Everyone has their own reasons for choosing to participate in clinical trial research.
Some join us as paid volunteer participants. As the name suggests, volunteers get paid for participating in our clinical trials, but that’s often not the sole reason for someone registering to become a participant.
Often registration is motivated by participating in projects that will help change and even save lives, and in many cases it is the life of someone they know who will benefit from the development of a new therapy or drug.
Others may join us as patients. In this case, the participants are people who are undergoing treatment for a condition or disease and they’ve reached a stage where it’s time to explore new options, which can include being the first to try the next generation of therapies or drugs.
Every clinical trial is different some trials are short, some are longer. Some trials require participants to stay on site, others require scheduled check-in visits.
On arrival, you'll be greeted by CMAX staff and your ID will be checked against a photo ID which you must bring to check-in. You’ll undergo some standard tests, which may include screening for recreational drugs and an alcohol breath test. We will also ask to check your belongings to ensure you have not packed food or drugs that may interfere with the trial you have volunteered to undertake. Your health and well-being are of the utmost importance to us, and all of these procedures help us to ensure that you are trial-ready.
Once the admission process is complete, you’ll be given a tour of the clinic including our recreational area and you will be escorted to your assigned area and shown a personal locker for your belongings
During your stay, you'll receive a dose of the study drug and you’ll have several other monitoring tests, including (but not limited to) blood sampling, ECG measurements (traces of your heart rhythm) and vital sign measurements (body temperature, pulse, blood pressure).
All your individual study requirements will be outlined in your information sheet and consent form, including details about the length of your study. Participants are entitled to cease participation in a trial at any time.
Participation in any clinical trial is completely voluntary and you consent to participate in the study by signing an Informed Consent Form (ICF) once you’re completely happy to do so.
Our Informed Consent Form (ICF) contains information about the study and treatment, and you must read it before deciding whether or not to participate in the trial. Information includes explanations about what the trial involves; things like the duration of the study, the length of the required visits, as well as any known risks and benefits associated with the study treatment to assist you in your choice.
Your health and well-being are important to us, so if any new information becomes available to us during the course of the trial – information that might alter your consent – we'll share and discuss the information with you for your peace of mind.
As a volunteer, you have the right to refuse participation in a trial or withdraw your consent at any time during the study, without penalty. Also, please note, our medical staff can withdraw a participant at any time if it becomes clear that it is not in the participant’s best interest to continue on with the trial.
Clinical trial participants are, most often, eligible for reimbursement for their time and their local travel expenses. Payment amounts vary and are not intended to cover a loss of earnings or risk associated with your participation.
Please note that payments are made without any tax deduction, as in almost all cases study participation is not deemed as taxable income. A person participating in numerous clinical trials in a single tax year should seek their own personalised tax advice on whether this might be classified as a commercial activity by the Australian Taxation Office (ATO).
If you’re unable to complete a clinical trial with us, you may be eligible to receive a partial payment, based on your length of participation. This will be determined by the Principal Investigator and is dependent on the circumstances for the withdrawal.
In Australia, clinical trials are legally required to be approved by an ethics committee (Human Research Ethics Committee) which comprises of seasoned medical professionals, as well as community and lay people who together sanction the safety of the clinical trial.
Health risks and side effects are pre-determined during pre-clinical and early clinical studies, but side effects can differ from person to person and there is no way to 100% predict how a treatment will affect an individual. This is why early phase clinical trials involve many rigorous safety assessments during their conduct.
Your daily meals and bed linen will be provided during your stay, as well as wireless internet access.
We have a communal PlayStation, TV, and DVD player in our recreation room. You are also welcome to bring cards, board games, books, magazines, personal computers to entertain you throughout our stay.
When you come to CMAX for a trial that requires sleeping over. Please bring along:
- Photo ID
- light clothes
- enclosed footwear (you must always wear these in the clinic).
You are also welcome to bring cards, board games, books, magazines, computers etc for your entertainment.
Clinical trials sponsors are most often pharmaceutical companies, but sponsors can also be organisations or individuals, such as medical foundations, medical centres and universities.
It is not uncommon for doctors to sponsor clinical trials in an effort to evaluate whether an available therapy can also be used for the treatment of a different condition or disease.
General personal information collected may be viewed by members of the sponsor (the company sponsoring the trial), the Human Research Ethics Committee who approved the trial, and government regulatory agencies reviewing the trial (including the Australian Therapeutic Goods Administration (TGA)).
When the clinical trial’s results are reported to the trial’s sponsor, you will be identified only by a clinical trial identification number. When the study is complete, your information is archived and only CMAX personnel have access to your personal information.
Clinical Trials require study monitors, (people working on behalf of the trial sponsor).
The monitors will access your source data at the study site or remotely and will be (where applicable) provided direct electronic access to copies of your source data to be able to review this information remotely via a verified secure electronic platform that meets Australian and international standards for data protection.