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Clinical Trials

What is a clinical trial?

 

Clinical trials are research studies that explore whether a new treatment, is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people

 

Why are clinical trials needed?


Clinical trials are necessary to show that a new treatment is safe and effective for use in humans. Clinical trials help confirm if the treatment being studied will work, what the side effects are, how well they are tolerated and what the correct dose of a medicine should be. This helps doctors to decide if the new treatment is more effective and/or safer than existing medicines or treatments.  A clinical trial is commenced only after results of testing in the laboratory, animals or previous clinical trials has been completed with positive results.

Without clinical trials, new medicines cannot be approved for use in Australia.  The many treatments we now have for cancer patients are only approved and available because of the generous participation of countless previous patients in clinical trials.

How are clinical trials approved?

 

Clinical trials must be ethically and scientifically reviewed by a Human Research Ethics Committee (HREC) before commencing.  The HREC is a group of doctors, nurses, researchers, lawyers, ministers of religion and male and female members of the public.

Once a clinical trial is approved by a central ethics committee it will then be submitted to the Research Governance Office for approval before the trial can commence at Ballarat Health Services.

 

Who runs a clinical trial?


Each clinical trial at the BRICC is led by a cancer specialist who is referred to as the "Principal Investigator". The clinical trial team includes doctors and nurses, pharmacists and other health care professionals. The clinical trial team is responsible for the safe conduct of the whole trial. 

 

What are the benefits from participation in a clinical trial?


There are a number of possible advantages of participating in clinical trials. These may include:

  • Contributing to the development of future life-saving or life-enhancing treatments. You can help future generations of patients with the same condition early access to new medicines not otherwise available;
  • obtaining the clinical trial medicine at no cost, during the trial;
  • receiving close monitoring of your health

Risks of participation

There are risks, however, to clinical trials:

  • Side effects from the trial treatment or procedures.
  • The experimental treatment may not be effective
  • You may need additional tests and procedures which are trial-specific.
  • You may need to visit the hospital more frequently and/or stay in hospital longer for monitoring of your condition.
Details of risks related to participation in the clinical study are spelled out in the consent form participants sign when they agree to participate.

 

How can a person participate in a clinical trial?


The clinical trial protocol for each study specifically explains who can and cannot participate in a clinical trial. There are specific conditions or criteria that are part of the protocol that a person must meet in order to be considered eligible for participation. These inclusion and exclusion criteria are designed to help protect the safety of those participating and to help insure that the research question being studied is able to be answered as efficiently as possible.

If you are interested in participating in a clinical trial speak to your GP or specialist looking after you.

 

What should I do or ask when I meet the study physician or research coordinator
  • What exactly is the purpose of the study?
  • Who is eligible to participate in this study?
  • Why does the study physician believe the new medicine, device, or treatment may be beneficial or effective?
  • How many people have been enrolled in the study nationwide or internationally?
  • How many people have been enrolled in the study by the study physician?
  • What tests, procedures, and medications are involved in the study?
  • What are the alternatives to participating in the study?
  • What are the possible benefits to participation in the study?
  • What are the possible risks and discomforts involved by participating and how do they compare to the alternatives to participating?
  • How might participation and the experimental treatment affect my daily life?
  • How long will my participation in the study last?
  • Will any of the tests or procedures involve being hospitalized?
  • Which tests, procedures, or services involved in the trial will not be billed to me or my insurance?
  • Will I be reimbursed or paid in any way for my participation?
  • How might I know if the medication or treatment is working in any way?
  • Will the results of the study be made known to me at any point?
  • Will I be told which treatment group I was assigned to?
  • Who will be in charge of my care?
  • Who should I contact or go to if I experience any unexpected effects or complications?
  • Who do I notify if I decide to leave the study?

Before making this important decision you will be given a full plain-language explanation of the clinical trial, in writing and verbally.  You should ask any questions that you wish to and carefully consider all the information before deciding to participate.  You may wish to discuss the trial with your family or local doctor before making your decision. Remember, participating in any research is voluntary.  You will receive appropriate care for your illness whether or not you choose to participate.

 

What happens if side effects occur from taking a drug in a clinical trial?


By the time a drug is ready to be tested in a clinical trial it has already been extensively tested for likely side effects. However it is not possible to know all its side effects until it is used in humans.  There may be additional unforeseen side effects. If these occur, appropriate medical care will be provided to participants.

 

What about my privacy?


All clinical trials are conducted in accordance with the Victorian Health Record's Act Privacy Principles.  Therefore your information will be kept confidential and you will not be able to be identified in any publication of the results. Your consent to share your information with any other organisation will be obtained before information is released.

Further Information

Further information about clinical trials can be obtained from:

  • National Health & Medical Research Council

www.australianclinicaltrials.gov.au

www.nhmrc.gov.au/


  • Medicines Australia
www.medicinesaustralia.com.au

  • Therapeutic Goods Administration

www.tga.gov.au/

 

  • Research Australia

www.researchaustralia.com.au

 

Acknowledgements

  • Melbourne Health ethics