Yes. Healthy people can join certain clinical trials in Australia. In fact, some studies specifically recruit healthy volunteers rather than people living with a particular health condition.
Healthy volunteers are commonly involved in Phase 1 clinical trials, bioequivalence studies and other research looking at how a medicine behaves in the body. These studies are carefully monitored and have specific eligibility requirements to determine who can participate.
Why do clinical trials need healthy volunteers?
Healthy volunteers can help researchers understand how an investigational medicine behaves in the body without the additional effects of an underlying health condition.
In early-stage research, this can help researchers answer important questions such as:
- How well is it tolerated? Researchers may start with a low dose and carefully increase it while monitoring participants for side effects.
- What does the body do to it? Researchers can study how quickly it is absorbed, how it moves through the body and how it is removed.
- What does it do to the body? Researchers may monitor things like heart rhythm, blood pressure, blood counts and liver function.
Information collected from healthy volunteers can help researchers determine appropriate doses and monitoring requirements before an investigational treatment is studied more widely in people with the condition it is designed to treat.
Which clinical trials use healthy volunteers?
Not every clinical trial needs healthy volunteers. The type of participants required depends on the research question and study design.
Studies that may recruit healthy volunteers include:
| Study type | What it may involve |
|---|---|
| Phase 1 studies | Early testing of an investigational treatment, sometimes involving increasing doses and residential stays. |
| Bioequivalence studies | Comparing how different versions or formulations of a medicine behave in the body. |
| Vaccine studies | Assessing immune responses and safety, often with follow-up visits over a period of time. |
| Drug interaction or food-effect studies | Looking at how a medicine behaves when taken with another medicine or with food. |
| Imaging and biomarker studies | Research involving measurements, scans or samples to better understand biological processes. |
Some Phase 1 studies are residential, meaning participants stay at a clinical research facility for one or more nights. Meals, accommodation and study-related monitoring are generally provided during the stay.
Who qualifies as a healthy volunteer?
There is no single definition of a healthy volunteer that applies to every clinical trial. Each study has its own eligibility criteria.
Depending on the study, researchers may consider:
- Your age and BMI
- Your general health and medical history
- Prescription and non-prescription medications you take
- Results from blood tests, an ECG and other screening assessments
- Smoking, alcohol or recreational drug use
- Pregnancy, breastfeeding and contraception requirements
- Recent blood donation
- Previous participation in clinical research
Being generally healthy does not automatically mean you will qualify. Before joining, you will usually complete a screening process that may include blood and urine tests, an ECG, vital signs, a physical examination and a review of your medical history.
If you do not meet the criteria for one study, it does not mean there is something wrong with your health. It may simply mean that you do not meet the specific requirements of that particular study.
What is involved in a healthy volunteer clinical trial?
What participation looks like will depend on the study. Some involve a small number of outpatient appointments, while others may require an overnight or multi-day residential stay.
Screening: You may have blood and urine tests, an ECG, vital signs, a physical examination and questions about your health and medical history.
Dosing: If the study involves an investigational medicine, you may receive a dose followed by regular monitoring. This can include blood samples, heart rate and blood pressure checks, ECGs and other assessments.
During a residential stay: Meals and accommodation are generally provided. There may also be restrictions around food, caffeine, alcohol, nicotine, exercise or other activities so researchers can collect consistent results.
Follow-up: You may need to return for one or more appointments after dosing so the research team can complete additional safety checks.
Before agreeing to participate, you should be told about the expected time commitment, procedures and restrictions involved.
Are healthy volunteers paid for clinical trials in Australia?
Healthy volunteer clinical trials in Australia may provide payment or reimbursement for the time, travel and inconvenience involved in participating.
The amount varies between studies and may depend on factors such as the number of appointments, procedures, residential stays and overall time commitment.
Payment information should be explained before you agree to participate, including how and when payments are made and what happens if you decide to withdraw from the study early.
Payment should not be considered a benefit of the investigational treatment itself. Your decision about whether to participate should also take into account the procedures, restrictions, time commitment and potential risks involved.
Are healthy volunteer clinical trials safe?
Clinical trials are designed with measures to protect participant safety, but no clinical trial is completely without risk.
Early-phase studies may involve investigational treatments for which there is less information from human use. For this reason, participants can undergo regular or intensive monitoring during and after dosing.
Depending on the study, safety measures may include staged dosing, frequent blood tests, ECGs, blood pressure checks and medical staff available to respond if a participant experiences a reaction or side effect.
Before deciding whether to participate, you should be given information about the known and potential risks of the study and have an opportunity to ask the research team questions.
What should I check before applying for a healthy volunteer study?
Before applying, it can help to understand:
- What the study is researching and what is known about the investigational treatment.
- The total time commitment, including screening, residential stays and follow-up appointments.
- The procedures involved, such as blood tests, ECGs or other assessments.
- Any restrictions relating to food, alcohol, caffeine, exercise, medications or other activities.
- Payment or reimbursement arrangements, including what happens if you withdraw before completing the study.
- Who is conducting the research and who you can contact if you have questions or concerns.
You should receive information about the study before deciding whether to participate and have the opportunity to ask questions.
How do I find a healthy volunteer clinical trial?
Healthy volunteer clinical trials are conducted at research sites across Australia, and some research organisations allow you to register your interest in upcoming studies.
When you find a study you're interested in, the first step is often a short pre-screening questionnaire. This checks whether you may meet the study's basic eligibility requirements before progressing to formal screening.
It can help to have a list of any medications and supplements you take, details of previous clinical trial participation and information about recent blood donations ready before you begin.
If you regularly donate blood, check the study's eligibility requirements before your next donation. Some studies have specific time periods between blood donation and participation.