What is a clinical trial?
Clinical trials are research studies designed to answer specific questions about investigational drugs that may benefit future patients and current research participants. The trials are designed to assess both the safety and effectiveness of new drugs in humans. Clinical trial is conducted in phases. There are four phases (Phase I, II, III and IV) of clinical trial, each phase with different purposes and durations. Phase I trials generally involve healthy volunteers whilst Phase II, III and IV trials involve patients with diseases. At each phase, researchers try to answer different questions about the new drug they are investigating. Progression from one phase of a clinical trial to the next phase generally requires success in the prior phase.
How is a new drug/medicine developed?
An experimental drug/medicine must first goes through rigorous testing in the laboratory. If the experimental drug/medicine has the potential to treat illness, it will undergo animal testing (also known as preclinical/non-clinical studies) to investigate the safety, toxicity and effect of the drug. The experimental drug/medicine must pass the animal testing before it can be tested in human. It can take an average of 13 years to develop a new drug/medicine, from identifying a new compound to testing it in clinical trials and making it available to the public.
How long is a clinical trial?
Generally, Phase I trials are conducted over several months (six to nine months) whilst Phase II trials take six months to three years. Phase III trials tend to be of longer duration, lasting one to four years. Phase IV trials are conducted after the new drug has been marketed and the duration of the trials may last two to five years or longer.
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. A clinical trial may bring possible benefits to trial patients. The patient may have the opportunity to access new, potentially promising drug and treatment that are currently only available in a clinical trial setting. If the new studied drug and treatment is working effectively to improve the patient medical condition, then the patient will have benefited from it. However, there are some possible risks in clinical trials. New drugs are not always better than the standard of care treatment. New drugs may cause unexpected side effects in the trial patients. Sometimes, the new drugs may not work for some patients. The patients may need to have more frequent visits to the doctor with more tests and treatments. A clinical trial is performed under closed monitoring of a team of research doctors and healthcare professionals to safeguard trial patients’ safety and well-being.
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.
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 of the exclusion criteria.
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 may be relevant to your safety and your willingness to continue participation in a trial. Throughout the clinical trial, you will be assessed carefully for any side effects and you will be treated accordingly. You will be closely monitored by your study doctor and his/her study team, with extra follow-up care provided to ensure your safety and well-being. Your participation in the clinical trial may be terminated at any time if it is determined by your study doctor to be in your best interest, safety and well-being. Patient rights, safety and well-being are primary emphasis in a clinical trial.
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 and his/her study staff about the trial and any questions that you have. You can also discuss the trial with your family members. Your participation in a clinical trial is voluntary. You are free to say yes or no. If you decide to take part in a clinical trial, you will be asked to sign and date an informed consent form. By signing an informed consent form, you voluntarily confirm about your willingness to participate in the trial. You will be given a copy of the signed informed consent form for your safe keeping.
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 you are ill or injured during the trial. You will be carefully monitored during your participation in the trial to ensure your safety and well-being.
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 what drug you are receiving.
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 part of the trial. An adequate trial insurance coverage will be secured by the drug company. If you become ill or injured due to the study drug/medication, your hospitalization and medical expenses will be covered by the drug company. You will be paid for reasonable medical expenses of trial related illness or injuries.
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 trial.
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.