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 ...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 clinical Trials.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 Clinical Trials.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 postinjury time frames to evaluate therapeutic benefit.展开更多
目的分析美国陆军医学研究与物资部(U.S. Army Medical Research and Materiel Command,USAMRMC)临床试验特点,了解美国军队军事医学研究的主要动向。方法通过ClinicalTrials.gov数据库检索USAMRMC发起或参与完成的临床试验,从主题词、...目的分析美国陆军医学研究与物资部(U.S. Army Medical Research and Materiel Command,USAMRMC)临床试验特点,了解美国军队军事医学研究的主要动向。方法通过ClinicalTrials.gov数据库检索USAMRMC发起或参与完成的临床试验,从主题词、研究内容、进展状态、临床分期、任务分配及地域分布等方面对临床试验项目进行统计和分析。结果 USAMRMC主要关注于感染性疾病、创伤及神经系统疾病的临床试验,并在上述疾病的疫苗、药物和医疗器械研发中投入大量研究力量。其主导或参与的临床试验中约57.7%已完成并公布研究结果,77.9%在美国本土组织开展,43.1%由美国军队医学机构直接参与。结论 USAMRMC主要依托美国本土力量,通过高效的军地协作机制,在战场传染病防治、战伤救治等的基础和临床研究方面开展了大量工作;启示我国军事医学研究要高度重视地域性疾病防治,强化关键核心技术的协同创新。展开更多
目的 了解美国军队野战输血医学发展的主要方向和最新动态。方法 通过www.clinicaltrials.gov网站首页,以“United States Department of Defense”“U.S.Army Medical Research and Development Command”“United States Naval Medica...目的 了解美国军队野战输血医学发展的主要方向和最新动态。方法 通过www.clinicaltrials.gov网站首页,以“United States Department of Defense”“U.S.Army Medical Research and Development Command”“United States Naval Medical Research Center”为检索词,检索自ClinicalTrials.gov成立(2002年)起至2021年5月1日野战输血医学相关临床试验项目的完整备案信息,通过研究进展状态、临床分期、任务分配、地域分布和主要研究内容及研究成果等,分析其主要特点。结果 共检索到临床试验项目931项,与野战输血医学密切相关的有16项;其中全血病原体处置占25%(4/16)、血小板输注占25%(4/16)、血浆输注占25%(4/16)、全血输注占18.75(3/16)和其他类型研究占6.25%(1/16)。美国军方注重在血液安全、血液贮存等方面的新技术突破,在抗休克输血输液治疗方面的效果评价,在全血早期输注治疗方面的应用探索和在血液保障技术产品研发方面的军地互动优势。结论 基于ClinicalTrials.gov对美国军方野战输血医学的分析,有利于快速了解美国军队野战输血医学的发展现状和趋势。展开更多
文摘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 clinical Trials.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 Clinical Trials.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 postinjury time frames to evaluate therapeutic benefit.
文摘目的分析美国陆军医学研究与物资部(U.S. Army Medical Research and Materiel Command,USAMRMC)临床试验特点,了解美国军队军事医学研究的主要动向。方法通过ClinicalTrials.gov数据库检索USAMRMC发起或参与完成的临床试验,从主题词、研究内容、进展状态、临床分期、任务分配及地域分布等方面对临床试验项目进行统计和分析。结果 USAMRMC主要关注于感染性疾病、创伤及神经系统疾病的临床试验,并在上述疾病的疫苗、药物和医疗器械研发中投入大量研究力量。其主导或参与的临床试验中约57.7%已完成并公布研究结果,77.9%在美国本土组织开展,43.1%由美国军队医学机构直接参与。结论 USAMRMC主要依托美国本土力量,通过高效的军地协作机制,在战场传染病防治、战伤救治等的基础和临床研究方面开展了大量工作;启示我国军事医学研究要高度重视地域性疾病防治,强化关键核心技术的协同创新。
文摘目的 了解美国军队野战输血医学发展的主要方向和最新动态。方法 通过www.clinicaltrials.gov网站首页,以“United States Department of Defense”“U.S.Army Medical Research and Development Command”“United States Naval Medical Research Center”为检索词,检索自ClinicalTrials.gov成立(2002年)起至2021年5月1日野战输血医学相关临床试验项目的完整备案信息,通过研究进展状态、临床分期、任务分配、地域分布和主要研究内容及研究成果等,分析其主要特点。结果 共检索到临床试验项目931项,与野战输血医学密切相关的有16项;其中全血病原体处置占25%(4/16)、血小板输注占25%(4/16)、血浆输注占25%(4/16)、全血输注占18.75(3/16)和其他类型研究占6.25%(1/16)。美国军方注重在血液安全、血液贮存等方面的新技术突破,在抗休克输血输液治疗方面的效果评价,在全血早期输注治疗方面的应用探索和在血液保障技术产品研发方面的军地互动优势。结论 基于ClinicalTrials.gov对美国军方野战输血医学的分析,有利于快速了解美国军队野战输血医学的发展现状和趋势。
