Before a new drug, biologic or medical device enters the consumer market, it has to go through a series of rigorous tests. The process begins with laboratory tests to identify active compounds and safety tests conducted in animals to determine potential risks. This is followed by clinical trials, in which new treatments are investigated for their safety and effectiveness in human volunteers who may either be healthy volunteers or patients diagnosed with the illness being studied.

Existing medications may also be investigated for use in a different disease (re-positioning) or compared against alternative treatments to optimise medical therapy.

All clinical trials are conducted by a close adherence to a protocol which ensures the consistency of trial procedures and the collection of reliable data. The protocol contains a set of criteria to define the population pool for the study. Parameters that allow participation in trials are called ‘inclusion criteria’ while those that prohibit are called ‘exclusion criteria’. These criteria usually specify the age, gender, the type and stage of a disease, previous treatment history and other medical conditions. These eligibility criteria also help to ensure the safety of research volunteers.

To find out if you are eligible for a clinical trial, contact CRIO or the doctor you are seeing at TTSH.

People who are considering participating in a clinical trial are usually concerned about the use of unproven drugs and the likelihood of dangerous side effects. They also worry about the misuse of research results and loss of confidentiality.

The National Healthcare Group (NHG) has set up a Human Research Protection Programme to promote high quality and ethical research under the oversight of the Domain Specific Review Board (DSRB). The NHG DSRB is an independent institutional review board consisting of medical doctors, paramedical staff, statisticians, and volunteers from the public who collectively review all research proposals. Their main responsibility 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 they are carried out in TTSH.

Informed consent is a process in which all aspects of the trial are explained to volunteers to help them decide whether or not to participate in a research study.

Matters pertaining to the trial such as study aims, procedures, duration of the study, anticipated risks and possible benefits, assurance of confidentiality of records and disclosure of alternative treatments are explained by the doctors and clinical research coordinators.

The information is documented in an informed consent form, and sufficient time is given to the research volunteers to read and understand the information conveyed to them.

Any queries raised will be answered. To confirm the volunteers’ willingness to participate in the trial, they sign and date the consent form. The informed consent form is not a contract and volunteers are allowed to withdraw from the trial at any time.

Yes, you may withdraw from a clinical trial at any time without penalty or compromise to the medical care you are entitled to.

Your responsibilities as a research volunteer are:

• To understand the information communicated to you during the informed consent process and clarify any doubts you may have before agreeing to take part in the study
• To be compliant with the study treatment and follow-up study appointments
• To adhere to the instructions in the study protocol
• To report any side effects or adverse events you are experiencing to the study team
• To answer research questionnaires truthfully to the best of your abilities

Risks

Research medications may have unpleasant, minor or serious side effects. The new treatment may not be as effective as currently available treatment. Your participation may require more of your time and attention than with currently available standard treatment. Additional follow-up visits, treatment schedule or complex medication dosages may be needed.

Benefits

You gain access to new and potentially better treatments that may not be available to other patients not on research trials. You also benefit from closer monitoring of your illness. All tests ordered for the purpose of research are paid by the people who plan and organise the project (also known as the sponsor), but some studies even pay for standard tests and treatment. Actually, the major satisfaction comes from knowing that you are contributing to medical advancement that will benefit future patients.