Find out about clinical trials.
For anyone participating in a clinical trial, knowledge is both empowering and reassuring. We provide all the information and answers you need before, during and after the clinical trial. That's because we recognise and appreciate the conviction that goes into your decision and your vital contribution to the work that researchers couldn't do without you!
As the patient, you are at the heart of any clinical study – your rights and protection are a top priority. We want to make sure that all patients fully learn and understand their rights before any trial, so that they can expect their rights to be honoured during the trial.
You have the right to understand all aspects of the clinical trial, including any possible risks and benefits of participating. The informed consent process makes sure the benefits and risks are clear to you and provided in a printed document for reference.
Become familiar with the consent form
If you decide to participate in a trial, you'll be asked to read and sign the consent form to confirm that the trial has been explained to you and that you have agreed to participate.
Learn about potential risks
It's important to us that you feel at ease asking members of the research team as many questions as you need, any time, to feel fully reassured and informed.
You are absolutely entitled to ask questions about:
You also will have access to direct contact with a trial representative and a person from the Ethics Committee. You should always feel that the trial process is transparent and that the research team is approachable and open to giving you any answers and reassurance you need.
Personal health information from your original medical records and all data resulting from your participation is collected in the trial. Your personal health information could include physical examination details, any blood test results, X-rays, other medical procedures or tissue sample testing. Your identity is always protected through a numbering system. Your name and contact details will never be disclosed, unless required by law.
Who sees your data
Information from the trial is submitted to the sponsor , to the
Your personal information – kept private and confidential – will be held separately in a secure location at all times. The only people with access to your personal health information in identifiable form will be:
You have the right to request to see your records from the trial investigator or the facility where the study was conducted. However, you may not be able to review or make a copy of your records until after the study has been completed.
Clinical trial data are highly confidential until the results are published in a medical or scientific journal. Before then, only selected research staff, sponsor, review board and regulatory individuals are allowed to see the trial data. Sharing data with any other person before completion can compromise the validity of the study in its entirety and jeopardise patient confidentiality and privacy. The trial doctor will let you know what information they can and cannot share with you before the trial is officially over.
Participation in a clinical trial is completely voluntary, so you have the right to withdraw from the clinical trial at any time, for any reason.
If you do stop your participation for any reason, you will continue to receive care and advice on your treatment options. You will be asked to return for a final evaluation by the trial doctor, which may include a physical examination and/or laboratory tests.
When you participate in a clinical trial, your health status is closely monitored by the highly qualified, specialised clinical trial doctors who care for you.
The doctor is responsible for providing you with top medical care throughout the study and ensuring the same level of medical care and follow-up for an appropriate period after the trial, depending on the protocol.
Even if you stop the trial early, the doctor will honour the same trial patient-physician relationship and continue your care for an adequate period.
However, a clinical trial doctor does not replace the healthcare professionals you see in your day-to-day life.
Ideally, with your permission, clinical trial doctors and your usual healthcare team collaborate to avoid repetition of tests and ensure that you get the best possible care during the trial.
Every participant in a trial, from the sponsor to you – the patient – has responsibilities to fulfil. Here's an introduction to the key players and each one's role and expectations.
A clinical trial simply wouldn't be possible without the participation of patients. Each patient's full and diligent participation directly affects the accuracy of the study's findings, so patients play a key role in a study's success.
What are a patient's responsibilities?
Tasks vary depending on the trial, but here are some simple steps that can make the process more rewarding for both you and the team following your progress:
What is a trial sponsor?
The organisation or person(s) that funds, undertakes and supervises a clinical trial.
Who can be a sponsor?
What are the sponsor's responsibilities in a clinical trial?
The (TGA) requires that sponsors of most clinical trials (i.e. for trials in phase 1, 2, or 3) submit information documents regarding the objectives, goals and procedures of the clinical trial, as well as information to support the quality of the medication. The TGA then reviews the application for approval or denial.
The sponsor also:
What is a clinical research coordinator?
The study coordinator allows doctors to meet all their clinical trial responsibilities by handling the day-to-day logistics and reporting of the trial. Often a certified nurse, the study coordinator is also a great resource for the trial participants.
What are the study coordinator’s responsibilities?
Study coordinators are often involved in the informed consent process and ensuring compliance with the protocol. The coordinator plays a significant role in the trial's success by ensuring that trial visits, tests and procedures are scheduled on time and that patients understand how to take the study drug and complete the trial questionnaires or diaries.
The study coordinator's additional responsibilities include:
The hands-on leader of a clinical trial at the research site, the investigator – or trial doctor – is in charge of the conduct of the trial in their hospital/clinic, with a specific focus on patient protection and scientific validity of the trial data.
Who is the principal investigator?
A doctor who is fully qualified to practice medicine and to run clinical trials. All principal investigators are:
Clinical trials sometimes take place in multiple locations or countries. In these cases, each location has its own principal investigator for the research site.
What are the principal investigator's responsibilities?
While the principal investigator is personally responsible for all aspects of the trial, he or she supervises a team of professionals who all contribute to patient safety and compliance with Good Clinical Practices. In particular, the principal investigator: