Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision

The set of guidelines for good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents was developed following an international consensus conference in Copenhagen in 1996 (Viby‐Mogensen et al., Acta Anaesthesiol Scand 1996, 40, 59–74); the guidelines were later revised...

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Veröffentlicht in:Acta anaesthesiologica Scandinavica 2023-09, Vol.67 (8), p.994-1017
Hauptverfasser: Fuchs‐Buder, Thomas, Brull, Sorin J., Fagerlund, Malin Jonsson, Renew, J. Ross, Cammu, Guy, Murphy, Glenn S., Warlé, Michiel, Vested, Matias, Fülesdi, Béla, Nemes, Reka, Columb, Malachy O., Damian, Daniela, Davis, Peter J., Iwasaki, Hajime, Eriksson, Lars I.
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container_issue 8
container_start_page 994
container_title Acta anaesthesiologica Scandinavica
container_volume 67
creator Fuchs‐Buder, Thomas
Brull, Sorin J.
Fagerlund, Malin Jonsson
Renew, J. Ross
Cammu, Guy
Murphy, Glenn S.
Warlé, Michiel
Vested, Matias
Fülesdi, Béla
Nemes, Reka
Columb, Malachy O.
Damian, Daniela
Davis, Peter J.
Iwasaki, Hajime
Eriksson, Lars I.
description The set of guidelines for good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents was developed following an international consensus conference in Copenhagen in 1996 (Viby‐Mogensen et al., Acta Anaesthesiol Scand 1996, 40, 59–74); the guidelines were later revised and updated following the second consensus conference in Stockholm in 2005 (Fuchs‐Buder et al., Acta Anaesthesiol Scand 2007, 51, 789–808). In view of new devices and further development of monitoring technologies that emerged since then, (e.g., electromyography, three‐dimensional acceleromyography, kinemyography) as well as novel compounds (e.g., sugammadex) a review and update of these recommendations became necessary. The intent of these revised guidelines is to continue to help clinical researchers to conduct high‐quality work and advance the field by enhancing the standards, consistency, and comparability of clinical studies. There is growing awareness of the importance of consensus‐based reporting standards in clinical trials and observational studies. Such global initiatives are necessary in order to minimize heterogeneous and inadequate data reporting and to improve clarity and comparability between different studies and study cohorts. Variations in definitions of endpoints or outcome variables can introduce confusion and difficulties in interpretation of data, but more importantly, it may preclude building of an adequate body of evidence to achieve reliable conclusions and recommendations. Clinical research in neuromuscular pharmacology and physiology is no exception.
doi_str_mv 10.1111/aas.14279
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source Wiley Online Library Journals Frontfile Complete; SWEPUB Freely available online
subjects Clinical trials
depth of neuromuscular blockade
Electromyography
Guidelines
neuromuscular monitoring
neuromuscular research
Observational studies
Pharmacodynamics
Pharmacology
postoperative pulmonary complications
time course of neuromuscular blockade
title Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision
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