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FAQs on Clinical Trials

What is a clinical trial?

A clinical trial is generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Some trials also evaluate the safety and efficacy of promising investigational drugs or medical devices for new treatments or procedures before they can be marketed.

Why participate in a clinical trial?

Participants in a clinical trial can play a more dynamic role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Participation in clinical trials is strictly on a voluntary basis.

What are the benefits and risks of participating in a clinical trial?

Benefits

  • It allows you to gain access to new research treatments before they are widely available and help others by contributing to medical research.
  • It also allows you to play an active role in your own health care management.

Risks

  • You may experience some unpleasant, serious or even life-threatening side effects during the treatment course.
  • The new treatment may be less effective than the standard treatment.
  • The trial may require more of your time than your standard treatment. (More frequent trips to the hospital, more treatments, extra hospital stays or complex dosage requirements.)

What should people consider before participating in a trial?

If you are keen to participate in the clinical trial that has offered to you, you should know as much as possible about the trial and feel comfortable asking the members of the health care team questions about it. Please aware that the experimental treatment being tested may or may not help you. You may get better, you may see no change or may get worse. Your involvement helps doctors learn about the treatment being tested. This knowledge may help many patients in the near future. Some trials offer experimental treatments that you cannot receive outside the trial. Other trials compare standard treatments that you may be able to receive without being in the trial.

The following questions might be useful when you discuss with your trial team. Most of the information can be found in the informed consent form.

Experimental Treatment

  • What is the aim of is study?
  • Which other countries are involved?
  • Why do researchers believe that the experimental treatment being tested may be valuable? Has it been tested before?
  • What kind of experimental treatments are involved?
  • How will I know that the experimental treatment is working?
  • How might this trial affect my daily life?
  • What is the duration of this trial?
  • Who will be in-charge of my care during/after the trial?

Health Issues

  • What is the standard treatment?
  • What are the risks of not being on standard treatment?
  • Will my present health condition get worse?

Side Effect

  • Will there be any side effects?
  • What kinds of side effects are likely to be expected?
  • Who should I contact if I suffer from the side effects?

Finances

  • Who will pay for the experimental treatment?
  • Will there be any reimbursement for other expenses?
  • Will I be covered if I am hospitalised due to the experimental treatment?
  • Will I continue to be provided with the experimental drugs after the trial is completed?
  • Will I get free or subsided experimental drugs after it is approved for marketing in the country?

Who can participate in a clinical trial?

Those who meet the protocol stated inclusion and exclusion criteria are eligible to participate in a trial. Some research studies seek participants with illness or conditions to be studied in the clinical trial, while others need healthy volunteers. It is important to note that inclusion and exclusion criteria are not used to reject people personally but rather to protect the participants’ safety and ensure that the researchers will be able to answer the research questions they plan to study.

What are your responsibilities of participating in a clinical trial?

Participants should follow the advice provided by the trial team and make every possible effort for all the visits and procedures that are outlined in the informed consent form. If a participant does not comply with the trial requirements, depending on the severity, the trial team has the right to end his/her participation in the study.

What happens during a clinical trial?

Different trials are being conducted differently. The clinical trial team usually includes doctors (investigator), a research coordinator and some other healthcare professionals. They screen the participants strictly according to the protocol inclusion and exclusion criteria. They check the condition of participants at the beginning of the trial, give specific instructions to be followed and monitor them carefully during and until the trial has completed.

Clinical trials usually involve more tests and frequent clinic visits than the participants would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is strictly followed and there are frequent contacts between the participants and the trial team.

How is the safety of the participant protected?

Clinical trials must be conducted following rules that safeguard patients’ safety. Ethical and legal codes that govern medical practice also apply to clinical trials. All clinical trials conducted in Singapore must be approved by an Institutional Review Board (IRB)/ Ethic Committee (EC).

The IRB reviews the trials to ensure that they are ethical and that the participants’ rights, safety, confidentiality and well-being are protected. In addition, it also monitors all clinical trials are compliant with the International Good Clinical Practice (GCP) guidelines.

The IRB is composed of medical doctors, paramedical staff, people of other professions, such as lawyers, teachers etc. who collectively review all trials related issues. Throughout the trial, the investigators make reports to the IRB. The IRB can stop a trial at any time to safeguard the participants.

For trials involving the use of drugs, a valid Clinical Trial Certificate must also be obtained from the Singapore Health Science Authority (HSA).

What happens if I suffer an adverse event or an emergency while participating in a clinical trial?

