What is a Clinical Trial?
Clinical trials are research studies designed to test new treatments, devices or diagnostic tools that researchers hope will improve outcomes for patients. There are many different types of clinical trial. Some are interventional – for example, asking a patient to take a new experimental drug that researchers hope will potentially have fewer side effects or prolong life compared to existing treatments. Others may be observational, seeking to collect information about how patients respond to other elements of treatment – for example, looking to see whether increased exercise or changes in diet can assist with the management of a particular disease.
Interventional clinical trials will typically follow a structured process that involves four phases of activity and subsequent review.
Clinical trials are highly regulated, with the principle aim of ensuring that the rights, safety and well-being of trial participants are protected.
In Australia, clinical trials are governed by the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and the NHMRC Australian Code for Responsible Conduct of Research. Clinical Trials involving unapproved drugs or devices are also regulated by the Therapeutic Goods Administration (TGA) who have adopted the international standard for clinical research activities, referred to as ICH-GCP or Good Clinical Practice.
All clinical trials within Ramsay Health Care are conducted by an experienced team that involves medical professionals, nurses, allied health staff and a dedicated clinical trial coordinator. This team of health professionals is there to ensure that all clinical trial activities are run to a high standard, in compliance with the national codes of conduct and, most importantly, to monitor the care of the people enrolled on the trial.
Further information about clinical trials and how they work in Australia can be found from Clinical Trials Australia.
Why Participate in a Clinical Trial?
Participation in a clinical trial is voluntary. If you choose not to participate in a clinical trial, it will not affect your standard treatment or your relationships with the health professionals involved in your care.
Clinical trials can lead to the development of new treatments which can take 5-15 years to before they are approved on the market. As a result, participation in a clinical trial may give you the opportunity to access potential new treatments before they reach the market, and provide you with an alternative treatment option to the standard treatments.
Clinical trials are crucial to progress as they provide researchers with much needed evidence that a new treatment works in a way that is anticipated. They can help to demonstrate that patient outcomes improve, and assess whether the benefits associated with the new treatment outweigh the risks. Unfortunately, there is only so much testing that can be done in the laboratory and, at this point in time, there are no artificial systems that replicate the human body and the effectiveness of new treatments so clinical trial testing is imperative.
Clinical trials also help to improve health care services by raising standards of treatment. Doctors and hospital staff involved in clinical trials are continually trained to provide best practice patient care. Australian clinical trials are internationally recognised as providing very high quality patient care.
Benefits and Risks
It is important to recognise that there are both potential risks and potential benefits associated with participating in a clinical trial.
Potential benefits of being part of a clinical trial include:
- Close monitoring of your condition by a highly qualified team of medical and clinical staff.
- Access to alternative treatment options that may be more suitable for you not yet available outside studies
- Contribute to advance knowledge in health and medicine
- Increase treatment options
- Potential for personal treatment benefit
However, there are always other things that need to be considered before enrolling in a trial:
Potential side effects – As the clinical trial is testing new treatments or devices, there may be side effects that are not anticipated or known at the time of enrolment. You should speak to your doctor about known potential side effects before you enrol.
Time & Commitment - To ensure that sufficient data is collected about the new treatment, a rigorous schedule must be followed that may require more tests or visits over a longer period of time than if you did not participate in the trial. Whilst you should not have any out of pocket expenses as a result of participating in the trial, you should always speak to your doctor about the schedule of treatment and make sure you are comfortable with it before enrolling.
No guarantee – Clinical trials seek to understand if the experimental treatment, device or diagnostic tool offers an improved treatment option for patients. However, this is an experimental activity and there is no guarantee that it will be better than the standard therapy.
Placebo-controlled trials - Some clinical trials have two treatment options, one of which looks the same as the experimental treatment but does not contain any active ingredient (i.e. a placebo treatment, which does not have any real effect). These types of trials will randomly select patients to either treatment option and, as a result, there is a chance that the treatment you receive is not the experimental treatment. However, you will still always receive an effective treatment if there is one that is suitable.
Before you participate in a clinical trial, you will be given a patient information and consent sheet. This information sheet has all of the information about the trial and goes into the detail about the potential side effects and the treatment schedule. If you are considering being a part of a clinical trial, you should review this information sheet carefully before consenting to participate in the trial activity.
How to Enrol in a Clinical Trial
To be referred to a clinical trial within Ramsay Health Care, your GP will need to write a letter of referral to the Lead Investigator of the clinical trial.
Once you have obtained a letter of referral, please contact the trial coordinator at the site, who will help you to arrange an appointment where the lead investigator will meet you and then discuss your eligibility for the trial.
There are over 80 clinical trials that are open for recruitment within Ramsay Health Care at any point in time. A list of trials can be found on the ClinTrial Refer app or australianclinicaltrials.gov.au.