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

Author:

Fuchs‐Buder Thomas1ORCID,Brull Sorin J.2ORCID,Fagerlund Malin Jonsson3,Renew J. Ross4,Cammu Guy5,Murphy Glenn S.6,Warlé Michiel7,Vested Matias8,Fülesdi Béla9,Nemes Reka9,Columb Malachy O.10,Damian Daniela11,Davis Peter J.12,Iwasaki Hajime13,Eriksson Lars I.3

Affiliation:

1. Department of Anaesthesia Critical Care & Perioperative Medicine, University Hospital Nancy Nancy France

2. Mayo Clinic College of Medicine and Science Jacksonville Florida USA

3. Perioperative Medicine and Intensive Care Karolinska University Hospital Stockholm Sweden

4. Department of Anesthesiology and Perioperative Medicine Mayo Clinic Jacksonville Florida USA

5. Department of Anesthesiology Critical Care and Emergency Medicine Aalst Belgium

6. Department of Anesthesiology NorthShore University HealthSystem Chicago Illinois USA

7. Department of Surgery Radbound University Medical Center Nijmegen The Netherlands

8. Department of Anesthesia Rigshospitalet University of Copenhagen Copenhagen Denmark

9. Department of Anesthesiology and Intensive Care University of Debrecen Debrecen Hungary

10. Anaesthesia & Intensive Medicine Manchester University Hospitals NHS Foundation Trust Manchester UK

11. Anesthesiology and Perioperative Medicine UPMC Children's Hospital Pittsburgh Pennsylvania USA

12. Anesthesia and Pediatrics UPMC Children's Hospital Pittsburgh Pennsylvania USA

13. Department of Anesthesiology and Crtical Care Medicine Asahikawa Medical University Asahikawa Japan

Abstract

AbstractThe 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.

Publisher

Wiley

Subject

Anesthesiology and Pain Medicine,General Medicine

Reference109 articles.

1. Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents

2. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision

3. Good Clinical Practice for Trials on Medicinal Products in the European Community: CPMP Working Party on Efficacy of Medicinal Products

4. World Medical Association declaration of Helsinki.Ethical principles for medical research involving human subjects.https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/[accessed January 21 2023].

5. Good Clinical Practice Guidelinehttps://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice[accessed January 21 2023]

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3