What is a Clinical Trial?

A clinical trial is a medical research study that aims to find a better way to treat a particular disease or fix a medical problem. During the trial, the therapy or drug being tested is given to a group of volunteers. Information is then collected by doctors and nurses on how well the treatment worked. Data is also collected on side effects. Doctors use the results from clinical trials to decide which treatments are best for patients like you.

Why do I have to sign a consent form to participate in a trial?
Informed consent is one of the most important parts of the trial process. It is important that when you volunteer, you are given all of the information you need to make up your mind whether you want to take part. It is you right to ask as many questions as you want of you doctor or nurse until you are sure you understand what the trial involves. You can also take the information sheet home and discuss it with a family member or friend before you agree to take part. By signing the consent form, you are confirming that you have been given the form and that you understand this information. You should not sign the form unless you understand what you are being asked to do.

All clinical trials are required to be reviewed and approved by an Ethics Committee. The Ethics Committee is an independent group of medical, scientific and legal experts, as well as lay members of the community, who decide if the trial is safe and fair to trial participants. The information sheet you will receive will have the contact details of the Ethics Committee who approved that trial. If something about the trial troubles you and you wish to discuss it with a person not directly involved in the trial, the Ethics Committee can be contacted.

If you choose not to participate in a clinical trial, you will not be treated any differently by your doctor or nurse. It is you body and your health, and you should not feel pressured to do anything you are not comfortable with.

Are there any benefits in participating in a clinical trial?
There are several potential benefits to participating in research:

  • By being provided with access to information about the trial, you may gain a greater understanding of your disease, and the possible treatments for it
  • By participating in a research trial, you are able to play an active role in your health care
  • If you participate in a clinical trial, you may be given access to treatments or tests that are not available to the general public
  • You may be followed up more closely if you are a trial volunteer, which might mean more or longer clinic visits, or more in-depth tests at those visits
  • Other patients in the future may benefit from the knowledge gained during the clinical trial

Where can I get more information about trials in general?
The Australian government website ‘Australian Clinical Trials’ provides more information on clinical trials, including a list of questions you might want to ask before you volunteer to take part www.australianclinicaltrials.gov.au/consumers.

What is the difference between an investigator-led and industry-led trial?
An investigator-led trial is one that is developed by a clinician or researcher whereas an industry-led trial is one that is primarily run by the pharmaceutical industry. Due to the high cost of running a clinical trial, most are industry-led.

In order to support clinicians and researchers and help them develop and run high quality, investigator-led trials, The Australian Clinical Trials Alliance (ACTA) was established. They stress the importance of having investigator-initatiated or “public good” clinical trials as they address important gaps in our knowledge.

How do I know if I’m right for a clinical trial?
Information on all AKTN clinical trials can be found in the Trials section of this website. The trials select people with specific diseases, with certain symptoms, on specific modes of renal replacement therapy, and on specific medications. Talk to your doctor or nurse about which trials you might be able to be a part of. If there are no AKTN clinical trials that are suitable for you at your clinic, there might be a locally run trial that you can be a part of. Not all patients with kidney disease will be suitable for participating in trials.

How do I sign up?
The first thing to do is talk to your treating doctor or nurse. They will be able to tell you which trials are being run at your clinic or hospital, and which you are suitable for. If there is a trial that you are suitable for, they will guide you through the information and consent process.

For more information about our recruiting trials, please visit Trials in Development.