About Clinical Trials

The National Clinical Trials Governance Framework defines clinical trials as any research study that prospectively assigns people or groups of people to one or more health-related interventions to measure the effects on health. Clinical trials research aims to prevent, diagnose, and treat illnesses, to benefit all people across diverse backgrounds. In Australia, before a new drug treatment is approved, the government requires data from clinical trials that shows a new treatment is safe and effective. This data is assessed by the Australian Government’s Therapeutic Goods Administration (TGA) before new medicines are approved for prescribing by your doctor or hospital and made available for sale at the pharmacist. Clinical trials are carefully designed, reviewed, and need to be approved by a Human Research Ethics Committee before they can start. People of all ages can take part in clinical trials, including children.  

People volunteer to take part in clinical trials to test medical interventions including drugs, vaccines, devices, health services, health education and preventative strategies.  

There are different types of clinical trials. 

Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from recurring. Prevention trials may investigate medicines, vitamins, vaccines, minerals, or lifestyle changes. 

Screening trials test new ways for detecting diseases or health conditions. 

Diagnostic trials study or compare improved methods for diagnosing specific disorders or conditions. 

Treatment trials test new treatments such as new medications or combinations of medications, new psychotherapies, new devices, new approaches to surgery, or radiation therapy. In this type of trials researchers assess the safety, safe dosage ranges, side effects and effectiveness of these new treatments. 

Behavioural trials evaluate or compare ways to promote behavioural changes designed to improve health. 

Quality of life trials (or supportive care trials) measure ways to improve the comfort and quality of life of people with conditions or chronic illnesses.  

Genetic Studies aim to improve disorder prediction by understanding how genes and illnesses are related. They can also be used to develop personalized treatments based on a patient’s genetic makeup. 

Epidemiological Studies are used to identify patterns, causes, and control of disorders in groups of people. They often involve large-scale data collection, statistical analysis, and observational studies. Examples include cohort studies, case-control studies, and cross-sectional surveys. 

What are the Phases of a Clinical Trial? 

Clinical trials are conducted in a series of progressive steps called “Phases”. There are typically 4 Phases and each phase is designed to answer specifics question about the treatment.  

• Phase I studies usually test new drugs for the first time in a small group of people to work-out a safe dosage range and identify side effects. Phase 1 is firstly usually in healthy participants. 
• Phase II studies test treatments that have been found to be safe in Phase I but now need a larger group of people to monitor for efficacy and any adverse effects. 
• Phase III studies are conducted on larger populations to confirm effectiveness, monitor side effects, compare to existing treatments, and collect safety information in different regions and countries. These trials provide data for a new treatment to be assessed by the TGA when considering an application for approval. 
• Phase IV studies take place after the treatment has been approved by the TGA and there is a need for more testing in a wide population over a longer timeframe. 

Clinical Trials are Regulated 

In Australia, clinical trials are conducted following rigorous guidelines and regulations to ensure participant safety, scientific integrity, and ethical standards.  

Before a trial can start it needs to be reviewed and approved by an independent Human Research Ethics Committee (HREC) according to the National Statement on Ethical Conduct in Human Research 2023 | NHMRC.  All HRECs must register with the National Health and Medical Research Council (NHMRC) and adhere to the NHMRC guidelines. 

Here at Eastern Health the Eastern Health Human Research Ethics Committee (HREC) and Subcommittee are responsible for providing ethical and scientific review of research projects and serve to protect the welfare of research participants. More information about Eastern Health’s HREC committee can be found here. 

Researchers must submit their trial protocols to HRECs for ethical evaluation before proceeding with the study. The HREC will assess the trial’s ethical aspects, such as ensuring the informed consent procedures are robust, evaluating potential benefits against risks, protecting participant’s privacy and confidentiality, ensuring fair recruitment and treatment and assessing the trial’s scientific merit. 

Running Clinical Trials  

The clinical trial team is a collaboration of various professionals and it includes doctors, nurses and other healthcare professionals. The clinical trial team is responsible for the conduct of the trial, and this may include checking the health of the participants at the beginning of the trial, monitoring them during the trial, and staying in touch with them for a period of time after the clinical trial has been completed. 

The key team members of a clinical trial include: 

Principal Investigator (PI): The Principal Investigator is usually a doctor, but can also be nurse or other professional researchers. They lead the trial, oversee all aspects, and ensure compliance with protocols. 

Trial Coordinators: Nurses or research assistants who manage day-to-day operations, participant recruitment, and data collection. 

Associate Investigators: Both medical and non-medical practitioners involved in patient care and data collection. 

Pharmacists: Responsible for drug management, dispensing, and safety. 

Other Healthcare Professionals: Pathologists, radiologists, allied health, and other professionals contribute as needed. 

Who funds Clinical Trials? 

In Australia, clinical trials can receive funding from various sources. The Australian Government has a number of programs to support clinical trial research including The Clinical Trials Activity initiative and NHMRC grants. Universities and Research Institutions can contribute to clinical trial funding through internal grants or collaborating with external partners. Non-profit organisations and foundations, for example the Cancer Council, support clinical research by funding grants, scholarships, and donations to advance medical knowledge. Pharmaceutical companies, biotech firms, and other companies often sponsor clinical trials. Healthcare organisations may also support clinical trials if other funding is not available. 

When participating in a clinical trial in Australia, you have important rights that are designed to protect your wellbeing and ensure ethical conduct. Your rights include: 

Informed Consent: Informed consent is crucial. Before joining a trial, you must receive detailed information about the purpose of the trial, potential risks and benefits, procedures involved, your right to withdraw at any time, confidentiality, and contact details for queries. You can take your time to decide whether to participate and ask any questions about the trial. 

