Challenge Trials

What are human challenge trials and why are they important?

A human infection challenge trial is a study design that allows researchers to advance the clinical development of potential breakthrough vaccines and therapeutics for infectious diseases, with the aim of making treatments more rapidly available to communities.

Human infection challenge trials involve applying a well-characterised infectious agent in healthy volunteer participants within a controlled environment. 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.

Human infection challenge studies offer unique opportunities during early-phase clinical development of antimicrobials and vaccines. These specialised studies can accelerate key decision making, save millions of dollars and substantially decrease timelines for clinical development.

Doherty Clinical Trials is dedicated to the ethical delivery of high-quality human challenge trials and the safety of our participants.

Human challenge trials are our specialty – we are the only unit in Australia specifically commissioned to deliver human challenge studies.

To read more about how human challenge trials can generate critical scientific insights and accelerate delivery of novel therapeutics and vaccines, download our fact sheet.

What are the advantages of running clinical trials in Australia?

‍Australia’s medical researchers, clinicians and facilities are among the best in the world. The Australian Government and the medical research community have invested in the people, in leading-edge equipment and infrastructure to deliver high-quality solutions.

Efficient regulatory frameworks are administered by the Therapeutic Goods Administration (TGA). Australia’s ethics process involves submitting research proposals directly to human research ethics committees. As a multicultural country, Australia has a potential pool of diverse participants to meet recruitment needs.

The Australian Government’s Research & Development (R&D) Tax Incentive encourages more industry investment in R&D. Contact our team – we can direct you to specialists who can help to maximise any R&D tax advantages for your project.

Read more about conducting a clinical trial in Australia.