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...
Gespeichert in:
Veröffentlicht in: | Acta anaesthesiologica Scandinavica 2023-09, Vol.67 (8), p.994-1017 |
---|---|
Hauptverfasser: | , , , , , , , , , , , , , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | 1017 |
---|---|
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 |
format | Article |
fullrecord | <record><control><sourceid>proquest_swepu</sourceid><recordid>TN_cdi_swepub_primary_oai_swepub_ki_se_445595</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2852437684</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4269-c2a656bceea953576e0401c1692102f2e6d3b9d222aaf91deb71734e24f75a43</originalsourceid><addsrcrecordid>eNp1kUFvEzEQhS0EoiFw4A8gS1zaw7a2196NuUVRCZEqgSB3a9Y727jdtYOdbZUbPx2XDT0g4ct4Rp_ezNMj5D1nlzy_K4B0yaWo9Qsy46XWRaXq6iWZMcZ4oXgtzsiblO5yW0qtX5Ozsi6lWtRsRn6tQ2ip7Z13FnoaMSFEu6P7CPbgLNLz9er7twvqPN3vIA5gQ3v0MDhL02FsHSYaOupxjGEYkx17iLTpg713_pbCLfpDopvN5hPd7pAKJkq6Ro8PkDc9uOSCf0teddAnfHeqc7L9fL1dfSluvq43q-VNYaWodGEFVKpqLCJoVWZ7yCTjlldacCY6gVVbNroVQgB0mrfY1DybRCG7WoEs56SYZNMj7sfG7KMbIB5NAGdOo_v8QyOlUnnDnJxP_D6GnyOmgxlcstj34DGMyYiFWNRKC8Uy-vEf9C6M0WczmVJClnW1eDrgYqJsDClF7J5P4Mw8pWhyiuZPipn9cFIcmwHbZ_JvbBm4moBH1-Px_0pmufwxSf4G3NqlwQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2852437684</pqid></control><display><type>article</type><title>Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision</title><source>Wiley Online Library Journals Frontfile Complete</source><source>SWEPUB Freely available online</source><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.</creator><creatorcontrib>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.</creatorcontrib><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.</description><identifier>ISSN: 0001-5172</identifier><identifier>EISSN: 1399-6576</identifier><identifier>DOI: 10.1111/aas.14279</identifier><identifier>PMID: 37345870</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Clinical trials ; depth of neuromuscular blockade ; Electromyography ; Guidelines ; neuromuscular monitoring ; neuromuscular research ; Observational studies ; Pharmacodynamics ; Pharmacology ; postoperative pulmonary complications ; time course of neuromuscular blockade</subject><ispartof>Acta anaesthesiologica Scandinavica, 2023-09, Vol.67 (8), p.994-1017</ispartof><rights>2023 The Authors. published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.</rights><rights>2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.</rights><rights>2023. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4269-c2a656bceea953576e0401c1692102f2e6d3b9d222aaf91deb71734e24f75a43</citedby><cites>FETCH-LOGICAL-c4269-c2a656bceea953576e0401c1692102f2e6d3b9d222aaf91deb71734e24f75a43</cites><orcidid>0000-0002-8041-1234 ; 0000-0003-2607-2590</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Faas.14279$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Faas.14279$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37345870$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:152962677$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Fuchs‐Buder, Thomas</creatorcontrib><creatorcontrib>Brull, Sorin J.</creatorcontrib><creatorcontrib>Fagerlund, Malin Jonsson</creatorcontrib><creatorcontrib>Renew, J. Ross</creatorcontrib><creatorcontrib>Cammu, Guy</creatorcontrib><creatorcontrib>Murphy, Glenn S.</creatorcontrib><creatorcontrib>Warlé, Michiel</creatorcontrib><creatorcontrib>Vested, Matias</creatorcontrib><creatorcontrib>Fülesdi, Béla</creatorcontrib><creatorcontrib>Nemes, Reka</creatorcontrib><creatorcontrib>Columb, Malachy O.</creatorcontrib><creatorcontrib>Damian, Daniela</creatorcontrib><creatorcontrib>Davis, Peter J.</creatorcontrib><creatorcontrib>Iwasaki, Hajime</creatorcontrib><creatorcontrib>Eriksson, Lars I.</creatorcontrib><title>Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision</title><title>Acta anaesthesiologica Scandinavica</title><addtitle>Acta Anaesthesiol Scand</addtitle><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.</description><subject>Clinical trials</subject><subject>depth of neuromuscular blockade</subject><subject>Electromyography</subject><subject>Guidelines</subject><subject>neuromuscular monitoring</subject><subject>neuromuscular research</subject><subject>Observational studies</subject><subject>Pharmacodynamics</subject><subject>Pharmacology</subject><subject>postoperative pulmonary complications</subject><subject>time course of neuromuscular blockade</subject><issn>0001-5172</issn><issn>1399-6576</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>D8T</sourceid><recordid>eNp1kUFvEzEQhS0EoiFw4A8gS1zaw7a2196NuUVRCZEqgSB3a9Y727jdtYOdbZUbPx2XDT0g4ct4Rp_ezNMj5D1nlzy_K4B0yaWo9Qsy46XWRaXq6iWZMcZ4oXgtzsiblO5yW0qtX5Ozsi6lWtRsRn6tQ2ip7Z13FnoaMSFEu6P7CPbgLNLz9er7twvqPN3vIA5gQ3v0MDhL02FsHSYaOupxjGEYkx17iLTpg713_pbCLfpDopvN5hPd7pAKJkq6Ro8PkDc9uOSCf0teddAnfHeqc7L9fL1dfSluvq43q-VNYaWodGEFVKpqLCJoVWZ7yCTjlldacCY6gVVbNroVQgB0mrfY1DybRCG7WoEs56SYZNMj7sfG7KMbIB5NAGdOo_v8QyOlUnnDnJxP_D6GnyOmgxlcstj34DGMyYiFWNRKC8Uy-vEf9C6M0WczmVJClnW1eDrgYqJsDClF7J5P4Mw8pWhyiuZPipn9cFIcmwHbZ_JvbBm4moBH1-Px_0pmufwxSf4G3NqlwQ</recordid><startdate>202309</startdate><enddate>202309</enddate><creator>Fuchs‐Buder, Thomas</creator><creator>Brull, Sorin J.