Kondiles Bethany R, Rana Sabhya, Weiner David, Blesch Armin, St John James, Haag-Molkenteller Cornelia, Freund Patrick, Guest James, Mikol Daniel D, Harkema Susan, Trumbower Randy D, Fehlings Michael G, Weidner Norbert, Hogge Gary S, Field-Fote Edelle C, Baptista Marco A S, Curt Armin, Hsieh Jane, Jones Linda
International Collaboration on Repair Discoveries, Department of Zoology, University of British Columbia, Vancouver, Canada.
Department of Physical Therapy, University of Florida, Gainesville, Florida, USA.
Neurotrauma Rep. 2025 Mar 5;6(1):210-231. doi: 10.1089/neur.2024.0163. eCollection 2025.
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 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.
脊髓损伤预后合作项目（The Spinal Cord Outcomes Partnership Endeavors）与国际脊髓研究信托基金（International Spinal Research Trust）合作，在其年会前举办了一场临床试验最新进展（CTU）活动。入选的试验遵循了相关考量，将新颖性和对神经修复方法的关注放在首位。会议环节有13位演讲者，涵盖4项筹备中的试验、4项进行中的试验和4项近期完成的试验。除了现场参会外，全球各地的个人还观看了演讲的直播。约1600名参与者，包括临床医生、研究人员、行业利益相关者、基金会以及有实际经历的个人，通过现场和虚拟渠道参与了此次临床试验最新进展活动。演讲展示了多种方法，包括基于药物、生物和设备的疗法。本总结提供了所展示试验的高层次概述以及由此产生的讨论内容，包括经验教训。演讲和讨论强调的不是重复已发表的数据，而是每项试验的新颖性和优势、转化的实际方面以及经验教训。一整天出现了几个讨论主题。其中包括对结果测量指标适用性的思考，以及统计学或临床意义上的效果与生活质量有意义变化之间的区别。其他主题包括新颖的试验设计、纳入标准的选择、认识到康复的不可或缺作用、根据个体需求调整方法、整合实际经历的重要性，以及强调在进入临床转化之前建立强大的临床前数据包的重要性。重要的是，总结了战略指导方针以应对这些挑战，集中资源和努力以有效指导未来的试验。
