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A clinical trial is a research study conducted with human volunteers to evaluate the safety and effectiveness of new medical treatments, interventions, or therapies. Clinical trials are designed to answer specific research questions and may involve testing new drugs, medical devices, procedures, or behavioural interventions.

Each clinical trial has specific eligibility criteria that participants must meet to enrol. These criteria may include age, gender, medical history, current health status, and other factors relevant to the study. Eligibility criteria help ensure that participants are suitable for the study and that the results are valid and applicable.

Informed consent is a communication process between the study team and patients in which patients are provided with adequate information regarding the study, including potential risks and benefits. Patients should be given ample time to consider their decision to voluntarily take part in the study before signing the informed consent form after receiving all study-related information.

During a clinical trial, participants may undergo various assessments, tests, treatments, or interventions as outlined in the study protocol. This may include physical examinations, laboratory tests, imaging studies, medication administration, or behavioural interventions. The research team closely monitors participants throughout the study period.

It's important to understand that there is no guarantee that the medication/treatment being evaluated in the study will directly benefit the patient's medical condition. In fact, it may even cause serious side effects. Follow-up visits are more frequent for patients in a clinical trial and require more time and medical attention compared to standard hospital visits.

Participants in clinical trials are closely monitored for any side effects or complications that may arise during the study. If you experience any adverse events or symptoms, it is important to promptly notify the study team. They will provide appropriate medical care and may adjust or discontinue the study intervention if necessary.

The Sunway Medical Centre study team, Sunway Medical Research Ethics Committee (SREC), Regulatory Authorities and participating Sponsor will have access to your medical records and research data. However, rest assured that all medical records and research data will be kept confidential among the research team members only. All your information obtained will be kept and handled in a confidential manner, following applicable laws and regulations.

Participating in multiple clinical trials simultaneously is not recommended due to potential safety concerns and interference with study outcomes. However, exceptions may be made in certain circumstances with careful consideration and approval from the study sponsors and research team.

Clinical trials are regulated and overseen by regulatory authorities such as the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia and institutional review boards or ethics committees. These regulatory bodies ensure that clinical trials are conducted ethically, with participant safety as the top priority, and that they adhere to applicable laws and regulations.

Compensation for participating in a clinical trial varies depending on the study and its sponsor. Some clinical trials offer compensation for time and travel expenses, while others may provide additional incentives or reimbursements. The details of compensation will be outlined in the informed consent form provided to participants.

The duration of a clinical trial varies depending on the study design, objectives, and treatment regimen. Some trials may last for a few weeks or months, while others may span several years. The study duration will be clearly outlined in the study protocol and discussed with participants during the informed consent process.

Yes. You can withdraw your participation from a clinical trial at any given time. If you withdraw, any data collected from you up to your withdrawal will still be used for the study.

Yes, you can do so, as participation in a clinical trial is entirely voluntary. If you decide not to participate in the study, it will not affect your standard medical care.

If you have any questions about a specific study or want to know more about research/clinical trials, kindly send your enquiries via our contact form here.