Participating in Clinical Trials
A Clinical Trial (also called medical research, research study, or clinical research) is a research study to answer specific questions (e.g. safety, efficacy, etc.) about new drugs/therapies or new ways of using existing treatments.
Choosing to partake in a clinical trial is an important decision and is entirely voluntary. The section “understanding clinical trials” may help you understand better what clinical trial is about before making a decision to participate (or to continue participate) in a research study. You shall contact the clinical trials coordinator or investigator (or study doctor, i.e. physician who is responsible for the study) to find out more about the study and ask questions to clear your doubts. A “patient information sheet & consent form” containing information of the purpose of the research, detail of new drug/treatment, possible benefits and risks or side effects, procedures involved, etc. can be obtained from the coordinator or investigator. It is often helpful to discuss with your family physician, or family members about the trial with this “patient information sheet” in hand. If necessary, a conference between you, your family members/ physician and the investigator can be arranged to help reaching a decision.
When you agree to take part in a clinical trial after the investigator have explained to you the study detail and answered all your queries, you will need to give consent by signing and dating on the “patient information sheet & consent form”. A copy of the signed and dated consent form will be given to you for your retention and future reference. If there were any new information that were learnt by the researcher during the course of the clinical trial, you will be informed. These new information may or may not affect your decision to continue participation in the the trial, and you can discontinue the trial at any time without penalty. When withdrawing from a trial, you should let the investigator/coordinator know about your decision and the reason(s) for leaving the study. Often, depends on the design of the trial, you can choose to discontinue the study drug/treatment but continue to be follow-up by the the study team. This is usually carried out via telephone interview or clinic visit, to obtain your current health information after discontinuation of the study treatment.
Once you are in a study, it is important to keep your family physician informed of the new drug/treatment you are taking, to help him/her better manage your health and to prevent prescription of prohibited concomitant medication that may interfere with the study, or worse, risking your health. Nowadays, most of the clinical trials do have a patient study card (or patient ID card) to be distributed to each participant. This card contains important information of the study drug/treatment, and include information on prohibited therapies (if any) and contact of the research staff (coordinator and/or investigator). You should carry this card with you all the time (just like you carry your IC/driving licence) and show it to the nurse/physician every time you visit a clinic or hospital. If you do not have the card or have lost it, please ask one from the clinical trials coordinator.
It is paramount to be completely truthful with your study doctor regarding your health/medical history. Any undisclosed information may lead to inappropriate management that could be harmful to your health. Remember, one can only participate in one clinical trial at a time. Participation in more than one clinical trial involving study drug/treatment at the same time is not permitted as this could results in inaccuracy of data analysis in terms of safety and efficacy. Please inform the study coordinator if you are currently participating in another clinical trial before joining a new study. You may enter another clinical trial only when your existing study involving a novel drug/therapy has ended, and fulfill all criteria of the new trial that you are interested in.