About Clinical Trials

1. What is an investigator-led clinical trial?

2. Why should I participate in an investigator-led clinical trial?

3. What are the advantages and disadvantages of participating?

4. How do I find and join an investigator-led trial?

5. Where can I find more information?

1. What is an investigator-led clinical trial?

An investigator-led clinical trial is a study designed by clinicians/ researchers to test the safety, acceptability and effectiveness of drugs, devices, procedures or other therapies in human participants before they become available to the public.

Investigator-led clinical trials are an important part of our health system as they are about real people fighting disease and being able to access the most effective medical treatment. Clinical trials are the only way that new treatments can be approved for human use. Trials are also important in improving the diagnosis of disease and patients’ quality of life.

In thoracic cancer research, investigator-led clinical trials can answer questions about how to:

• determine any genetic predisposition to cancer
• detect cancer at an early and treatable stage, for example using screening tests, scans or other special tests
• diagnose cancer, for example using screening tests, scans or new technologies
• treat cancer, for example using surgery, drugs and radiotherapy or different combinations of treatment
• manage symptoms of cancer or its treatment, for example using drugs and complementary therapies such as diet and physical exercise

2. Why should I participate in an investigator-led clinical trial?

Trials look at new ways to prevent, detect, or treat disease. Without clinical trials, drug and medical device manufacturers are unable to bring promising new treatments to the people who need them. Investigator-led clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

The goal of an investigator-led clinical trial is to determine if a new test or treatment works and is safe. Treatments might be drugs already approved for use but in different combinations, or new surgical procedures or devices. These trials can also look at other aspects of care, such as improving quality of life for people with cancer.

People with an illness or disease participate in investigator-led clinical trials not only to help others, but also to potentially receive the newest treatment, as well as to have the additional care and attention from clinical trial staff. Patients are taking an increasingly active role in managing their health and, as partners in research, your participation is invaluable.

3. What are the advantages and disadvantages of participating?

Advantages include:

  • Playing an active role in your treatment
  • Access to new or different combination treatments that are not available to the general public, which may be more effective
  • Obtaining the research treatment at no cost during the trial
  • Close follow-up and medical care at leading institutions
  • Contributing to the development of future life-saving or life-enhancing treatments
  • Helping others who are diagnosed with the same condition in the future

Disadvantages include:

  • The possibility of unexpected side effects from the research treatment
  • The research treatment may not be more effective than the standard treatment, or may not work
  • If the trial involves a comparison between two or more groups, you may be in a control group that, depending on the specific trial design, receives the standard treatment, a placebo or no treatment rather than the research treatment
  • More frequent visits to the hospital or doctor’s rooms

4. How do I find and join an investigator-led clinical trial?

For anyone interested in being part of an investigator-led clinical trial, the first step is finding out more about which trials are available to participate in and what is involved.

Each trial has specific eligibility criteria as not all patients can participate in the trial, depending on the research question and treatments involved. Eligibility criteria help ensure that patients in a trial are similar to each other in terms of factors such as age, type and stage of cancer, general health and previous treatment. When all trial participants meet the same eligibility criteria, it gives researchers greater confidence that the results of the trial are due to the treatment being tested and not other factors.

It is a good idea to seek out information from a number of sources. For example, your GP or specialist may be able to advise you of trials that might be suitable for you; the Australian New Zealand Clinical Trials Registry (ANZCTR) is a searchable registry of trials in Australia and New Zealand; and the US National Institutes of Health website ClinicalTrials.gov provides information about trials that are recruiting in the US (and frequently in other countries). For you to be recruited to a trial, you need to talk to your specialist who will be able to refer you if you meet the eligibility requirements.

5. Where can I find more information?

If you would like to learn more about investigator-led clinical trials visit the Australian Cancer Trials website which has been developed by Cancer Australia in partnership with the Australian New Zealand Clinical Trials Registry (ANZCTR), the University of Sydney and Cancer Voices. It has been designed to provide Australians with consumer-friendly information about current cancer clinical trials.

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