What is a clinical trial?
A clinical trial is a carefully designed research study that tests how well new medical approaches work in people. Clinical trials test whether new treatments are safe and effective. They are subject to various regulatory controls to ensure the safety of participants.
Phases of clinical trials
Medication and treatment clinical trials are divided into four phases. All new medications must be tested in phase 1, 2 and 3 trials before they can be approved for use by the general public.
Phase 1
After lab testing, the drug is tested on a small group of people for the first time to assess safety and identify side effects. These trials are short, highly controlled, and participants are closely monitored.
Phase 2
The drug is tested on a larger group to determine the optimal dose and further study its safety. Trials are short in duration, with participants under close monitoring.
Phase 3
The drug is tested on large groups to confirm effectiveness, monitor side effects, and ensure safe use. Randomized, placebo-controlled, blinded trials ensure accurate results.
Phase 4 trials
After regulatory approval, the drug is monitored in the general population for long-term safety, benefits, and risks.
What you can expect from you join a clinical trial
There are multiple reasons why people might choose to join a clinical trial. These include:
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Gain access to a potential new treatment
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Receive high quality clinical care through leading specialists and experienced investigators
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Medications and clinic reviews at no cost
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Receive payment for your travel costs and donated time
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The chance to contribute to science and help others
Who can participate in a clinical trial?
All clinical trials have rules about who can take part. These rules ensure that the trial is suitable for the patients who are enrolled in it, useful and reliable results can be obtained and that the risks are minimised.
These rules which are known as eligibility criteria specify which patients are suitable (inclusion criteria) or unsuitable (exclusion criteria) for the particular study. These criteria are based on predetermined factors such as age, gender, type of disease, medical history and current medical condition.
What are my responsibilities as a trial participant?
If you decide to participate in a clinical trial, you will be expected to:
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Maintain your own health and avoid unnecessary risks whilst on the trial
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Accurately report your medical history and the medications that you’re taking
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Advise your doctor know if you're taking anything else (including herbal medications, vitamin supplements, oral contraceptives, illicit drugs etc.)
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Adhere to all safety and monitoring requirements
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Attend all scheduled appointments
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Take trial medications exactly as prescribed
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Promptly report any untoward events/possible side effects during the trial
What are my rights as a trial participant?
You have the right to voluntarily participate in any research trial that you are eligible for and are interested in. You can choose to join or not join a trial without any pressure or influence from anyone.
You cannot be enrolled without giving your written informed consent. Informed consent means that you agree to participate in the trial after you have understood the information and have had the opportunity to ask questions.
You have the right to be informed of the risks, benefits and alternatives of the proposed drug or treatment in the trial. You should know about the potential harms and benefits in the study as well as other options is you choose not to join the trial.
If you decide to participate, and later change your mind, you can withdraw at any time. Whatever your decision, it will not affect your relationship with your health care team or with the hospital.
You have the right to privacy and confidentiality. Your personal and medical information is protected and should only be shared with authorised persons involved in the trial or who have a legal and ethical obligation to access it. You should also be informed of how your data will be stored, used and disposed of after the trial is over.
You have the right to know about the institutional ethics committee and its role in protecting your rights, safety and wellbeing as a research participant.
If there are any irregularities, or you have concerns or complaints about a trial you're involved with, you can contact the ethics committee. Your concerns will be dealt with promptly and confidentially.
What are the risks and benefits of being in a trial?
The main risks of clinical trials are:
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The treatment you receive may turn out to be ineffective
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Possible side effects from the medication, from minor and unpleasant to serious complications requiring medical attention
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Being required to alter or abstain from the treatment that you were receiving prior to the trial
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Time and inconvenience associated with frequent trips to clinics, hospital stays, additional medical tests and procedures
The main benefits of a clinical trial are:
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The opportunity to play an active role in your own healthcare
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Gaining access to new treatments that are not available to the general public
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Obtaining expert clinical care at a leading research centre
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Additional care/tests specific to the trial
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Helping others in the future by contributing to science
What is the role of the ethics committee?
All clinical trials must be reviewed and approved by the institutional ethics committee before they begin. The role of the ethics committee is to ensure that risks for clinical trial participants are responsibly managed and that the risk to benefit ratio is as favourable as possible. The members of an ethics committee come from a range of backgrounds and their viewpoints and life experiences can provide very important insights into how trials can be safely conducted in the best interests of participants.
Ethics committee review will include an assessment of whether the proposed trial is feasible, whether participants are fully informed about the benefits and risks related to the trial, and whether the healthcare professionals running the trial are competent to protect participants from harm. Once a clinical trial has commenced, the ethics committee has the authority to modify to stop the trial at any time based on the data.
What are the facilities like at Sydney Clinical Trials?
We will do our utmost to make you feel comfortable and welcome at Sydney Clinical Trials. Our facility is bright and recently renovated with comfortable resting chairs and entertainment facilities including television with streaming services. We can also provide meal deliveries from the café downstairs.
What trials does Sydney Clinical Trials run?
Sydney Clinical Trials specifically runs gastroenterology trials in all phases (1-4) of clinical development.