Ethical Approval: All clinical trials must undergo ethics review by a Human Research Ethics Committee (HREC). The HREC ensures that the trial adheres to ethical guidelines and operates transparently. The informed consent form will have information about the reviewing HREC.  

Privacy and Confidentiality: Your privacy is protected. Researchers must handle your personal information confidentially. Data collected during the trial should be anonymized whenever possible. 

Right to Withdraw: You have the right to withdraw from the trial at any stage without penalty. If you decide to withdraw, it won’t affect your future medical care. 

Safety Monitoring: Trials are closely monitored for safety. You’ll be informed of any new risks or findings during the trial. 

Access to Information: You’re entitled to receive information about the trial results once it concludes. 

Compensation and Insurance: Compensation for any harm resulting from trial participation should be discussed. In Australia, all clinical trials must have appropriate insurance coverage. 

Most importantly your participation is voluntary, and your rights are paramount.  

More Information 

The Australian Charter of Healthcare Rights describes rights that you, or someone that you care for, can expect when receiving healthcare. These rights apply to all people in all places where healthcare is provided in Australia. The Australian Charter of Healthcare Rights is for everyone. The Charter is available in 19 languages and can be found here.  

Australian Clinical Trials is a government initiative that provides information and resources to participants about taking part in, accessing clinical trials. There is a helpful Consumer Guide to Clinical Trials with information about clinical trials that can be downloaded. Click here to read the consumer guide. 

Participating in a clinical trial is a voluntary decision. There are both risks and benefits when participating in a clinical trial. It’s important to discuss the potential benefits and risks with your doctor and ask questions before deciding to participate. The types of questions you may want ask if you are considering joining a clinical trial can be found here. 

The potential benefits of participating in a clinical trial include: 

Access to New Interventions: Participants may receive new interventions before they are widely available to the general public.  

Improved Treatments: Clinical trials test new medicines, devices, and interventions. By participating, you contribute to finding better treatments and increasing medical knowledge. 

Active Role in HealthCare: By joining a trial, you actively engage in your own healthcare and gain a deeper understanding of your disease or condition. 

Extra Support: Clinical trial staff provide specialized care and support, and they understand your specific disease or condition. 

The potential risks of participating in a clinical trial include: 

Discomfort or Pain: Some trials involve discomfort, pain, or invasive procedures. It’s important to consider these potential downsides against the benefits. 

Time Commitment: Clinical trials can require significant time and effort. Participants must attend regular appointments, follow protocols, and complete assessments. 

Side Effects: New interventions may have side effects or adverse reactions. Researchers closely monitor participants for any unexpected effects. 

Uncertainty: There is no guarantee that you will directly benefit from the trial. Some participants may receive placebos or standard treatments. 

Privacy Concerns: Sharing personal health information during a trial may raise privacy concerns. 

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The following general information is provided for people who may be considering participating in a clinical trial. It may not be applicable to all clinical trials as trials can be structured differently from one another.   

People may experience the same disease differently. It’s essential that clinical trials include people from culturally and linguistically diverse backgrounds, as well as characteristics like age, sex, and sexual orientation, so that all communities benefit from scientific advances. 

Many different types of people can take part in clinical trials. Some are healthy, while others may have illnesses. Who can participate in a clinical trial will depend on the type of study. 

Researchers follow the clinical trials protocol when deciding who can participate in a study. These guidelines are called Inclusion/Exclusion Criteria. Inclusion criteria refer to factors that allow individuals to participate in a clinical trial, while exclusion criteria are factors that prevent participation. These criteria are based on things such as age, gender, the type and stage of a disease, treatment history, and other medical conditions. Before joining a clinical trial, participants provide information to help the research team assess their suitability for participation. 

Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Inclusion and exclusion criteria are not meant to personally reject individuals, rather they are used to identify appropriate participants and keep them safe. 

There are a number of steps that need to be taken when becoming a clinical trial participant. 

First you will need to let your doctor or healthcare provider know that you are interested in participating in a clinical trial. You can also find trials through here (link to EH page “Interested in Participating in Clinical Trials”).  

Once you have found a suitable trial you will answer preliminary questions online or during an initial phone call to assess your potential eligibility. 

If you meet the initial criteria, the research team will schedule a screening visit. During this visit the trial staff will discuss the trial in detail, assess your health, medical history, and eligibility. During this visit you will learn the trial’s purpose, procedures, risks, and benefits. 

If you meet the inclusion criteria and wish to participate in the clinical trial you will then be given an informed consent form. This document outlines the trial’s objectives, procedures involved, potential risks and benefits and rights as a participant. It is important to take time to read and understand the form thoroughly and ask questions if you are unsure of anything. By signing the consent form it indicates you are voluntarily agreeing to participate. 

If you qualify, the trial team will perform baseline assessments. These assessments establish your health status before the trial begins. 

Some trials involve random assignment to different study groups (e.g., treatment group vs. control group). Randomisation ensures unbiased allocation. In some trials you may not know which group you’re in (blinding). 

Once enrolled, it is important to follow the trial protocol by attending scheduled visits, receive the assigned intervention, follow instructions (e.g., dietary restrictions, exercise routines) and report any changes in your health or adverse reactions quickly. 

During the trial the research team will monitor your progress through regular visits and assessments. Follow-up visits can occur after the trial ends to evaluate long-term effects. 

You have the right to withdraw from the trial at any time. 

Once the trial finishes, you’ll receive information about the study’s outcomes. The study results will also be published in medical journals which contributes to advancing medical knowledge.