从SCOPE脊髓损伤神经恢复性临床试验的经验教训和建议更新。

IF 1.8 Q3 CLINICAL NEUROLOGY
Neurotrauma reports Pub Date : 2025-03-05 eCollection Date: 2025-01-01 DOI:10.1089/neur.2024.0163
Bethany R Kondiles, Sabhya Rana, David Weiner, Armin Blesch, James St John, Cornelia Haag-Molkenteller, Patrick Freund, James Guest, Daniel D Mikol, Susan Harkema, Randy D Trumbower, Michael G Fehlings, Norbert Weidner, Gary S Hogge, Edelle C Field-Fote, Marco A S Baptista, Armin Curt, Jane Hsieh, Linda Jones
{"title":"从SCOPE脊髓损伤神经恢复性临床试验的经验教训和建议更新。","authors":"Bethany R Kondiles, Sabhya Rana, David Weiner, Armin Blesch, James St John, Cornelia Haag-Molkenteller, Patrick Freund, James Guest, Daniel D Mikol, Susan Harkema, Randy D Trumbower, Michael G Fehlings, Norbert Weidner, Gary S Hogge, Edelle C Field-Fote, Marco A S Baptista, Armin Curt, Jane Hsieh, Linda Jones","doi":"10.1089/neur.2024.0163","DOIUrl":null,"url":null,"abstract":"<p><p>The Spinal Cord Outcomes Partnership Endeavors presented a clinical trials update (CTU) in collaboration with the International Spinal Research Trust as a precourse to their annual meeting. Selected trials adhered to <i>a priori</i> considerations, prioritizing novelty and a focus on neurorestorative approaches. The sessions featured 13 speakers, covering 4 in-preparation, 4 in-progress, and 4 recently completed trials. In addition to in-person attendance, individuals worldwide viewed a live stream of the presentations. Approximately 1600 participants, comprising clinicians, researchers, industry stakeholders, foundations, and individuals with lived experiences, engaged in the CTU through both in-person and virtual channels. Presentations represented a variety of approaches, including drug, biological, and device-based therapeutics. This summary provides high-level summaries of the trials presented and the resulting discussions including lessons learned. Rather than recapitulating published data, the presentations and discussions emphasized the novelty and strengths of each trial, practical aspects of translation, and lessons learned. Throughout the day, several discussion themes surfaced. These included reflections on the suitability of outcome measures and the distinction between statistically or clinically meaningful effects and meaningful changes in quality of life. Additional topics included novel trial designs, selection of inclusion criteria, recognizing the indispensable role of rehabilitation, tailoring approaches to individual needs, the importance of integrating lived experience, and emphasizing the importance of establishing robust pre-clinical data packages before venturing into clinical translation. Importantly, strategic directives are summarized to address these challenges, focusing resources and efforts to steer forthcoming trials effectively.</p>","PeriodicalId":74300,"journal":{"name":"Neurotrauma reports","volume":"6 1","pages":"210-231"},"PeriodicalIF":1.8000,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12040541/pdf/","citationCount":"0","resultStr":"{\"title\":\"Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update.\",\"authors\":\"Bethany R Kondiles, Sabhya Rana, David Weiner, Armin Blesch, James St John, Cornelia Haag-Molkenteller, Patrick Freund, James Guest, Daniel D Mikol, Susan Harkema, Randy D Trumbower, Michael G Fehlings, Norbert Weidner, Gary S Hogge, Edelle C Field-Fote, Marco A S Baptista, Armin Curt, Jane Hsieh, Linda Jones\",\"doi\":\"10.1089/neur.2024.0163\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The Spinal Cord Outcomes Partnership Endeavors presented a clinical trials update (CTU) in collaboration with the International Spinal Research Trust as a precourse to their annual meeting. Selected trials adhered to <i>a priori</i> considerations, prioritizing novelty and a focus on neurorestorative approaches. The sessions featured 13 speakers, covering 4 in-preparation, 4 in-progress, and 4 recently completed trials. In addition to in-person attendance, individuals worldwide viewed a live stream of the presentations. Approximately 1600 participants, comprising clinicians, researchers, industry stakeholders, foundations, and individuals with lived experiences, engaged in the CTU through both in-person and virtual channels. Presentations represented a variety of approaches, including drug, biological, and device-based therapeutics. This summary provides high-level summaries of the trials presented and the resulting discussions including lessons learned. Rather than recapitulating published data, the presentations and discussions emphasized the novelty and strengths of each trial, practical aspects of translation, and lessons learned. Throughout the day, several discussion themes surfaced. These included reflections on the suitability of outcome measures and the distinction between statistically or clinically meaningful effects and meaningful changes in quality of life. Additional topics included novel trial designs, selection of inclusion criteria, recognizing the indispensable role of rehabilitation, tailoring approaches to individual needs, the importance of integrating lived experience, and emphasizing the importance of establishing robust pre-clinical data packages before venturing into clinical translation. Importantly, strategic directives are summarized to address these challenges, focusing resources and efforts to steer forthcoming trials effectively.</p>\",\"PeriodicalId\":74300,\"journal\":{\"name\":\"Neurotrauma reports\",\"volume\":\"6 1\",\"pages\":\"210-231\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-03-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12040541/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neurotrauma reports\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1089/neur.2024.0163\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurotrauma reports","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1089/neur.2024.0163","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0

