DOHERTY CLINICAL TRIALS LIMITED

DOHERTY CLINICAL TRIALS LIMITED is a not-for-profit organisation and a subsidiary of the University of Melbourne, specialising in the delivery of innovative early phase clinical trials, including human challenge studies. Established by the Peter Doherty Institute for Infection and Immunity, it operates Australia’s first purpose-built facility specifically commissioned to conduct human challenge trials, which are designed to accelerate the development of novel medicines and vaccines by testing their safety and efficacy in controlled environments.

Mission and Vision

The mission of Doherty Clinical Trials Limited is to accelerate the development of breakthrough therapeutics and vaccines through ethically sound, high-quality clinical trials. Their vision is to be a global leader in early phase clinical research, providing bespoke trial solutions that reduce time and cost barriers while ensuring participant safety and scientific excellence.

Main Objectives

• Deliver early phase clinical studies with a focus on infectious diseases and immunology.
• Conduct human challenge trials to generate rapid and reliable data on vaccine and therapeutic efficacy.
• Provide tailored clinical trial design, protocol development, and comprehensive medical review to clients and researchers.
• Support translational research and experimental medicine through specialised facilities and expert teams.
• Maintain rigorous quality management systems to ensure compliance with international clinical trial standards.

Benefiting Groups

• Healthy volunteer participants who contribute to advancing medical research and receive professional care during trials.
• Researchers and pharmaceutical companies seeking efficient and scientifically robust clinical trial solutions.
• Healthcare systems and the broader community benefiting from accelerated development of effective vaccines and treatments.

Services and Activities

• Full operational delivery of early phase clinical trials requiring inpatient containment or isolation.
• Access to a range of human challenge models, including infectious agents like influenza, malaria, and Streptococcus pyogenes.
• Assistance with study design, protocol development, ethics and regulatory submissions.
• Participant recruitment and management within a purpose-built 25-bed facility equipped for specialised containment and isolation.
• Collaboration with leading biomedical research institutes and clinical experts to ensure high-quality trial conduct.