Clinical research, including clinical trials, test the safety and effectiveness of medications, medical devices, and diagnostic tests in humans. Clinical research is how new medical discoveries are tested before becoming available as treatments or medications. Cohort studies are longitudinal studies of a group of individuals with a specific condition or behaviour to understand how the condition or behaviour changes over time and impacts on the individual’s health. The Kirby Institute is a global leader in clinical research, clinical trials and cohort studies in infectious diseases with a particular focus on marginalised populations.
The Kirby Institute has a long history in clinical research dating back to the mid-1980's with the Sydney AIDS Prospective study (SAPS), a large cohort study that collected data on the sexual behaviour of Australian gay men, leading on to some of Australia’s first clinical trials of the new medications to treat HIV and AIDS. Since then, and for over three decades now, we have led clinical research in a large number of infectious diseases including HIV/AIDS, viral hepatitis, sexually transmissible infections, neglected tropical diseases, and more recently taken a leading role in COVID-19 research in Australia and internationally.
Through strong research networks and collaborations, the Kirby Institute has designed and conducted large-scale clinical trials and cohorts in Australia and across the globe including in low- and middle- income countries, resulting in changes to clinical practice and improved health among affected communities.
Clinical research at the Kirby Institute has always engaged, consulted, and worked in partnership with affected communities and the clinical sites and community organisations that support them.
The Kirby Institute strives to provide high quality real-world data to inform international guidelines that prevent, test for and treat infectious diseases.
Some examples of this high-impact work include:
- Demonstration that lower doses of HIV anti-retroviral medications are safe and effective through the ENCORE study, changing HIV treatment guidelines and providing cost effective HIV treatment options particularly in low- and middle- income countries.
- Demonstration of when to start HIV treatment for optimal patient care through the START study, which has informed WHO treatment guidelines.
- We have led some of the world’s largest and most robust clinical trials that demonstrated that the new direct acting antivirals (DAA) for the treatment of hepatitis C were safe and effective in people who inject drugs, providing the real-world data to change global hepatitis C treatment guidelines.
- We play a global leadership role in some of the world’s largest clinical trials networks, including the INSIGHT network, a major international collaboration for the conduct of large clinical trials in HIV, COVID-19 and other viruses, which has more than 300 sites in 30 countries.
Programs working in this area:
- Therapeutic and Vaccine Research Program
- Viral Hepatitis Clinical Research Program
- Viral Hepatitis Epidemiology and Prevention Program