 trials. Phase 2 trials usually involve less than 100 participants.

Phase 3: Comparing a New Treatment to the Current Standard Treatment

Phase 3 trials focus on learning how a new treatment compares to the current standard, or the most widely accepted treatment. Researchers want to learn whether the new treatment is better than, the same as, or worse than the standard treatment.

In phase 3 trials, participants have an equal chance to be randomly assigned to one of two or more groups (also called "study arms") The process of assigning participants to groups is called randomisation, if a study has two groups:

  • one group gets the standard treatment (control group)
  • The other group gets the new treatment being tested (investigational group).
  • The investigation group is compared to the control group to analyse and study specific question regarding the new treatment
Phase 4: Continuing Evaluation

Phase 4 trials are used to further evaluate the long-term safety and effectiveness of a treatment. Less common than phase 1, 2, and 3 trials, phase 4 trials take place after the new treatment has been approved for standard use.

Summary of Phases of Clinical Trials  
Phase No. of Participants Goals /Aims
1 Less than 30 people
  • To find a safe dosage
  • To decide how the treatment should be given
  • To observe how the treatment affects the human body
 
2 Less than 100 people
  • To determine if the treatment or intervention has an effect on a particular disease
  • To see how the treatment or intervention affects the human body
 
3 Generally, from 100 to thousands of people To compare the new treatment, intervention or new use of an existing treatment with the current standard option
4 Generally, from 100 to thousands of people To further evaluate the long-term safety and effectiveness of a new treatment
 

10. Who sponsors research studies?

Research studies may be expensive to conduct due to needs for manpower, administration and regulatory requirement. They are sponsored by various sources. These sources include hospitals, private or public foundations, voluntary groups and pharmaceutical companies. Government-linked agencies may also be involved, including Agency for Science, Technology and Research (A*STAR) and National Medical Research Council (NMRC) in Singapore.