DOI
https://doi.org/10.1111/jpc.70326
Adaptive platform trials (APTs) are transforming the way clinical research is conducted, as they are able to efficiently evaluate multiple interventions simultaneously. PLATIPUS (Platform for Adaptive Trial in Perinatal Units) is the world’s first perinatal APT with multi-stakeholder involvement, providing a global model for integrating lived experience in to complex trials. The PLATIPUS Lived Experience Committee (LEC) embeds parents across trial design, governance and operational decision-making.
The PLATIPUS LEC demonstrates a scalable, innovative model for embedding lived experience across all aspects of APTs, positioning Australia and New Zealand at the forefront of globally significant perinatal clinical research.
DOI
https://doi.org/10.1111/jpc.70326
Preterm birth remains a major cause of neonatal morbidity and mortality worldwide. Priority-setting processes aim to identify unanswered questions to focus future research activities. However, methods used vary widely and often lack stakeholder inclusiveness.
This systematic review aimed to identify existing research priorities for clinical trials focused on preterm birth and critically examine the methods used to develop them, with specific attention to stakeholder representation, transparency, and equity.
DOI
https://doi.org/10.1016/j.jval.2026.03.001
Adaptive platform trials (APTs) present an unprecedented opportunity to enhance clinical trial efficiency and accelerate decision-making. Limited evidence exists on how health economic evaluation studies are planned or conducted alongside APTs for translation and resource allocation. This review aims to identify and synthesise published evidence on the planning and conduct of economic evaluations (EEs) alongside the flexible APT design.
DOI
https://doi.org/10.1111/ajo.70039
Preterm prelabour rupture of membranes (PPROM) is a common obstetric complication with significant maternal and foetal consequences. There is a lack of contemporary evidence regarding the optimal management of PPROM, including the best antibiotic regimen and management at previable gestations.
In a survey of contemporary management of PPROM among clinicians in Australia and Aotearoa New Zealand, a wide variation in clinical practice management of PPROM was observed.
A national consensus regarding optimal management of this common pregnancy complication is required. The Preterm Rupture of Membranes Optimal Antibiotic Trial (PROMOAT), a pregnancy domain within PLATIPUS, will help to address this priority.
DOI
10.1016/S2352-4642(24)00328-6
In this Viewpoint, we discuss the challenges facing perinatal clinical researchers, many of which are unique to this field, and how traditional two-arm randomised trials using frequentist analysis might no longer be fit for purpose for perinatology. We propose a solution: the adoption of adaptive platform trials (APTs) with Bayesian methodology to address perinatal research questions to improve outcomes of preterm birth. APTs use a master protocol as a foundation to efficiently assess multiple interventions simultaneously for a particular disease. APTs can study these interventions in a perpetual manner, with interventions allowed to enter or leave the platform on the basis of preplanned decision algorithms. In this Viewpoint, we outline the ways in which APTs can overcome some of the issues facing perinatal clinical research, and the challenges and essential requirements for the design and implementation of perinatal APTs that should be considered.
DOI
10.1186/s13063-024-08072-2
Randomised controlled trials (RCTs) aim to estimate the causal effect of one or more interventions relative to a control. One type of outcome that can be of interest in an RCT is an ordinal outcome, which is useful to answer clinical questions regarding complex and evolving patient states. The target parameter of interest for an ordinal outcome depends on the research question and the assumptions the analyst is willing to make. This review aimed to provide an overview of how ordinal outcomes have been used and analysed in RCTs.
DOI
10.1136/archdischild-2024-326874
The largest randomised controlled trial (RCT) of neonatal caffeine therapy, the Caffeine for Apnea of Prematurity (CAP) trial, evaluated caffeine citrate at a loading dose of 20 mg/kg and a maintenance dose of 5–10 mg/kg/day.1 Although caffeine is among the most commonly used neonatal medications, practice varies widely, and higher dosing has been reported.2 We hypothesised that caffeine practice may have evolved since the last survey conducted in the Australian and New Zealand Neonatal Network (ANZNN),3 despite limited data supporting higher caffeine doses.2 We aimed to describe the current use of caffeine in very preterm infants as a fundamental step towards large RCTs of caffeine dosing.