Frequently Asked Questions - Participants
Anyone can apply to participate in a clinical trial, however, you will need to meet certain eligibility criteria (requirements) to qualify for study participation. This will be discussed with you over the phone before attending our site and during your first visit.
Clinical trials provide an opportunity to try a new treatment and contribute to important medical research that may lead to effective new treatments for others like you. You may or may not benefit from participating in a clinical trial. Possible benefits are discussed in this article. You can discuss the clinical trial with your GP, specialist, family, and friends before making a decision.
All medical procedures and research studies come with potential risks. It is possible that you will experience side effects to the study treatment, or the treatment may not work for you, or you may receive a placebo. (Not all clinical trials use a placebo). The possible risks will be listed in the Participant Information Sheet that you receive before deciding to participate in a trial.
Participant safety is of the utmost importance. Many measures are put in place to protect clinical trial participants.
Clinical trials involving new treatments must follow strict laws, regulations, and ethical guidelines. Before any clinical trial can start, the study must be approved by a human research ethics committee. The committee will include health professionals, researchers, lawyers, a minister of religion or elder, and lay members of the community. They will review the study and may request changes to ensure that the rights, safety, and wellbeing of the study participants will be protected. The committee will continue to monitor the study and require us to submit regular updates. They can terminate the trial if there are serious safety concerns or evidence of misconduct.
Applying For a Clinical Trial
If we think you may be suitable for the trial based on the study requirements, we will call you to discuss the trial and ask more questions to see if you qualify for a screening visit. If you qualify, we will send you a copy of the Participant Information Sheet and Consent Form for you to read and book you in for a screening visit at our site.
Read more about the screening process here.
At the screening visit, you will meet with the study doctor and coordinator to discuss whether the trial is right for you. You are encouraged to ask questions.
You will be asked to sign an informed consent form before providing any information, or completing any study assessments or tests required to determine if you are eligible to participate in the trial.
To determine if you are eligible to participate in the trial, you will be asked questions about your health and medical history. Screening may also involve completing health questionnaires, a physical examination, ECG, vital signs, blood tests, medical imaging, such as x-ray, MRI, or scans, or other assessments. You will be asked to sign an informed consent form before completing any study assessments or tests.
If you are eligible to join the trial, you will be booked in for a baseline visit. Read more about the screening process here.
Every trial has a set of requirements for participation known as eligibility criteria. The criteria can be very strict. This is to ensure that you will not be exposed to any potential unnecessary risks, especially if the trial is likely to be of little to no benefit to you.
Attending Our Study Site
We are located at 220 Denison Street, Broadmeadow, NSW (view on Google maps).
We have free, onsite parking reserved for our participants at the front of our building. Parking along the street is also free, however, please be aware that some areas have a 2-hour parking limit.
Our office is a short walk from Broadmeadow train station, and a 30-minute drive from Newcastle Airport.
Please bring a form of ID. It is a good idea to bring a copy of your medical history, including current and past medications and previous surgeries or procedures, to your first visit. Please also bring a copy of your banking details so that we may reimburse you for your travel and time as a study participant.
Participating in a Clinical Trial
This depends on the trial and will be explained in the Participant Information Sheet provided to you. If you have provided informed consent and met all the eligibility criteria at the screening visit, you are eligible to participate. You will then be booked in for a baseline visit. Baseline assessments and tests will be conducted before you receive the study treatment.
You will return to the site for follow-up visits, which may involve more health questionnaires, medical tests, and/or other assessments. The visit schedule will be outlined in your Participant Information Sheet.
For more information, read this article.
Our friendly staff are listed on our About Us You will be looked after by our front desk staff when you arrive. When you are ready to be seen, the trial coordinator will greet you and take you to one of our clinical rooms. The study doctor (also known as an Investigator) will meet you there.
For some studies, such as vaccine studies, the treatment may be given by a research nurse.
For a medical device trial, such as a spinal cord stimulator study, you will see a device technician (also known as a field clinical engineer, or a programmer). They will activate your device and change the settings to optimise the therapy for you.
Other healthcare professionals that you may see as part of a study include research assistants, psychologists, medical imaging staff, and hospital staff (for trials involving surgery or advanced procedures).
The length of a clinical trial will depend on the type of study, the treatment, and the trial phase (learn about phases here). Many of the trials that we conduct involve several months of participation. Some trials can last several years. Long trials often involve only one or two site visits per year after the first year or two.
The duration of a study and the number of study visits will be detailed in the study Participant Information Sheet.
You may be reimbursed for your time and travel expenses as a study participant. Any study procedures, equipment, and/or medical care related to your trial participation may be provided at no cost to you. Details will be provided in the study Participant Information Sheet.
You might need to stop certain medications before you can participate in a clinical trial, however, this should always be done under consultation with your doctor. Some trials require you to stay on a stable dose of your current medications during the study. Specific requirements will be outlined in the Participant Information Sheet and explained to you by the study doctor.
You must tell the study doctor or coordinator if there are any changes to your medications during your participation in the study.
Your study coordinator will be your main contact. To speak with them, please call 02 4985 1860.
If you need to talk to your study doctor between visits, we may be able to arrange a phone call. If you have any concerns, please call us on 02 4985 1860. We will notify the study doctor and book you in for an unscheduled visit if needed.
You are free to withdraw from a trial at any time. You do not need to give a reason, and your decision will not affect your ongoing medical care. For safety reasons, you may need to follow some instructions to stop the study treatment. If you have any ongoing problems or side effects, we will follow-up with you until they have been resolved or your condition is stable.
Once all participants have attended their last follow-up visit and all data has been collected, the data will be analysed, and a final study report will be written. The report will not have any information that can identify you. A summary of the results may be published in a medical journal. The whole process can take several months. You may or may not be notified of the trial results.
For more information about what happens after a trial, read this article.
You should report any side effects or changes to your health, including minor or non-serious problems, to your study doctor or coordinator. Please call us on 02 4985 1860 if you have any concerns and need to see the study doctor before your next study visit.
If you are experiencing serious side effects or changes to your health, please call us so that we may book you in for a visit as soon as possible.
During the study, you will be given a contact card with an afterhours mobile phone number. In case of an emergency, please call this number to talk with a study coordinator. For any non-urgent matters, please call our office number on 02 4985 1860 during work hours.
You are free to withdraw from the trial at any time, however, you should talk to the study doctor before stopping a study treatment. They will advise you on how to safely stop the treatment.
For studies involving implanted medical devices, we can arrange for you to have the device surgically removed (explanted).
Whether or not you can continue taking a study drug or keep a medical device after a trial will be explained in the Participant Information Sheet provided to you. If the treatment has not yet been approved for use in Australia, you might not be able to access it after the trial. However, your doctor may be able to apply for special access to prescribe unapproved goods. You should discuss your options with your study doctor.
A placebo is a treatment that has no active properties. An example is a sugar pill that looks the same as the study drug. Not all clinical trials involve a placebo. Comparing the study treatment to a placebo allows researchers to see if the study treatment has any real effects. Participants are usually not told if they will receive placebo or study treatment.
Ask us a question
Can’t find the answer to your question? Fill out the contact form below or call us on 02 4985 1860.