VOLUNTEERS

After your study eligibility has been determined by a study doctor you may then commence participation in the study.

Participation can involve regular visits to our Clinic at designated time intervals for the duration of the study.

Most studies involve either regularly taking an active drug or a placebo. Most trials are ‘double blind’, meaning neither you, or the nurses, know whether you are receiving the active drug or not. This is done to make sure that the real drug is effective. After a period, lots of trials that have had positive results become ‘open-label’ which means everyone who was previously taking a placebo will receive the active drug.

A clinical trial can run anywhere from one month to three years but a typical length is 12 months.

Study visits will take approximately 2 – 3 hours each and you will be asked to remain at the clinic during the study visit.

Procedures can include regular lung function tests, ECG’s, vital signs measurements, physical examinations, blood tests and urine tests. Some studies require you to have a chest x-ray or CT scan.

Each trial is designed to meet a specific set of research criteria. Each study enrols patients with certain conditions and symptoms that can include:

• age
• gender
• medical history
• current health
• disease severity
• ability to comply with the study protocol.

If you fit the guidelines for a trial, you may be able to participate. In some instances, you may be required to undergo certain tests before being accepted.

Although there are possible risks with any treatment, there are also many benefits from participating in a trial, including:

• You have access to promising new treatments that are only available in clinical research trials.
• If the treatment being studied is more effective than the standard treatment, you may be among the first to benefit.
• Regular health checks by health professionals mean you have more personalised and regular care, and most of our patients report an increase in the management of their conditions and better wellbeing as a result of their increased healthcare.
• Results from the study may help others in the future.

All clinical trials have risks, because any medical test, drug or procedure has risks. Patients will be informed of any known side effects they could experience, as well as any side effects that occur, or become known while they are participating in the trial.

The risk may be greater in a clinical trial because some aspects of any new treatment are unknown. In our trials, we assess all patients for suitability for the trial, and if we feel that participation in the trial may endanger your health, then you would be advised not to enrol. Close monitoring is the hallmark of all clinical trials and allows any adverse effects of the treatment or unexpected deterioration in health to be detected early and steps taken to end treatment or give additional care. The new treatment may not be better than, or even as good as, the standard treatment.  If you are in a randomised trial, you will not be able to choose if you are getting the new treatment, the standard approach or a placebo.

Each clinical trial is designed differently:

• Some trials compare one treatment to another.
• Some compare active treatments to a placebo.

To note: clinical trials on people with lung disease must also be designed to allow participants to use medication to relieve their symptoms, so that receiving a placebo will not endanger your health.

Unfortunately, neither you nor the doctor can choose which treatment you get on a trial.

All your personal and medical information will be kept confidential. Our healthcare team needs your personal and medical information to give you the best possible ongoing medical care. This is how your information will be utilised and kept confidential:

• You are assigned a number or code to keep your information confidential — your name is not on any forms or in the study database.
• Your medical information such as past medical history, current medications and test results are put on special forms and into secure computer databases. This data is then analysed to extract the study outcomes.
• The study sponsor will access this information for audit purposes to ensure the data is of good quality and the study has been conducted according to the extensive research guidelines. On rare occasions the Therapeutics Goods Administration (TGA) and the Food and Drug Administration (FDA) or study sponsor may access this information for audit purposes to ensure the data is of good quality and the study has been conducted according to the extensive research guidelines. All your personal information is de-identified and is never used in any published study results too.

Yes. A patient can leave a clinical trial at any time and for any reason.

• You can ring our friendly staff on (08) 6151 0888 or email admin@resphealth.uwa.edu.au, or complete the online form, and let them know you’d like to be considered for a trial.
• Answer some questions to be put on our database, so we can contact you when the trial or any future trials are ready to recruit.
• If you are suitable for the trial, we will send information about what is involved and an appointment will be made for you to come in and meet the nurses.
• At your meeting (depending on the trial) you will undergo some tests, for example breathing tests and completing questionnaires.

You can also sign up to our e-newsletter and check our website for news of upcoming trials.

To find out if a trial is suitable for you or for more information contact our Clinical Trials Team on (08) 6151 0888 or email admin@resphealth.uwa.edu.au.