An Adaptive Platform Trial for Evaluating Treatments in Patients with Life-Threatening Hemorrhage from Traumatic Injuries: Ethical and US Regulatory Considerations
Transfusion(2022)
摘要
TransfusionEarly View Adaptive Platform Trial Design An adaptive platform trial for evaluating treatments in patients with life-threatening hemorrhage from traumatic injuries: Ethical and US regulatory considerations Sara F. Goldkind, Corresponding Author Sara F. Goldkind sfgoldkind@gmail.com Goldkind Consulting, LLC, Chevy Chase, Maryland, USA Correspondence Sara F. Goldkind, Goldkind Consulting, LLC, 5630 Wisconsin Avenue, Unit 807 Chevy Chase, MD 20815, USA. Email: sfgoldkind@gmail.comSearch for more papers by this authorLaura R. Brosch, Laura R. Brosch Uniformed Services University of the Health Sciences, Bethesda, Maryland, USASearch for more papers by this authorRoger J. Lewis, Roger J. Lewis Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California, USA Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA Berry Consultants, LLC, Austin, Texas, USASearch for more papers by this authorClaudia Pedroza, Claudia Pedroza Department of Pediatrics, McGovern Medical School at UT Health, The University of Texas Health Science Center at Houston, Houston, Texas, USASearch for more papers by this authorPhilip C. Spinella, Philip C. Spinella orcid.org/0000-0003-1721-0541 Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USASearch for more papers by this authorKabir Yadav, Kabir Yadav orcid.org/0000-0002-1092-9935 Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California, USA Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USASearch for more papers by this authorStacy A. Shackelford, Stacy A. Shackelford orcid.org/0000-0003-3585-2150 Joint Trauma System, Defense Health Agency, Joint Base San Antonio Fort Sam Houston, Fort Sam Houston, Texas, USASearch for more papers by this authorJohn B. Holcomb, John B. Holcomb orcid.org/0000-0001-8312-9157 Department of Surgery, Division of Acute Care Surgery, Center for Injury Science, University of Alabama at Birmingham, Birmingham, Alabama, USASearch for more papers by this author Sara F. Goldkind, Corresponding Author Sara F. Goldkind sfgoldkind@gmail.com Goldkind Consulting, LLC, Chevy Chase, Maryland, USA Correspondence Sara F. Goldkind, Goldkind Consulting, LLC, 5630 Wisconsin Avenue, Unit 807 Chevy Chase, MD 20815, USA. Email: sfgoldkind@gmail.comSearch for more papers by this authorLaura R. Brosch, Laura R. Brosch Uniformed Services University of the Health Sciences, Bethesda, Maryland, USASearch for more papers by this authorRoger J. Lewis, Roger J. Lewis Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California, USA Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA Berry Consultants, LLC, Austin, Texas, USASearch for more papers by this authorClaudia Pedroza, Claudia Pedroza Department of Pediatrics, McGovern Medical School at UT Health, The University of Texas Health Science Center at Houston, Houston, Texas, USASearch for more papers by this authorPhilip C. Spinella, Philip C. Spinella orcid.org/0000-0003-1721-0541 Department of Surgery and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USASearch for more papers by this authorKabir Yadav, Kabir Yadav orcid.org/0000-0002-1092-9935 Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California, USA Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USASearch for more papers by this authorStacy A. Shackelford, Stacy A. Shackelford orcid.org/0000-0003-3585-2150 Joint Trauma System, Defense Health Agency, Joint Base San Antonio Fort Sam Houston, Fort Sam Houston, Texas, USASearch for more papers by this authorJohn B. Holcomb, John B. Holcomb orcid.org/0000-0001-8312-9157 Department of Surgery, Division of Acute Care Surgery, Center for Injury Science, University of Alabama at Birmingham, Birmingham, Alabama, USASearch for more papers by this author First published: 24 June 2022 https://doi.org/10.1111/trf.16986Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Early ViewOnline Version of Record before inclusion in an issue RelatedInformation
更多查看译文
关键词
adaptive trials,clinical trial design,exception from informed consent,hemorrhagic shock,medical ethics,platform trials,trauma resuscitation
AI 理解论文
溯源树
样例
![](https://originalfileserver.aminer.cn/sys/aminer/pubs/mrt_preview.jpeg)
生成溯源树,研究论文发展脉络
Chat Paper
正在生成论文摘要