What are clinical trials and are they right for me?

Healthy participants are paid for their time, but that’s rarely the sole reason for someone becoming a participant. It’s also about doing something for the greater good – it’s about supporting medical research that will help change and even save lives, maybe even the life of someone they know who will benefit from the development of a new therapy or drug.

Others join us as patients. Usually, these 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 trial is different, but generally, you will receive timely instructions from us regarding your admission to our clinical trial centre in Perth. We will give you information as to what you need to bring and what we provide such as our facilities and food. 

The safety and security of our team and participants is our priority, so on arrival your bag will be searched and you’ll undergo some standard tests, which may include screening for recreational drugs and an alcohol breath test.

With the admission process complete, you’ll be escorted to your assigned bed, with lockable drawers and a personal locker for your belongings.

During your stay, you’ll have several tests, including blood sampling, ECG measurements (traces of your heart rhythm) and blood pressure, and you will, of course, receive a dose of the study drug or a placebo.

All your study requirements will be outlined in your information sheet and consent form, including details about the length of your study (studies can range from a few clinic appointments to one-month in-clinic duration stay).

When you apply for a trial, we collect the information you provide and store it securely in accordance with our Privacy Policy. Any general personal information we collect may be viewed by members of the pharmaceutical company sponsoring the trial (the sponsor), the Human Research Ethics Committee who approved the trial, and government regulatory agencies (including the Australian Therapeutic Goods Administration).

Moreover, throughout your trial our medical officers and staff will collect and record a range of medical information relating to your health, but this data can only be accessed by Linear personnel.

When the clinical trial results are reported in a formal document to the trial’s sponsor, you will only be identified through a clinical trial identification number. When the study is complete, your information is archived and only Linear personnel have access to your personal information.

Please note, when you arrive for each visit to our clinic, you’ll be asked to provide photo ID (eg. a driver’s licence, passport, proof of ID card) to verify your identity.

Informed consent means that you can make a decision about participating with an understanding of the trial and what it involves. We need your informed consent before you can become a participant. Our Informed Consent Form (ICF) contains detailed information about the study and treatment, and you must read it before deciding whether or not to take part in the trial.

The ICF includes explanations about what the trial involves, the duration of the study, the frequency and length of the required visits, as well as any known risks and benefits associated with the study treatment. Crucially, to ensure your safety you must abide by all study restrictions that are outlined in the ICF.

Participation in any clinical trial is completely voluntary, and you’re free to ask questions about the trial – you should only consent to participate in the study (by signing the ICF) once you’re completely happy to do so. As a volunteer, you also have the right to refuse participation in a trial or to withdraw your consent at any time during the study, without penalty.

Your wellbeing and best interests are our primary concern, so if new information becomes available during the course of the trial – information that may affect your decision to continue with the trial – we will share the information with you as soon as possible.

Please note, our physicians can decide to withdraw a participant at any time, without the participant’s consent, if it becomes clear that it is not in the participant’s best interest to continue with the trial.

Most clinical trials are sponsored by pharmaceutical companies, but they can be sponsored by other organisations or individuals, such as medical foundations, medical centres, universities and physicians. Physicians often sponsor clinical trials that evaluate whether a currently available therapy (that’s used for the treatment of one condition) can be used for the treatment of a different condition or disease.

Clinical trials typically progress through several phases:

Phase I: Tests safety and dosage in a small group of healthy volunteers or patients.
Phase II: Evaluates effectiveness and further assesses safety in a larger group.
Phase III: Confirms effectiveness, monitors side effects, and compares the treatment with standard options.
Phase IV: Occurs after approval to be taken by the public, monitor long-term safety and effectiveness in the general population​