The achievements of Australia's clinical trials sector took centre stage at the 2025 ACTA Trial of the Year Awards ceremony, commemorated on International Clinical Trials Day, Tuesday, May 20, 2025. Celebrating a diverse array of collaborative, multicenter trials driven by investigators nationwide, the event marked a significant milestone in healthcare innovation.
The prestigious awards that were bestowed during the ceremony, each highlight the profound impact these trials have on healthcare delivery and patient outcomes.
"Every nomination we receive underscores the remarkable expertise, determination, and creativity within Australia's clinical trials community," remarked Professor Chris Reid, ACTA Chair. "These trials not only shape healthcare practices domestically but also contribute to advancements globally."
The event welcomed distinguished guests including Professor Steve Wesselingh, CEO of NHMRC and Dr Kim Sutherland, Executive Director, Office for Health and Medical Research, NSW Ministry of Health.
Established in 2016, the ACTA Trial of the Year Awards spotlight exceptional Australian endeavours that enhance clinical practices and positively impact patient lives annually. This year's ceremony underscored Australia's pivotal role in driving forward clinical innovation on a global scale.
Congratulations to our 2025 winners
ACTA Trial of the Year Award winner
PLUSS - this trial investigated whether the administration of intra-tracheal budesonide during the early treatment of respiratory distress syndrome (RDS) in extremely preterm infants increased survival without bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age (PMA). This trial involved over 1,000 extremely premature babies in 21 hospitals across Australia, New Zealand, Singapore, and Canada.
Bronchopulmonary dysplasia (BPD) is a chronic inflammatory lung disease characterised by disordered alveolar and vascular development, most commonly affecting extremely preterm infants exposed to mechanical ventilation and oxygen therapy for RDS. BPD is associated with mortality, and adverse long-term pulmonary and neurodevelopmental outcomes.
This was a multicentre, two-arm, parallel, double-blind, randomised controlled trial.
PLUSS: Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants
Chief Investigator: Prof Brett Manley
Network or investigator group: Interdisciplinary Maternal Perinatal Australasian Collaborative Trials Network

Runners-up
PEAK trial - - Telerehabilitation consultations with a physiotherapist for chronic knee pain versus in-person consultations in Australia: the PEAK non-inferiority randomised controlled trial
Many people—both patients and physiotherapists—often think that seeing a physio in person is better than doing it online. But a major study called the PEAK trial set out to test that belief.
In this study, nearly 400 people with long-term knee pain, likely caused by osteoarthritis, were treated by physiotherapists in two ways. One group had traditional in-person appointments, while the other used video calls, like Zoom, to receive the same type of care—exercises, activity guidance, and education.
This trial was done across 27 clinics in Queensland and Victoria, and supported by Australia’s National Health & Medical Research Council.
The results? Both groups improved the same. Online physio was just as safe and effective as seeing a physio face to face.
This is great news. It means that people who can’t easily get to a clinic—whether they live far away, have mobility issues, or need flexible options—can still get top-quality care from the comfort of their home. It also means we should support and train physiotherapists to deliver care online, just like they do in person.
Chief Investigator: Prof Rana Hinman
Network or investigator group: Australia and New Zealand Musculoskeletal Clinical Trials Group

WalkBack: Effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention for the prevention of low back pain recurrence in Australia (WalkBack): a randomised controlled trial
Low back pain is the leading cause of disability worldwide. Currently management focusses on treating episodes of back pain rather than long-term prevention, despite strong evidence that recurrences are very common and a major contributor to the burden associated with back pain. The limited previous research into prevention of back pain found exercise and education may be effective in preventing back pain. However, these exercise programs were typically supervised, centre based, required equipment and thus reduces accessibility to many people.
Australia's NHMRC funded the WalkBack trial. The trial tested a personalized, progressive program of walking and education, facilitated by physiotherapists, which was delivered either in person or online. Seven hundred and one individuals who had recently recovered from an episode of low back pain were randomised to either receive the walking and education program, or to a no-intervention control group. All participants were followed monthly for up to 3 years, to monitor any new episodes of low back pain. The walking and education program significantly reduced the pain free period before a new recurrence, from 112 days in the no-intervention control group, to 208 days in the intervention group. Additionally, the intervention reduced the risk of needing to seek care for future low back pain by 43% and was also found to be cost-effective. The trial's success provides an effective and scalable prevention approach that is accessible to nearly everyone, even in remote areas. This has important implications for clinicians and should contribute to more focus on preventing back pain, instead of short-term treatment of episodes.
Chief Investigator: Prof Mark Hancock
Network or investigator group: - Australia and New Zealand Musculoskeletal Clinical Trials Group

ACTA STInG Excellence in Trial Statistics Award winner
PLUSS: Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants
The PLUSS clinical trial investigated whether the administration of intra-tracheal budesonide during the early treatment of respiratory distress syndrome (RDS) in extremely preterm infants increased survival without bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age (PMA).
This was a multicentre, double-blind, randomised controlled trial that enrolled over 1000 infants to ensure it was appropriately powered to answer the research question. The trial included transparent reporting of outcomes that were pre-specified in their publicly available, and peer reviewed statistical analysis plan
Lead Statistician: Kate Francis
Chief Investigator: Prof Brett Manley
Network or investigator group: Interdisciplinary Maternal Perinatal Australasian Collaborative Trials Network

Runner-up
BLING III - A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients
This trial was one of the biggest antibiotic studies ever done in ICUs, involving 7,202 patients across 104 ICUs in 7 countries. In total, over 132,000 doses were given. The results showed that giving antibiotics continuously helped more patients survive, improved recovery, and could save one extra life for every 26 patients treated this way. These findings are likely to change how doctors treat sepsis and will be used to update international treatment guidelines.
Lead Statistician: Prof Laurent Billot
Chief Investigator: Professor Jeffrey Lipman
Network or investigator group: The George Institute for Global Health
