FAQs for participants on general clinical trial information, and assistance towards trial registration.
What reimbursements can I get for participating in a clinical trial?
Each clinical trial is different, and reimbursements for participating in clinical trials varies depending on several factors, including the trial schedule and time commitment. Some trials may offer specific monetary reimbursements for your time and participation, and some trials may offer other forms of reimbursements such as out-of-pocket expenses such as travel, parking and meals.
The specific reimbursement details are provided in the participant informed consent form provided at the trial site by the study team.
What is a clinical trial?
Clinical trials are an essential part of developing new treatments. A clinical trial can help researchers investigate a potential new treatment, diagnostic test, device to evaluate the safety and effectiveness of new medical treatments, interventions, or procedures.
Clinical trials in Australia must comply with the Therapeutic Goods Administration (TGA) regulations, the National Health and Medical Research Council (NHMRC) guidelines, and the Australian Clinical Trial Handbook. These regulations ensure that the trials are conducted with the highest standards of safety, quality, and ethics.
Before commencing, all clinical trials must obtain approval from an independent Human Research Ethics Committee. Ethical approval is a critical step in the process of conducting clinical trials to ensure that research involving human participants is conducted ethically, with responsibility and with due consideration of participant safety, welfare and rights.
How do I know what I am committing to?
Once you register interest for a clinical trial with Evrima, you will be required to complete a series of steps which include Pre-Screening, Screening and Outcome.
- Pre-Screening — you will be required to complete a pre-screening survey and/or a phone call. The phone call will outline the study requirements, including the trial schedule, investigational treatment and location of the study site conducting the research.
- Screening — if it appears that the trial may be suitable to you, you will be referred to the study site where you will receive more detailed information and an informed consent form. You will have the chance to discuss the trial with the study doctor, ask any questions you may have, and consult your own GP (if desired) before signing the consent form.
- Outcome — should the study site conclude you are eligible to proceed with participation in the clinical trial, you will be enrolled onto the study, and your treatment periods will commence as scheduled with the study site.
How many phases of a clinical trial are there?
There are typically four main phases of a clinical trial plus the 'Preclinical' stage which refers to cell and animal studies. You will be informed of which phase your chosen clinical trial is prior to committing.
- Phase I studies focus on evaluating safety and how the drug interacts with the human body.
- Phase II studies focus on evaluating safety, side effects, measures effectiveness and dosage.
- Phase III studies confirm effectiveness and monitor safety.
- Phase IV studies are conducted after a drug has been approved to gather information on side effects in long term use.
Why should I consider participating in a clinical trial?
By participating in a clinical trial you are contributing to the progress of medical knowledge, helping enhance potential new treatments for various conditions and potentially gaining access to new therapies or interventions before they are widely available. Eligible participants are also provided access to study-related medical care at no cost.
What if I want to withdraw from a clinical trial?
You have the right to withdraw from a clinical trial at any time. Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage. Your decision will be respected and will not affect your future medical care.
Can I participate in more than one clinical trial at a time?
All clinical trials adhere to strict study protocols, and each study will specify if it's feasible to be in more than one study at a time. Participants should read the study details carefully, consult their healthcare professional, or speak with the Evrima Patient Experience team if they have any further questions before deciding to register for a clinical trial.
