• Pediatr Crit Care Me · Dec 2022

    Multicenter Study Pragmatic Clinical Trial

    The United Kingdom Paediatric Critical Care Society Study Group: The 20-Year Journey Toward Pragmatic, Randomized Clinical Trials.

    • Mark J Peters, Padmanabhan Ramnarayan, Barnaby R Scholefield, Lyvonne N Tume, Robert C Tasker, and United Kingdom Paediatric Critical Care Society Study Group (PCCS-SG).
    • Respiratory Critical Care and Anaesthesia Unit, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.
    • Pediatr Crit Care Me. 2022 Dec 1; 23 (12): 106710751067-1075.

    AbstractOver the past two decades, pediatric intensive care research networks have been formed across North America, Europe, Asia, and Australia/New Zealand. The U.K. Paediatric Critical Care Society Study Group (PCCS-SG) has over a 20-year tradition of fostering collaborative research, leading to the design and successful conduct of randomized clinical trials (RCTs). To date, the PCCS-SG network has delivered 13 different multicenter RCTs, covering a spectrum of study designs, methodologies, and scale. Lessons from the early years have led PCCS-SG to now focus on the entire process needed for developing an RCT, starting from robust preparatory steps such as surveys, data analysis, and feasibility work through to a definitive RCT. Pilot RCTs have been an important part of this process as well. Facilitators of successful research have included the presence of a national registry to facilitate efficient data collection; close partnerships with established Clinical Trials Units to bring together clinicians, methodologists, statisticians, and trial managers; greater involvement of transport teams to recruit patients early in trials of time-sensitive interventions; and the funded infrastructure of clinical research staff within the National Health Service to integrate research within the clinical service. The informal nature of PCCS-SG has encouraged buy-in from clinicians. Greater international collaboration and development of embedded trial platforms to speed up the generation and dissemination of trial findings are two key future strategic goals for the PCCS-SG research network.Copyright © 2022 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.

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