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General Clinical Trial Information

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What is a clinical trial?

A clinical trial is a research investigation in which people volunteer to test new treatments or interventions to determine their safety and effectiveness at preventing or treating disease. Clinical trials may look at how people respond to a new treatment, compare existing treatments or may look at other changes that affect their health (such as dietary changes).

Clinical trials are essential to determine whether new treatments are effective and safe. Most modern medical interventions are a direct result of clinical research and require trials.

All our clinical trials have been approved by the Ethics Committee of the Royal Victorian Eye and Ear Hospital.

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Why be part of a clinical trial?

By taking part in a clinical trial, you can contribute to the advancement of scientific knowledge and, in some cases, improve health for yourself or others with the same disease or condition. Clinical trials can also provide access to new interventions before they are widely available.

Australia conducts internationally recognised high-quality clinical trials. Australian clinical researchers have a wealth of knowledge and expertise that is helping to improve health care both in Australia and around the world. Clinical research also improves our health care service by improving patient care practices.

As a participant, even when you receive the highest quality care, you may also benefit from additional support and attention provided by clinical trial staff who understand your disease or condition.

What are the potential benefits and risks of participating in a clinical trial?

Participating in a clinical trial can have both benefits and risks.

The benefits may include:

  • The opportunity to be given a new intervention that may be better for your condition with fewer side effects than the treatment you are receiving now. Trials may offer participants access to the newest interventions before they are made available to the public.
  • The chance to play an active role in your own health care and gain a greater understanding of your disease or condition.
  • Advice, care and support from trained clinical staff who understand your disease or condition.
  • Closer monitoring of your condition, care and treatment.
  • Clinical trials may also be valuable for people with rare or difficult-to-treat conditions where there is limited evidence about how the condition is best treated or managed.

Please note: There is no guarantee any individual participant will receive any direct benefit from taking part in a trial.

Some possible risks of participation in a clinical trial include:

  • The new intervention in the clinical trial may not work for you.
  • The new intervention may not be as effective as established interventions or standard care.
  • There may be unpleasant, serious or even life-threatening side-effects associated with the new intervention.
  • The need for additional treatment, tests, hospital visits or complicated medication requirements arising out of your participation in the trial. For example, you may need to keep a symptom diary, collect 24-hour urine specimens or wear a monitor overnight.
  • Depending on the type and phase of the trial, unanticipated risks due to limited use or testing of the intervention in humans.
  • Some clinical trials may require a major commitment and may involve discomfort or pain.

The risks of a specific trial are described in detail in the participant information and consent form which will be provided to you prior to your decision to participate in a trial.

What is the process if I decide to participate in a clinical trial?

Before participating in a clinical trial, a study doctor and a study coordinator will discuss the trial with you in detail and will also give you a written participant information and consent form. You cannot be entered into a trial if you do not want to be.

If you wish to participate in the trial, a screening visit will be booked for you. At this visit you will speak to a study coordinator and a study doctor who will discuss the study. You will be asked to sign a consent form after all of your questions have been answered and you agree to proceed.

At this first visit you will undergo various tests to determine your suitability. Clinical trials have strict guidelines as to who is suitable to be included in the trial, this is based on the presentation of your condition and any other health problems you may have. You must also be able to attend the required appointments, which may be more frequent or of longer duration than if you were not in a clinical trial.

If there are any changes to the trial or to the protocol, you will be kept informed and you may be asked to give your consent again before proceeding with the trial.

At each appointment you will usually be seen and tested by an orthoptist involved in your trial before seeing one of the study doctors. The tests performed will vary, depending on the trial.

When the trial finishes the study doctor will refer you to either a clinic within the Royal Victorian Eye and Ear Hospital or a private ophthalmologist for ongoing management.

What happens if I change my mind about participating?

Participation in a trial is voluntary, and participants are free to leave a trial at any time. However, treatment you receive on the trial may not be continued outside the trial and your treatment will revert to the routine “standard of care”. You should discuss your decision to leave the trial with your doctor as there may be additional follow-up required. Your decision to withdraw at any stage will not result in any penalty or loss of any rights or benefits to which you are otherwise entitled. Your doctor will inform you about information about you that has been collected for the trial.

What questions should I ask before entering a clinical trial?

You can download a list of questions to ask before entering a clinical trial here: Australian Clinical Trials Questions to Ask.

Where can I find more information about clinical trials?

For more general information about clinical trials you may wish to:

How do I get involved?

If you are interested in partaking in a trial at CERA you could become involved in several ways:

  • If you have an eye condition that we study, then discuss your potential involvement with your current eye health care professional. He/She can find more information on the specifics of the trials and how to refer to us in the Health Care Practitioner section of this site.
  • If you have an eye condition which is not currently being studied, or you are currently not suitable for a trial, you can register on our ‘Web Sight’ with all of your details and we may be in touch if a suitable trial comes up.
  • You may wish to make a monetary donation to the Clinical Trial Research Centre so we can continue our sight-saving work.
  • You can also contact the clinical trials team directly at the email address: cera-trials@unimelb.edu.au.
  • If you are currently participating in a clinical trial, you can direct questions to the study coordinator or lead ophthalmologist (principal investigator) at any time.

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