Trial safety
Thinking of contributing to human breakthroughs in WA and have a few questions? Our answers to the most frequently asked questions are set out below.
Have further questions? Please call us on 1300 546 327 or email contactus@linear.org.au we’ll be happy to help!
Question List
What are the risks associated with a clinical trial? Are clinical trials safe?
New treatments undergo extensive testing before they can be tested in clinical trials, and each trial requires approval by an independent, government-registered ethics committee.
While we do everything in our power to eliminate risk, there may be risks associated with participating in a clinical trial. Every effort is made to determine any risks during pre-clinical and early clinical studies, but there may be side effects and other health risks that we are unable to anticipate, mainly because side effects can differ from person to person. All our participants are monitored by our team of clinical and medical professionals while on a trial, and the principal study doctor for each trial can be contacted at any time if required.
In short, you’ll have the very best clinical and medical professionals looking after you, but there is no way to predict with 100% certainty how a treatment will affect any given individual.
Any risk associated with a study will be discussed with our doctors during the screening process.
What level of insurance do you have for adverse events?
While severe adverse events are extremely rare and every precaution is taken to avoid this outcome, each trial at Linear is covered by insurance for these events. While we do have insurance, adverse events are very rare and we run our clinical trials to the highest ethical and safety standards. This means that all of our participants can feel confident when they volunteer with Linear.
If you want more information about our insurance for adverse events, please get in touch with us via our Contact Us page so that we can address your concerns in more detail.
I want to volunteer, but I'm worried about safety
We can let you know that every trial at Linear requires approval by an independent ethics committee – registered with the Australian Government’s National Health and Medical Research Council (NHMRC). Linear follows regulations and guidelines in accordance with international certification under Good Clinical Practice (GCP) and in accordance with TGA (Australia), FDA (USA), EMA (EU) and Medicines Australia guidelines.
If you did choose to apply for a trial, you would go through a rigorous screening process, which includes an in-depth discussion with a doctor who explains exactly what you can expect from the trial. While participating in the study, you are monitored by our team of clinical and medical professionals, to ensure your health and safety.
If you would like to find out more about the safety of our clinical trials, you can watch a video explaining the safety of trials, below:
If you have any further questions, you can get in touch with our friendly Participant Experience Team via our Contact Us page.