Respiratory Clinical Trials – Eastern Clinical Research Unit

You may be asked to participate in a clinical trial, it could be to:

• Complete questionnaires
• To take new medication
• To have tests such as CT scans, lung function tests, 6 minute walk tests, blood tests, ECG tests
• Additional clinic visits with our doctors
• Follow-up phone calls with our research staff

In participating in the research, the clinical trial will be fully explained to you prior to your decision and  you may be asked to sign a consent form. Participation is voluntary and you can withdraw at any time without it affecting your normal care or treatment

Not everyone who participates in a research study will personally benefit. Your participation may benefit the community by helping researchers to learn more about a certain disease or condition, a new treatment or a better way to provide care or services.

However, in some studies, you may personally benefit, such as a survey. Any potential risk or benefit of participating in a research project will be fully explained to you before you commence. The Human Research Ethics Committee ensures that research is ethically sound and as safe for participants as it can possibly be, before it is approved.

More information on how to get involved.

If you or someone you know has a known diagnosis of a respiratory disease, discuss your eligibility for our trials with your doctor. For more information contact our team on ecru.respiratoryreferrals@monash.edu.

For general information about clinical trials visit the Australian Clinical Trials website or see the Consumer Guide to Clinical Trials.

Contact Us

Respiratory Trials Team Leader

Emma Jackson

P: +61 400 722 153

E: ecru.respiratoryreferrals@monash.edu

We currently have trials available for:

• Severe Asthma
• Idiopathic Pulmonary Fibrosis
• Progressive Pulmonary Fibrosis
• Chronic Obstructive Pulmonary Disease
• AATD Emphysema
• Chronic Spontaneous Urticaria

To refer your patient to our trial’s unit, please send their contact details to the email below. Attach a referral letter stating the patient’s clinical diagnosis and any other supporting documents (eg. CT scans, Spirometry).

P: +61 400 722 153

E: ecru.respiratoryreferrals@monash.edu

1. Who can participate in a trial?

Anyone can participate in a trial, however, eligibility for each trial will be different. Our current respiratory trials only include individuals with a known diagnosis of COPD, IPF, PPF, Severe Asthma and AATD Emphysema. Our current allergy trials only include individuals with a known diagnosis of Chronic Spontaneous Urticaria. Our screening process will assess each eligibility criteria for a study to determine if you can begin on a trial.

2. Can I participate if travel is an issue for me?

Yes. Location is not an issue and we can reimburse you for any expenses incurred such as travel, accommodation and food. Get in touch with our team for further details.

3. Am I guaranteed a place in a trial?

No. Our trials have specific criteria to be eligible for a trial. We assess your eligibility for specific trials firstly during a pre-screen phone call and then secondly during screening visits where you are required to attend our site to undergo pathology, imaging, lung function tests, 6 minute walk tests and ECG tests. This will determine whether or not you can progress onto a study.

4. How long do I need to commit to a trial for?

All of our trials vary in timeline. In the past our trials have varied from 8 weeks to 3 years. If you begin on a trial and wish to no longer take part, you may withdraw your participation at any time.

5. What happens if I experience a side effect to a drug?

We will provide you with our contact details to inform us of ANY medical issues that arise during your participation. We ask you to report all medical incidents even if you believe it is unrelated. Our doctors monitor all side effects and communicate with your GP and other clinicians involved to assess your health. You may be asked to visit our site for an extra assessment by a doctor. Our clinicians will then make an informed decision about whether to have you continue on the medication.

6. How do I register my interest in participating in a clinical trial?

Send us an email with your expression of interest and contact details and someone from our research team will get in touch with you.

7. What will my participation look like?

1. Contact + pre-screen: Your participation will involve an initial phone call from one of our staff members to complete a pre-screen checklist to see which trials you will be eligible for and to detect any obvious issues/concerns that may immediately exclude you from screening for any particular trial. Before any study-related procedures are done you will be sent a participant information consent form to read and ask any questions you may have.
2. Screening period: If you agree to participate you will sign the consent form. Your study doctor will also inform your GP and/or specialist that you are participating in the research study. During the screening period, you will have various assessments and tests so that the study doctor can find out if you are eligible for the study. This may involve testing such as pathology testing, ECGs, CT scans, spirometry, and 6 minute walk tests. The screening period is different for each study; however, you will be advised of this before you attend our site.
3. Treatment period: If you are eligible to take part in the study after you complete the Screening Period, and you decide to continue, you will enter the treatment period of the study. This period includes taking the medication, attending visits for testing and completing questionnaires. We will monitor you during this time period and any adverse reactions must be reported.