Clinical trials research the effects of one or more health-related treatments on health outcomes.
If you would like to learn more about clinical trials, the Australian Clinical Trials website provides more information: Australian Clinical Trials – For Consumers.
We are thankful to our patients who choose to take part in clinical trials. They make this research possible and help to improve healthcare for the community.
What is a clinical trial?
Clinical trials are voluntary. People may participate willingly in these trials for several reasons. These trials include testing new treatments, interventions, or tests, to help prevent, detect, or manage different diseases or medical conditions.
Some trials look at how people respond to a new intervention and what side effects might occur. This helps researchers to decide if a new treatment works, if it is safe, and if it is better than other treatments that are already available.
Clinical trials might also compare existing treatments, test new ways to use or combine other treatments. Clinical trials usually observe how people respond to other factors that might affect their health.
Researchers may also conduct clinical trials to check diagnostic or screening tests and new ways to detect and treat disease.
Phases of clinical trials
Many clinical trials that develop new treatments take place in phases. In the early phases, researchers give the new treatment to a small number of participants to assess safety and how well it works. If the treatment is promising, it may move to later phases of testing. At this phase the number of participants increases to collect more information on the treatment.
Why do we need clinical trials?
Clinical trials are essential to develop new treatments. Most modern medical treatments are a direct result of research. New treatments for most diseases and conditions have been developed through research. Clinical trials often lead to new treatments becoming available that help people to live longer with less pain or disability. Clinical trials also lead to improvements in quality of life.
Clinical trials can also help to improve health care services.
Why participate in a clinical trial?
The discovery of new treatments can help people to live longer, be in less pain or free of poor health or disability through research. Healthy participants and those with a health condition or disease help to find new ways to prevent, diagnose, treat, and potentially cure diseases or health conditions. By taking part in a clinical trial, you can contribute to improved health for yourself and others.
If you are healthy or free of the health condition or disease related to the clinical trial, you may choose to take part to help others.
By volunteering you may help improve the lives of family, friends or others. Volunteers should think carefully about participation. You should consider the demands on your time and the risks and benefits (if any) of the trial.
You may decide to take part if you have the disease or health condition related to a clinical trial. You could also decide to do this because you want to contribute to a better understanding, treatment or potential cure for this condition.
In some cases, your participation can provide access to new treatments before they are available. Clinical trials may also offer the hope of developing better treatments or tests for a particular disease or condition. So even if a trial does not directly provide benefit to the participant, it may provide benefits for others in the future.
FAQs – Participating in a clinical trial
Are there any risks associated with participation in clinical trials?
There may be some risks when participating in clinical research. It's important to read all the information carefully and ask questions so that you understand the risks involved.
New drugs, devices or procedures are tested by researchers in a non-clinical setting first and may have been tested on animals. Some side effects may be known, while others may not. Each person may react differently to a medication or procedure.
You may need to come off your usual medication, for example, to test the effectiveness of a new medication tried. There could be risks with this choice, and it's important to discuss this with the researcher. You should know the benefit and risks when choosing to participate.
You will be told by researchers of all known risks in writing, provided in a document called a Participant Information and Consent Form (PICF). The researchers will give this to you before you decide to take part in any research. They'll answer any questions that you may have. It's possible you will experience side effects not previously reported during clinical trials. The research team monitor the safety of participants and will provide emergency contact details.
Are there any costs involved with participating?
Sometimes research will take part during your routine care and may not involve extra visits or services.
Generally, clinical trials are sponsored by government agencies, universities, medical centres, pharmaceutical companies, and device manufacturers. Where they are sponsored, there should be no cost to you.
It's important to discuss these considerations with the researcher when you are invited to take part.
What about time off work to attend study appointments?
If your involvement in a research study requires you to take time off work, you can request a medical certificate from the research team.
How do I know that the research is ethical and approved by the Hospital?
In all cases, research must be approved by a nationally certified Human Research Ethics Committee (HREC). The research must be approved by the hospital before starting a study or engaging participants.
Before enrolling in any clinical trial, you'll receive a written information sheet which contains details about the study. You must sign a consent form, which has been approved by the ethics committee.
If you have any concerns about the conduct of the study at any time, you can speak with - the Chair of the Human Research Ethics Committee or the local Research Governance Officer at the hospital. The names of all the people you can contact including the study doctors will be listed on the study information sheet.
How do I participate in a clinical trial?
