A Clinical Trials a research study that explores whether a new medicine, treatment or device is safe and effective for humans. Most modern medical processes and products are a direct result of clinical research. Before any new medicine, treatment or device can be approved for use in Australia, it must undergo a clinical trial.
These studies help determine which medicines, treatments or devices work best for certain illnesses or groups of people, and can also be used to help improve healthcare services by raising standards of treatment.
For an overview, download The Consumer Guide to Clinical Trials.
In Australia, clinical trials are governed by national ethics guidelines and codes of conduct which are listed in the National Statement on Ethical Conduct in Human Research and the Australian Code for Responsible Conduct of Research.
At Scientia Clinical Research, all of our clinical trials are carried out under the strict supervision of qualified doctors, nurses and other research professionals. Every clinical trial is evaluated and approved by an independent Human Research Ethics Committee (HREC) and acknowledged by the Therapeutic Goods Administration (TGA) before the trial can go ahead.
All clinical trials have guidelines about who can participate, known as inclusion and exclusion criteria. Inclusion Criteria must be met before you can be accepted into a clinical trial, while meeting one or more Exclusion Criteria will rule you out.
We recruit volunteers between the ages of 18 and 65 who aren’t taking any medications and are in good health. Healthy volunteers are classified as having no medical problems and who aren’t taking medications on a daily basis. This is important because it allows us to study how a drug is absorbed and excreted by the body without other medications interfering. Patient clinical trials typically include people with a specific medical condition.
Just like every clinical trial is different, so too are the possible risks and side effects. When registering your interest in a clinical trial, you will receive a study-specific Participant Information and Consent Form (PICF) that contains all available information. Before participating in a trial, you will also undergo a thorough medical examination that includes blood tests, tracing your heart rhythm and measuring your blood pressure, because with Scientia Clinical Research your safety always comes first.
If you are eligible to participate in a healthy volunteer clinical trial, you will be compensated for the time you spend with us. This amount is typically calculated based on the amount of time involved and the number of times you have to visit the clinic. Payment for taking part in a patient clinical trial is dependent on different factors. Reimbursement information will be communicated when you first speak to us, and can also be found in the Participant Information and Consent Form (PICF).
While your personal information will remain confidential, the study results are typically published in scientific journals or trial websites once all clinical phases of a trial are complete.
The Scientia Clinical Research website hosts a wealth of information about clinical trials, including why someone might want to take part, the ethics and regulation of clinical trials in Australia and how to find a trial that is relevant to you. Australian Clinical Trials and NSW Health & Medical Research are two alternate sources of information.
If you are interested in participating in a clinical trial, you should consult your general practitioner (GP) to determine if this is the right decision for you. They will help you find a suitable trial and make sure you understand what’s expected before you agree to participate. You can register for a clinical trial with Scientia Clinical Research here.