中国神经再生研究(英文版) ›› 2022, Vol. 17 ›› Issue (5): 953-958.doi: 10.4103/1673-5374.324826

• 综述:脊髓损伤修复保护与再生 • 上一篇    下一篇

研究慢性脊髓损伤神经功能恢复临床试验入组时间:来自系统综述和北美数据库的结果

  

  • 出版日期:2022-05-15 发布日期:2021-11-08

Time-to-enrollment in clinical trials investigating neurological recovery in chronic spinal cord injury: observations from a systematic review and ClinicalTrials.gov database

F M Moinuddin1, 2, Yagiz Ugur Yolcu1, 2, Waseem Wahood1, 2, 3, Jad Zreik1, 2, Sandy Goncalves1, 2, Anthony John Windebank4, Wenchun Qu5, Mohamad Bydon1, 2, *   

  1. 1Mayo Clinic Neuro-Informatics Laboratory, Mayo Clinic, Rochester, MN, USA; 2Department of Neurologic Surgery, Mayo Clinic, Rochester, MN, USA; 3Dr. Kiran C. Patel College of Allopathic Medicine, Nova Southeastern University, Davie, FL, USA; 4Department of Neurology, Mayo Clinic, Rochester, MN, USA; 5Department of Physical Medicine & Rehabilitation, Mayo Clinic, Rochester, MN, USA
  • Online:2022-05-15 Published:2021-11-08
  • Contact: Mohamad Bydon, MD, bydon.mohamad@mayo.edu.

摘要: Neural Regen Res  试验研究入组时间与慢性脊髓损伤修复结局的关系: 基于系统综述和北美数据库的结果
目前已有大量临床试验探讨了不同的试验方法在慢性脊髓损伤(SCI)患者中的作用。然而,在试验入组登记过程中,对于如何确定SCI和干预之间的时间段有不同的看法。来自美国梅奥诊所神经信息学实验室的Mohamad Bydonji及其团队评估了慢性SCI患者临床试验入组时间对神经功能恢复的影响。他们从美国临床试验数据库下载了957项临床研究数据,并从系统综述中收集了9项慢性SCI再生干预临床试验的个体患者数据。经过分析比较发现,试验入组时间与慢性脊髓损伤患者感觉和运动功能的改善关系密切,试验入组时间范围广泛可能会导致试验结果不精确。临床试验设计应考虑适当的伤后时间框架来评估治疗效果。

文章在《中国神经再生研究(英文版)》杂志2021年5月5期发表。

https://orcid.org/0000-0002-0543-396X (Mohamad Bydon) 

Abstract: Currently, large numbers of clinical trials are performed to investigate different forms of experimental therapy for patients suffering from chronic spinal cord injury (SCI). However, for the enrollment process, there are different views on how the time period between injury and interventions should be determined. Herein, we sought to evaluate the impact of time-to-enrollment in chronic SCI clinical trials. A data set comprising 957 clinical studies from clinicalTrials.gov was downloaded and analyzed focusing on the eligibility criteria for post-injury time-to-enrollment. We also aggregated individual patient data from nine clinical trials of regenerative interventions for chronic SCI selected by a systematic literature search from 1990 to 2018. Characteristics of the studies were assessed and compared by dividing into three groups based on time-to-enrollment (group 1 ≤ 12 months, group 2 = 12–23 months and group 3 ≥ 24 months). In ClinicalTrials.gov registry, 445 trials were identified for chronic SCI where 87% (385) were unrestricted in the maximum post-injury time for trial eligibility. From systematic literature search, nine studies and 156 patients (group 1 = 30, group 2 = 55 and group 3 = 71) were included. The range of time-to-enrollment was 0.5 to 321 months in those studies. We also observed various degrees of motor and sensory improvement in between three time-to-enrollment groups. Our results indicate that enrolling wide ranges of time-to-enrollment in a group may present imprecise outcomes. Clinical trial designs should consider appropriate post-injury time frames to evaluate therapeutic benefit. 

Key words: chronic, clinical trial, spinal cord injury, systematic review, time-to-enrollment