Taking Part In a Clinical Trial
All Focus On articles are contributed by
Ms Low Ai Lin
Senior Manager, Clinical Trials Office,
Division of Clinical Trials and Epidemiology, NCC

Clinical trials are vital to the development of new drugs and other new treatments. Clinical trials take the latest innovations on the scientific frontier and apply them to patient care. Each clinical trial answers scientific questions and is used to ensure that a new drug or treatment is both safe and effective. By taking part in a clinical trial, one can contribute to the better understanding of how a treatment works in people of different ethnic backgrounds and genders. Clinical trials also give patients access to promising new treatment methods that are often not available outside the clinical trial setting and enable patients to receive regular medical attention from the research team of doctors and other health professionals. For some trials, treatment costs can be lessened since some costs are paid for by the trial.

Participants of clinical trials are volunteers. For each trial, there is a set of defined criteria to fulfill before one can be enrolled into the trial. Apart from Phase I trial using healthy volunteers, all other phases of trials also require interested patients to have a specific condition and must have certain symptoms before they can be enrolled. Hence, if consent for participation is obtained, a healthy volunteer or a patient must undergo screening tests and procedures to ascertain his or her eligibility for enrolment.

It is important to obtain sufficient information and have a thorough understanding of the various issues associated with the clinical trial that one wishes to participate before making the decision to become a participant or trial subject. It is best for a patient to discuss first with the patient’s attending doctor about the interest, so that the doctor could refer the patient to an appropriate trial investigator. The patient can then obtain more information on the trial specifics from the trial investigator.

Below are some questions that may help a trial subject obtain information from the investigating doctor or the trial nurse:

• What is the purpose of this trial?
• Has the study drug or treatment being tested to be effective?
• Who is sponsoring the trial?
• Who has reviewed and approved the trial?
• How are the study results and safety of participants being monitored?
• How long will the study last?
• What will happen at the end of the study or if I withdrew from the trial?

• What are the possible short-term and long-term benefits?
• What are the short-term and long-term risks?
• What other treatment options are available?
• How do the possible risks and benefits of the trial compare with those of other options?

• What kind of treatment, tests and procedures will I have during the study
• How often and how much time is needed to do these?
• Will treatment, tests or procedures be painful? If so, how can the pain be controlled?
• How do the tests in the study compare with what people might receive outside the trial?
• Will I be able to take my regular medications while in the trial?
• Will I need to be hospitalized for the trials? If so, for how long?
• Who will be in-charge of my care? Will I be able to see my own doctor?
• How long will I need to stay in the trial and will there be follow-up visits after the trial?

• How would being in the study affect my daily activities?
• What support is available for me and my family?
• Can I talk with people already enrolled in the study?

• Will I have to pay for any treatment, tests or procedures. If so, what will the approximate charges be?
• What are the likely charges that can be covered by my health insurance / health protection plan?

There are possible setbacks in participating in a clinical trial. New treatments and procedures may have side effects or risks unknown to the doctors. These new treatments and procedures are not always better than the standard of care to which they are compared with. They may be ineffective or less effective or may have side effects or risks that are worse than the standard care. In a randomized trial with two or more treatments, patients will not be able to choose the treatment that they want. Even if a new treatment is known to have benefits, it may not work for all patients. Thus many potential subjects are faced with this burning question – “Is there a system in place to protect participants in a clinical trial and to ensure that the trial is a worthwhile study that does not subject people to unnecessary risks?”