What is clinical research?

Clinical research refers to the entire process whereby a drug is incepted in the lab and eventually introduced to the consumer market. Promising drug candidate identified in lab is subjected to pre-clinical studies and animal studies for safety and toxicity tests before permission from regulatory authorities is obtained to initiate trials on human subjects.

What is a clinical trial?

There are four phases of clinical trials, each having a different aim.

• Phase I – Phase I studies are the first stage of testing in human subjects to test for the safety, tolerability and the general mechanism of action of the drug in humans. The drug is administered to a small number of healthy volunteers to determine the dose tolerability in human subjects. Currently, KTPH does not conduct Phase I studies.
• Phase II – Phase II studies determine the efficacy of the drug or device with volunteers with a specific disease.
• Phase III - Phase III studies determine the safety and efficacy of the investigational drug or device in different clinical settings. The outcome of the trial would be used for the basis of labeling in the market.
• Phase IV – Phase IV studies determine long term safety and new indications to the label after it is cleared by regulatory authorities for marketing.

Who can participate?

All clinical trials have guidelines on participants of clinical trials called the inclusion/exclusion criteria. These criteria are based on factors like age, gender,  the type and stage of a disease, previous treatment history and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, they are used to identify appropriate participants to ensure their safety and well-being. The criteria also help to ensure that researchers will be able to answer the questions they plan to study.

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

Benefits:

Well-designed and well-executed clinical trials are the best approach for eligible participants to:

• Play an active role in their healthcare by speeding up potentially more effective new treatments
  
• Contribute to research efforts that can lead to potentially better health treatment for themselves and their future generation
  
• Gain access to new and potentially more effective treatment before they are widely available
• Receive expert medical care at leading health facilities during the trial

Risks:

Clinical research, like medical treatments, always involve risks.

• There may be unpleasant, serious or even life-threatening side effects resulting from the treatment.
• The new treatment may not be as effective as currently available treatments.

How is the safety of participants protected?

All clinical trials are regulated by the Medicines Act 1975 and the Medicines (Clinical Trials) (Amendment) Regulations 1998. In addition, research studies conducted in KTPH must seek ethics approval from an independent ethics committee called the Domain Specific Review Boards (DSRB). The committee includes medical doctors, paramedical staff, statisticians and volunteers from the public who collectively review all research proposals. The rights, safety and wellbeing of trial participants are the most important considerations and prevail over interests of science and society.

Before a trial is initiated, a detailed research proposal is to be submitted for ethical review to the DSRB. As a clinical trial progresses, study status reports will be submitted periodically to DSRB and if necessary, random audits will be conducted to ensure protocol compliance. Individual participants’ names will not be reported to protect participants'confidentiality.

What should people consider before participating in a trial?

Before participating in a trial, potential participants should know as much as possible about the trial. He or she should feel comfortable raising questions and concerns pertaining to the trial to the study team. Below is a list of some questions that can help in understanding a trial before participating:

• What is the purpose of the study?
• Why do researchers believe the new treatment being studied may be effective, or more effective than standard treatment? Has it been tested before?
• What kinds of tests and treatments are involved?
• Were there any serious side effects in pre-clinical studies?
• How do the possible risks, side effects and benefits in the study compare with my current treatment?
• What minor side effects should I be aware of?
• How might this trial affect my daily life?
• How long will the trial last?
• How will I know that the treatment is effective? - Will results of the trials be provided to me?
• Will I be informed of updates in any new available treatment?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for expenses?
• Can I withdraw from the trial after it has begun?
• Will I be denied medical care if I withdraw from trial?

Who pays for clinical research?

The hospital funds promising clinical studies initiated by doctors as part of our ongoing commitment to promote, develop and provide health-related services that will benefit the Singapore community. Additional funding may come from government organisations, such as National Research Foundation (NRF), National Medical Research Council (NMRC) or private industry (via pharmaceutical and biotech companies).