If you would like to be a part of a clinical trial, the first step is finding out more about trials in general. A good starting point is the Australian Clinical Trials website. It's a good idea to seek out information from different sources. There is a wealth of information available on this and other websites about clinical trials.
Once you have found or been approached by a researcher about a clinical trial, it's important to find out what will be involved. At Darling Downs Health, we encourage you to ask questions, and seek the information that you need to make an informed decision.
You may talk to any of the health professionals involved in your care.
Everyone who participates in a clinical trial must give ‘informed consent’ or have a parent or guardian or other legally authorised person give consent.
This means that potential participants are given information about the key facts of a trial before deciding whether to take part. Informed consent also means that participants are provided with information on new developments throughout the trial.
You cannot be entered into a trial if you don’t want to be. If you are asked by a researcher to take part, you are free to say yes or no at any time. There should be no pressure on you to enter a trial.
To help you decide whether to be part of a trial, a member of the research team will explain the details of the trial to you. The researchers will also give you a document, usually called a Participant Information and Consent Form (PICF). This document includes key details about the study such as its purpose and duration. You can ask anything that is not clear to you or that you don't understand. You can take time and talk it over with family and friends or your own doctor before deciding whether to take part.
You will then be able to decide whether you would like to take part. If you do sign the consent document and decide to take part, this means that you are agreeing to participate in the trial. It also means you have understood what it will involve. The consent document is not a contract, and you may still withdraw from the trial at any time. If you do withdraw from a clinical trial, the relationship between you and your doctor will not be affected. You will still receive the best treatment that Darling Downs Health can provide.
If there are any changes to the trial or the protocol, you'll be informed, and you may be asked to give your consent again before proceeding with the trial.
Information for our Industry Partners
Why conduct a clinical trial at Darling Downs Health?
Darling Downs Health has many advantages as a place to conduct clinical trials. The Australian Government has invested $125 million to improve the health of Australians in rural, remote and regional areas through access to innovative clinical trials.
It's through the research done in these clinical trials that people gain access to better treatments. We aim to put our researchers at the forefront of global research and give more patients more treatment options regardless of where they live.
International standards of conduct for clinical trials, developed by the International Conference on Harmonisation (ICH) and the International Organisation for Standardisation (ISO), provide a benchmark on clinical research quality that can be relied upon throughout the world. Under the Therapeutic Good Act 1989 and associated regulations, ICH or ISO Good Clinical Practice (GCP) standards are mandatory for all Australian clinical trials involving unapproved medicines or medical devices. Many Australian researchers have international experience and are familiar with GCP and other guidelines.
Australia adheres to the highest level of GCP standards, meaning that Australian clinical data and results are accepted by international regulatory agencies, including the United States Food and Drug Administration and the European Medicines Agency.
The Australian Therapeutic Good Administration (TGA) has adopted the European Guideline CPMP/ICH/135/95 (and therefore the ICH E6 guidance) in principle, with some elements modified according to local regulatory requirements.
International and Australian research sponsors
International and Australian research sponsors can develop and support the highest quality clinical trials and benefit from the advantages of the Australian clinical trials environment.
Efficient ethics and regulatory framework
Australia has a fast and pragmatic regulatory pathway for clinical trials. Under the Clinical Trials Notification (CTN) scheme, research proposals are submitted directly to certified Human Research Ethics Committees (HRECs) which assume the primary review responsibility for ethical and scientific review.
Darling Downs Health HREC operates under the National Mutual Acceptance Scheme. Darling Downs Health is certified to review clinical trials - Phase III, clinical trials - Phase IV and clinical trials – devices.
Darling Downs Health has adopted the streamlined ethical clearance process for multi-centre research. This process helps to reduce unnecessary duplication of review of research.
Diverse participant recruitment pool and healthcare environment
Darling Downs Health has an informed and willing population of potential trial participants. We operate in a multi-cultural region with a diverse population that is capable of meeting recruitment needs.
Darling Downs Health clinical practices and some aspects of our health care system are similar to the United States, the United Kingdom and most of Europe.
Government commitment to clinical trials
The Australian Government is committed to improving the clinical trials environment in Australia.
More details on the initiatives that will improve the clinical trials environment, along with their progress can be viewed online at the Australian Government Clinical Trials webpage.
Contact our clinical trials team
Those interested in participating in clinical trials at Darling Downs Health should contact DDHHS-ClinicalTrials@health.qld.gov.au to register their interest.
Alternatively, patients are encouraged to speak with their treating practitioner in relation to clinical trials which may be available.