WHY NEGATIVE RESULTS IN CLINICAL TRIALS MATTER
International Clinical Trials Day 2026, a year in review: Trial of The Year 2025
With
Professor Brett J. Manley, Consultant Neonatologist
Mercy Hospital For Women, Melbourne &
Professor of Neonatal Medicine,
Department of Obstetrics, Gynaecology and Newborn Health,
University of Melbourne, Australia
Kate Francis, Biostatistician (Snr Research Officer)
Murdoch Children’s Research Institute, Melbourne &
Honorary Research Fellow,
Department of Paediatrics,
University of Melbourne &
Affiliate Biostatistician, The Royal Children’s Hospital, Melbourne, Australia
Professor Christopher Reid, Chair
Australian Clinical Trials Alliance (ACTA) &
School of Public Health and Preventive Medicine, Monash University &
School of Population Health at Curtin University,
Western Australia
A BENCH SIDE STORY SYNDICATION
Filmed in Melbourne & Perth | May 2026
Negative results in a clinical trial can be extremely valuable — both scientifically and ethically. A “negative result” usually means the treatment being tested did not work better than the standard treatment, placebo, or expected outcome.
The aim of the PLUSS trial was to find out if installation of budesonide (a steroid) with surfactant to the lungs of extremely preterm babies helps to prevent lung disease, or Bronchopulmonary dysplasia (BPD).
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 respiratory distress syndrome (RDS). BPD is associated with mortality, and adverse long-term pulmonary and neurodevelopmental outcomes. Despite advances in neonatal care including antenatal corticosteroids, exogenous surfactant, and the increasing use of non-invasive respiratory support, the incidence of BPD has increased in the state of Victoria in 2005 compared with earlier eras.
Extremely preterm infants participating in the trial were monitored closely after birth and an assessment completed at 36 weeks to check for BPD. Participating infants were also followed up when they are two years old.
The trial was led by a team of researchers at the Royal Women’s Hospital, Melbourne and the Liggins Institute in Auckland, New Zealand and had 29 participating centres around the world.
In 2025 the PLUSS Trial received the Australian Clinical Trials Alliance (ACTA) Trial of the Year 2025 Award as well as the ACTA STInG Excellence in Trial Statistics Award2025.
Source: Adapted from plusstrial.org website
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