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Is there any protection of my privacy?
Your privacy will be protected throughout the whole clinical trial. Any records that identify your personal information will be kept strictly confidential and will not be made publicly available. You will only be identified by using initials and numbers in the trial documents. If the results of the trial are published, your identity will also remain confidential....
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Am I allowed to quit from the clinical trial at any time?
Your participation in the trial is voluntary. You are free to withdraw/quit from the trial at any point of time and you do not need to give a reason. You can quit from the trial, at any time, without penalty or loss of benefits to which you are otherwise entitled, except for any benefits that you might have been receiving in connection with the...
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Will my medical expenses be covered throughout the clinical trial?
You will be compensated for your travel expenses when attending study visits for consultation appointment with your study doctor. The costs of study drugs and all medical tests/procedures that are required by the trial will be borne by the drug company that initiated the clinical trial. However, you will have to bear the costs for doctor visits, other treatments or tests that are not...
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Do I know which study drug/medication that I receive during the trial?
In a clinical trial, a group of patients will be given the real drug whilst another group of patients will receive a placebo (a dummy drug that looks similar to the real drug but have no effect). Neither you nor your study doctor nor his/her study staff will know which study drug you are receiving. In an emergency, your study doctor can find out...
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What do I need to do when participating in a clinical trial?
When you agree to take part in a clinical trial, you are expected to comply with the trial related procedures. You are required to attend the scheduled study visits for consultation appointment with your study doctor, follow-by trial treatment and procedures. You must take the study drug/medication as instructed by your study doctor. You must contact your study doctor and his/her study staff if...
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What do I need to know when participating in a clinical trial?
When you are asked to participate in a clinical trial, your doctor will talk to you regarding the research study. You will be given an information sheet about the research study and an informed consent form to help you decide if you want to participate in the clinical trial. Please take time to read the trial information carefully. You can ask your study doctor...
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Is it safe to participate in a clinical trial?
A clinical trial has potential benefits and risks. The study drug has already undergone a lot of testing and investigation to understand the drug safety and side effects. Your study doctor will inform you of the known risks and side effects of the study drug and trial related test procedures. You will be informed in a timely manner whenever new information becomes available that...
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Who is eligible to participate in a clinical trial?
There is a set of inclusion and exclusion criteria that a study doctor must follow when identifying, selecting and recruiting suitable patients for a clinical trial such as age, gender, type and stage of a disease, previous treatment history and other medical conditions. You will only be eligible to take part in a clinical trial if you fulfill all the inclusion criteria and none...
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Who is responsible in conducting a clinical trial?
Study doctor is responsible for the conduct of a clinical trial. He/she is qualified by education, well-trained and experience to assume responsibility for the proper conduct of the trial. The study doctor will provide medical care to trial patients and ensure patients safety and well-being are protected....
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What are the risks and benefits of a clinical trial?
Before a clinical trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial patient and society. A clinical trial should be initiated and continued only if the anticipated benefits justify the risks. The rights, safety and well-being of the trial patients are the most important considerations and should prevail over interests of science and society. ...
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