If you experience any unpleasant adverse reaction or require any emergency attention during the trial period; you should inform the treating doctors and contact the trial team through the trial coordinator immediately. The contact details are usually in the Informed Consent Form.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by various organisations or professional bodies like pharmaceutical companies, hospitals, foundations, voluntary groups and government agencies.

Where do the ideas for trials come from?

Clinical trials are mainly the results of new ideas formulated by researchers or research groups. If a new drug or device is involved, extensive tests in the laboratory and in animal studies are done to select the most promising drugs or devices to proceed to human trials. During a trial, progressive information is gained about an experimental treatment, its risks and how well it may work.

What are the different types of clinical trials?

  1. Treatment trials test experimental treatments to determine whether a new treatment, new combination or combinations of drugs, new approaches to surgery or new radiation therapy is safe and effective.
  2. Preventive trials look for better ways to prevent disease. These researches are on drugs, vitamins, vaccines, minerals and lifestyle changes.
  3. Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  4. Screening trials test the best way to detect certain disease or health conditions.
  5. Epidemiological trials try to answer health issues in large groups of people or populations in naturals.
  6. Quality of life trials explore ways to improve comfort and the quality of life for individuals with a chronic illness.

What are the phases of clinical trials?

Clinical trials are conducted in phases. Each phase has different purposes and helps researchers answer different questions.

  Phase 1  Phase 2  Phase 3  Phase 4 
Description  • To assess the tolerability of new drug through adverse events, clinical and laboratory parameters and toxicology
• Determine a safe dosage range, and the effects of food/drug-drug interaction
• Proof of concept, dose-range finding or definitive dose-response studies
• To determine the minimum and maximum effective or tolerated dose
• To confirm effectiveness
• To monitor side effects
• To compare against commonly used treatments
• Usually for post marketing safety surveillance
• Sometimes conducted to provide additional details on drug’s long- term safety, efficacy and cost effectiveness
• To determine new dosage forms or formulations
Patient population • Usually healthy volunteers • Well-controlled within a narrowly defined population • More varied disease population  • Varies accordingly 
What to expect  • Often requires many physical examinations and tests (blood test, ECG, etc.)
• Usually conducted at a single geographical site
 • Often requires many physical examinations and tests (blood test, ECG, etc.)  • Usually randomized
• Usually double-blinded
• A certain percentage on standard treatment(s) and the rest on new treatment(s).
• Multi-centred study
• Usually open-label trial
• Duration of the trial is relatively short

What is informed consent?

It is a process in which the trial team members (doctors, nurses) provide adequate trial information (details about trial purpose, duration, required procedures, potential risks and potential benefits) to the participant before the participant decides whether or not to participate the trial. The participant will be given sufficient time to think and is encouraged to ask as many health and trial related questions as possible before making the final decision. Informed consent is not a contract, and the participant is free to withdraw from the trial at any time and will not be penalised in doing so. Participants should let the trial team know about the decision and they are encouraged to share the reasons for leaving the trial.

What is a protocol?

A protocol is a study plan on which the clinical trial is based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions.

A protocol will describe the aim of the study, inclusion and exclusion criteria of the participants, the schedule of tests, procedures, medications, dosages and length of the study. Trial participants need to be monitored by the trial team (investigator/doctor, research coordinator and sometimes other healthcare professionals) regularly according to the protocol schedule on their health, safety and effectiveness of their trial treatment.

What is a placebo?

It is an inactive concoction that has no treatment value. In clinical trials, experimental treatments are frequently compared with placebos to evaluate the treatment’s effectiveness.

What is randomisation?

A method of selecting participants based on chance by which study participants are distributed into one of two or more treatment groups. You may receive the treatments being tested or you may receive a standard treatment or even a placebo. The researchers do not know which treatment is superior and any of the treatments chosen could be of benefit to the participants.

In some studies, the actual treatment you receive is kept unknown. These are called blinded studies:

  • In a single-blind trial, patients do not know which treatment they are receiving;
  • In a double-blind trial, neither the patient nor their doctors know which treatment the patients are receiving. In an emergency, when participant’s life is threatened, the doctor can request from the sponsor to un-blind the treatment for further management of the condition.

There are also studies in which the investigators and participants know which drug is being administered. These are known as open-label trials.

Where can I learn more about the trials available in SGH?

Visit the Clinical Trials and Research Centre located at Block 6 Level 1, call 6321 3652 or email grcctrc1@sgh.com.sg.

Last Modified Date :09 Dec 2016