Changing the way clinical trials are conducted may be the best way of improving outcomes for premature babies, according to latest research led by Mercy Health’s Professor Brett Manley.
Published in The Lancet Child & Adolescent Health, Brett’s research suggests that Adaptive Platform Trials have the potential to answer real-world questions in perinatal research.
Preterm birth is the leading cause of death and disability in children younger than five years, and affects more than 13 million infants each year globally.
“Preterm birth rates have not decreased in the last 20 years, and the societal cost is enormous and continues to be the leading cause of lost human capital worldwide,” said Brett. “Perinatal clinical trials are challenging to conduct and slow to translate into improved health outcomes.”
Brett and his collaborators (including The Royal Women’s Hospital, The University of Melbourne, Murdoch Children’s Research Institute and others) suggest that traditional two-arm randomised trials may no longer be fit for purpose for perinatal research.
“We propose a solution: the adoption of Adaptive Platform Trials (APTs) to improve outcomes of preterm birth,” said Brett.
APTs have been used extensively in oncology for more than 30 years and more recently in infectious disease research.
“We believe APTs have the potential to efficiently and sustainably answer real-world questions in perinatal research due to their adaptability, infrastructure and human resources,” said Brett.
Large-scale adaptive platform trials that facilitate international collaboration could lead the way to addressing important questions for perinatal research.
“This new approach could overcome some issues that are holding back perinatal clinical research,” said Brett.
Importantly, Brett’s research may lead to interventions that not only prevent preterm birth but also reduce the complications of preterm birth.
-Professor Brett Manley
Last reviewed March 3, 2025.