摘要

脊髓结局合作伙伴努力与国际脊柱研究信托基金会合作,在其年度会议前提交了一份临床试验更新(CTU)。选定的试验坚持先验考虑,优先考虑新颖性和关注神经修复方法。会议共有13位发言人,包括4个正在准备的试验、4个正在进行的试验和4个最近完成的试验。除了亲自出席,世界各地的个人还观看了演示的直播。大约1600名参与者,包括临床医生、研究人员、行业利益相关者、基金会和有实际经验的个人,通过面对面和虚拟渠道参与了CTU。介绍了各种方法,包括药物、生物和基于设备的治疗方法。本摘要提供了所提出的试验和由此产生的讨论的高级摘要,包括吸取的教训。演讲和讨论不是重述已发表的数据,而是强调每个试验的新颖性和优势,翻译的实际方面以及吸取的教训。一整天,几个讨论主题浮出水面。这些包括对结果测量的适用性的反思,以及统计或临床有意义的效果与生活质量有意义的变化之间的区别。其他主题包括新颖的试验设计、纳入标准的选择、认识到康复不可或缺的作用、针对个人需求量身定制的方法、整合生活经验的重要性,以及强调在冒险进入临床翻译之前建立健全的临床前数据包的重要性。重要的是,总结了应对这些挑战的战略指令,集中资源和努力有效地指导即将进行的试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update.

The Spinal Cord Outcomes Partnership Endeavors presented a clinical trials update (CTU) in collaboration with the International Spinal Research Trust as a precourse to their annual meeting. Selected trials adhered to a priori considerations, prioritizing novelty and a focus on neurorestorative approaches. The sessions featured 13 speakers, covering 4 in-preparation, 4 in-progress, and 4 recently completed trials. In addition to in-person attendance, individuals worldwide viewed a live stream of the presentations. Approximately 1600 participants, comprising clinicians, researchers, industry stakeholders, foundations, and individuals with lived experiences, engaged in the CTU through both in-person and virtual channels. Presentations represented a variety of approaches, including drug, biological, and device-based therapeutics. This summary provides high-level summaries of the trials presented and the resulting discussions including lessons learned. Rather than recapitulating published data, the presentations and discussions emphasized the novelty and strengths of each trial, practical aspects of translation, and lessons learned. Throughout the day, several discussion themes surfaced. These included reflections on the suitability of outcome measures and the distinction between statistically or clinically meaningful effects and meaningful changes in quality of life. Additional topics included novel trial designs, selection of inclusion criteria, recognizing the indispensable role of rehabilitation, tailoring approaches to individual needs, the importance of integrating lived experience, and emphasizing the importance of establishing robust pre-clinical data packages before venturing into clinical translation. Importantly, strategic directives are summarized to address these challenges, focusing resources and efforts to steer forthcoming trials effectively.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
2.40
自引率
0.00%
发文量
0
审稿时长
8 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信