</creator><creator>Fagerlund, Malin Jonsson</creator><creator>Renew, J. Ross</creator><creator>Cammu, Guy</creator><creator>Murphy, Glenn S.</creator><creator>Warlé, Michiel</creator><creator>Vested, Matias</creator><creator>Fülesdi, Béla</creator><creator>Nemes, Reka</creator><creator>Columb, Malachy O.</creator><creator>Damian, Daniela</creator><creator>Davis, Peter J.</creator><creator>Iwasaki, Hajime</creator><creator>Eriksson, Lars I.</creator><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>7X8</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope><orcidid>https://orcid.org/0000-0002-8041-1234</orcidid><orcidid>https://orcid.org/0000-0003-2607-2590</orcidid></search><sort><creationdate>202309</creationdate><title>Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision</title><author>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.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4269-c2a656bceea953576e0401c1692102f2e6d3b9d222aaf91deb71734e24f75a43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Clinical trials</topic><topic>depth of neuromuscular blockade</topic><topic>Electromyography</topic><topic>Guidelines</topic><topic>neuromuscular monitoring</topic><topic>neuromuscular research</topic><topic>Observational studies</topic><topic>Pharmacodynamics</topic><topic>Pharmacology</topic><topic>postoperative pulmonary complications</topic><topic>time course of neuromuscular blockade</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fuchs‐Buder, Thomas</creatorcontrib><creatorcontrib>Brull, Sorin J.</creatorcontrib><creatorcontrib>Fagerlund, Malin Jonsson</creatorcontrib><creatorcontrib>Renew, J. Ross</creatorcontrib><creatorcontrib>Cammu, Guy</creatorcontrib><creatorcontrib>Murphy, Glenn S.</creatorcontrib><creatorcontrib>Warlé, Michiel</creatorcontrib><creatorcontrib>Vested, Matias</creatorcontrib><creatorcontrib>Fülesdi, Béla</creatorcontrib><creatorcontrib>Nemes, Reka</creatorcontrib><creatorcontrib>Columb, Malachy O.</creatorcontrib><creatorcontrib>Damian, Daniela</creatorcontrib><creatorcontrib>Davis, Peter J.</creatorcontrib><creatorcontrib>Iwasaki, Hajime</creatorcontrib><creatorcontrib>Eriksson, Lars I.</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>Acta anaesthesiologica Scandinavica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fuchs‐Buder, Thomas</au><au>Brull, Sorin J.</au><au>Fagerlund, Malin Jonsson</au><au>Renew, J. Ross</au><au>Cammu, Guy</au><au>Murphy, Glenn S.</au><au>Warlé, Michiel</au><au>Vested, Matias</au><au>Fülesdi, Béla</au><au>Nemes, Reka</au><au>Columb, Malachy O.</au><au>Damian, Daniela</au><au>Davis, Peter J.</au><au>Iwasaki, Hajime</au><au>Eriksson, Lars I.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision</atitle><jtitle>Acta anaesthesiologica Scandinavica</jtitle><addtitle>Acta Anaesthesiol Scand</addtitle><date>2023-09</date><risdate>2023</risdate><volume>67</volume><issue>8</issue><spage>994</spage><epage>1017</epage><pages>994-1017</pages><issn>0001-5172</issn><eissn>1399-6576</eissn><abstract>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.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>37345870</pmid><doi>10.1111/aas.14279</doi><tpages>24</tpages><orcidid>https://orcid.org/0000-0002-8041-1234</orcidid><orcidid>https://orcid.org/0000-0003-2607-2590</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0001-5172 |
ispartof | Acta anaesthesiologica Scandinavica, 2023-09, Vol.67 (8), p.994-1017 |
issn | 0001-5172 1399-6576 |
language | eng |
recordid | cdi_swepub_primary_oai_swepub_ki_se_445595 |
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 |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-12T18%3A56%3A34IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Good%20clinical%20research%20practice%20(GCRP)%20in%20pharmacodynamic%20studies%20of%20neuromuscular%20blocking%20agents%20III:%20The%202023%20Geneva%20revision&rft.jtitle=Acta%20anaesthesiologica%20Scandinavica&rft.au=Fuchs%E2%80%90Buder,%20Thomas&rft.date=2023-09&rft.volume=67&rft.issue=8&rft.spage=994&rft.epage=1017&rft.pages=994-1017&rft.issn=0001-5172&rft.eissn=1399-6576&rft_id=info:doi/10.1111/aas.14279&rft_dat=%3Cproquest_swepu%3E2852437684%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2852437684&rft_id=info:pmid/37345870&rfr_iscdi=true |