Screening Process

A clinical trial is an investigation where medications, vaccines and other therapies are tested on people who volunteer to participate.

Doherty Clinical Trials performs what is known as early phase trials. Participants in early phase trials are usually healthy volunteers and the investigation is designed to see if the potential treatment or vaccine is safe. Later phase trials can investigate whether a treatment works or is better than any treatment already available.

A human challenge trial is a type of early phase clinical trial that allows researchers to better understand the immune system and infectious diseases, and to also rapidly test the effectiveness of vaccines and treatments.

Human challenge trials involve applying a well-characterised infectious agent (such as a bacterium or virus) in healthy volunteer participants within a controlled environment. A well-characterised infectious agent means that researchers have accurate and thorough details on the make-up of the bacterium or virus that is being tested. Participants are monitored closely by a medical team, with clinical observations and tests helping researchers better understand the effectiveness of potential vaccines and treatments in preventing and controlling infection.

When testing a new vaccine or treatment, the infectious agent is applied either after the volunteer has been vaccinated with the trial study vaccine, or before they have received the treatment in development. This order of events allows the vaccine or therapy to be tested for safety and effectiveness.

These trials are carefully designed to ensure researchers learn meaningful information with the greatest potential to decrease the impact of infectious diseases globally.

The COVID-19 pandemic has taught us the importance of being able to rapidly understand infectious pathogens and produce and test effective vaccines and treatments to decrease global disease and deaths.

Human challenge trials give critical real-time information which allows for rapid development of effective vaccines and treatments, with the potential to decrease the impact of infectious diseases globally.

Human challenge trials have been used to develop new medicines and vaccines globally for decades and have contributed to the research and development of vaccines and/or treatments for:

• Cholera
• Rhinovirus
• Malaria
• Influenza
• Dengue
• Typhoid fever
• Gastrointestinal infections (e.g. those cause by Norovirus, Salmonella and E.coli)
• COVID-19

As a participant in a clinical trial, you will be reimbursed for your time, travel expenses and parking, including for trials involving visits to clinics during the day.

For human challenge trials, you may need to stay on site for several days. So depending on the length of the trial, the reimbursement amounts can add up.

Reimbursements are not assessable income for tax purposes and don’t impact social welfare payments.

If you can’t complete the trial, you’ll get a partial payment to cover your time. You might not be paid for screening appointments unless this is specified in advance.

Human challenge trials in Australia adhere to a high level of stringent ethical and regulatory requirements. The rights and safety of all participants are always of paramount importance and robust ethical frameworks are in place to guide researchers.

All trials are approved by an experience, independent Human Research Ethics Committee registered with Australia's National Health and Medical Research Council. Australia has strict requirements for clinical trials and we follow all guidelines and regulatory requirements including those set out by the principles of Good Clinical Practice, the Therapeutic Goods Administration and Medicines Australia.

Like any medication, vaccine or treatment (and even some over-the-counter products), human challenge trials carry some risk and potential side effects. To minimise any risk, all the infectious pathogens used are very well understood and all treatments or vaccines have already been tested for safety over many years before they are used in human challenge trials.

We believe it is important that researchers involved in human challenge trials continually assess the risks and benefits of these types of trials to uphold the safety of participants. We also ensure that all participants are fully informed of any risks and benefits, have ample opportunity to ask questions and feel comfortable before they consent to enrolling and participating in our studies.

The types of people who can participate in each trial depends on the purpose of the trial and the information the researchers would like to collect. The type of participant required for each study is dependent on the specific trial and will be described in the recruitment materials. This will give you an early idea about what the researchers are looking for. The early screening process will give you more information about your eligibility.

During the screening process, our team will advise you if you are suitable for the trial in progress. If you are not, there may be other trials for which you fill the selection criteria.

All clinical trials have criteria for participants. These are designed to decrease risk for participants and help researchers select the people who help them answer the research questions the trial is investigating.

All volunteers will need to provide consent to participate and will be asked to answer medical questions specific to the trial. You will be assessed by a doctor and have medical examinations to make sure it is safe for you to be involved in the trial. To understand what you can expect during the screening process, visit our patient screening process page.

Human challenge trials often require a short stay in a clinical unit. In some cases, participants may be quarantined and isolated from other participants until the end of the challenge period, when they can resume normal activities. After a short stay in the unit, participants may have follow-up appointments in the future, either in person or over the phone.

At Doherty Clinical Trials, participants in our trials stay in Australia’s only unit specifically devoted to human challenge studies. In addition to the highest quality facilities for our researchers, as a participant our team will make sure you are well looked after and that you are comfortable, healthy and safe at all times.

All meals are provided and we can accommodate your dietary requirements. The space includes areas for relaxation and work, where participants will have access to complimentary entertainment – TVs, gaming consoles and WiFi. All our individual rooms are equipped with a bed, private en-suite bathroom and desk, where participants can set up their own laptops for study, work or for a chat with friends and family.