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

作     者：F M Moinuddin Yagiz Ugur Yolcu Waseem Wahood Jad Zreik Sandy Goncalves Anthony John Windebank Wenchun Qu Mohamad Bydon 

作者机构：Mayo Clinic Neuro-Informatics LaboratoryMayo ClinicRochesterMNUSA Department of Neurologic SurgeryMayo ClinicRochesterMNUSA Dr.Kiran C.Patel College of Allopathic MedicineNova Southeastern UniversityDavieFLUSA Department of NeurologyMayo ClinicRochesterMNUSA Department of Physical Medicine&RehabilitationMayo ClinicRochesterMNUSA 

出 版 物：《Neural Regeneration Research》 (中国神经再生研究（英文版）)

年 卷 期：2022年第17卷第5期

页      面：953-958页

核心收录：

学科分类：1002[医学-临床医学] 100210[医学-外科学(含：普外、骨外、泌尿外、胸心外、神外、整形、烧伤、野战外)] 10[医学] 

主　　题：chronic clinical trial spinal cord injury systematic review time-to-enrollment 

摘      要：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 ***,we sought to evaluate the impact of time-to-enrollment in chronic SCI clinical trials.A data set comprising 957 clinical studies from clinical *** was downloaded and analyzed focusing on the eligibility criteria for post-injury *** also aggregated individual patient data from nine clinical trials of regenerative interventions for chronic SCI selected by a systematic literature search from 1990 to *** 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 Clinical *** registry,445 trials were identified for chronic SCI where 87%(385)were unrestricted in the maximum post-injury time for trial *** systematic literature search,nine studies and 156 patients(group 1=30,group 2=55 and group 3=71)were *** range of time-to-enrollment was 0.5 to 321 months in those *** also observed various degrees of motor and sensory improvement in between three time-to-enrollment *** results indicate that enrolling wide ranges of time-to-enrollment in a group may present imprecise *** trial designs should consider appropriate postinjury time frames to evaluate therapeutic benefit.