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
Yagiz Ugur Yolcu1
Waseem Wahood2
Jad Zreik1
Sandy Goncalves1
Anthony John Windebank3
Wenchun Qu4
Mohamad Bydon1
1.Mayo Clinic Neuro-Informatics Laboratory,Mayo Clinic,Rochester,MN,USA;Department of Neurologic Surgery,Mayo Clinic,Rochester,MN,USA2.Mayo Clinic Neuro-Informatics Laboratory,Mayo Clinic,Rochester,MN,USA;Department of Neurologic Surgery,Mayo Clinic,Rochester,MN,USA;Dr.Kiran C.Patel College of Allopathic Medicine,Nova Southeastern University,Davie,FL,USA3.Department of Neurology,Mayo Clinic,Rochester,MN,USA4.Department of Physical Medicine&Rehabilitation,Mayo Clinic,Rochester,MN,USA
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 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.
机标关键词：
论文发表日期：2022-05-28
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）
页数：6( 953-958 )
英文信息