建立数据监查委员会对多中心临床试验的价值

随着我国多中心临床试验数量日益增多,为保护受试者的安全与研究数据的完整性,防止多中心临床试验过程发生偏倚,往往需要对临床试验进行独立和持续的监测。因此,有必要建立与之对应的数据监查委员会(Data Monitoring Committee,DMC)来负责这些任务。本文主要通过介绍DMC的组成、独立性、利益冲突、会议形式、审查研究进展、数据质量、安全性与有效性结果、在期中分析中的作用以及对试验数据的评价,探讨在多中心临床试验建立DMC的意义和价值。

我国临床试验中建立独立数据监查委员会的分析与探讨

独立数据监查委员会(IDMC)的设立对于临床研究受试者的安全性、数据的公正性有重要的意义,正成为临床试验中日益常见的部分。目前,我国临床试验中IDMC建立的合理性与规范性、实施的规范性、监管等方面尚面临挑战。本文通过查阅相关文献、法规、指导原则和国家药品监督管理局药品审评中心(CDE)药物临床试验登记与信息公示平台数据,了解其背景、职责、适用范围和各监管部门要求,分析和探讨我国临床试验中建立IDMC的现状与面临的挑战,基于相关法规要求提出建议,为我国临床试验IDMC的建立与监管提供参考。

临床试验数据与安全监查委员会发展现状与操作规程

临床试验数据与安全监查委员会（DSMB）是定期对临床研究累积数据进行分析与评价并提出建议的组织。其主要作用是确保研究的准确性和安全性…。DSMB的建立不仅能保护受试者的安全和利益，同时也能节约时间成本和资源。如何在临床试验中建立DSMB以及DSMB应该如何履行责任是临床研究所关心的问题。本研究介绍了DSMB的定义及发展，如何建立DSMB及DSMB与临床试验相关其他组织的区别。

数据监查委员会在新型冠状病毒肺炎疫情临床试验监管的应用和挑战

面对新型冠状病毒肺炎突发公共卫生事件,如何监管快速审评审批的临床试验是药品监管部门的职责,也是一个重要课题。申办者可通过建立数据监查委员会,在临床试验中对累积的安全性和有效性数据、试验实施情况进行监查,及时评估风险和效益,以保护受试者的安全和权益。本文通过研究数据监查委员会的历史、适用范围、职责等以及在新型冠状病毒肺炎疫情临床试验中应用的挑战和建议,以期为应对突发公共卫生事件加强临床试验监管提供参考依据。

临床研究数据与安全监查国际发展现状与思考

数据与安全监查委员会(Data and Safety Monitoring Board,DSMB)在国际范围内广泛应用于大规模、多中心临床试验及政府资助项目,它在全程保护受试者安全、提升临床研究质量与水平方面起着十分重要的作用。虽然DSMB在欧美发达国家运用经验较成熟,但在我国目前尚处于起步阶段。该文通过回顾DSMB的起源和工作流程,比较模式及国际现行各指导原则,分析其应用现状、发展趋势和存在的问题,提出根据各国国情及不同临床研究特点,除了对累积数据进行期中分析以动态评估干预措施的安全性有效性外,采取扩大监查范围、丰富监查模式、建立专业的技术队伍、制定符合各类临床研究特点的DSMB操作规程、重视并建立DSMB保险和赔偿机制等策略,不仅是在国际范围内推进和完善数据与安全监查工作的有效途径,也是提高我国临床研究技术与国际先进水平接轨亟待解决的问题。

临床试验安全性监查过程中统计学方法的应用

安全性评价是新药临床试验的重要组成部分。大规模试验中严重安全性问题的监查往往需要数据安全监查委员会的参与,以便及时发现安全性问题。试验开始之前应首先确定安全性界值,如果达到该界值则表明存在不可接受的安全性问题。本文主要阐述临床试验安全性评价中几种常用的确定安全性终止界值的统计学方法,旨在为国内新药研发和临床研究提供有益参考,帮助数据监查委员会更好的进行安全性评价。

Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup

AIM:To determine which patients might benefit most from retrograde viewing during colonoscopy through subset analysis of randomized,controlled trial data.METHODS:The Third Eye Retroscope Randomized Clinical Evaluation(TERRACE) was a randomized,controlled,multicenter trial designed to evaluate the efficacy of a retrograde-viewing auxiliary imaging device that is used during colonoscopy to provide a second video image which allows viewing of areas on the proximal aspect of haustral folds and flexures that are difficult to see with the colonoscope's forward view.We performed a post-hoc analysis of the TERRACE data to determine whether certain subsets of the patient population would gain more benefit than others from use of the device.Subjects were patients scheduled for colonoscopy for screening,surveillance or diagnostic workup,and each underwent same-day tandem examinations with standard colonoscopy(SC) and Third Eye colonoscopy(TEC),randomized to SC followed by TEC or vice versa.RESULTS:Indication for colonoscopy was screening in 176/345 subjects(51.0%),surveillance after previous polypectomy in 87(25.2%) and diagnostic workup in 82(23.8%).In 4 subjects no indication was specified.Previously reported overall results had shown a net additional adenoma detection rate(ADR) with TEC of 23.2% compared to SC.Relative risk(RR) of missing adenomas with SC vs TEC as the initial procedure was 1.92(P = 0.029).Post-hoc subset analysis shows additional ADRs for TEC compared to SC were 4.4% for screening,35.7% for surveillance,55.4% for diagnostic and 40.7% for surveillance and diagnostic combined.The RR of missing adenomas with SC vs TEC was 1.11(P = 0.815) for screening,3.15(P = 0.014) for surveillance,8.64(P = 0.039) for diagnostic and 3.34(P = 0.003) for surveillance and diagnostic combined.Although a multivariate Poisson regression suggested gender as a possibly significant factor,subset analysis showed that the difference between genders was not statistically significant.Age,bowel prep quality and withdrawal time did not significantly affect the RR of missing adenomas with SC vs TEC.Mean sizes of adenomas detected with TEC and SC were similar at 0.59 cm and 0.56 cm,respectively(P = NS).CONCLUSION:TEC allows detection of significantly more adenomas compared to SC in patients undergoing surveillance or diagnostic workup,but not in screening patients(ClinicalTrials.gov Identifier:NCT01044732).

Earthquake Damage Analysis of M_S 4.9 Earthquake at the Juncture of Gaoyou and Baoying, Jiangsu Province

Based on the network monitoring data and field investigations,the basic characteristics of the M S4.9 earthquake at the juncture of Gaoyou and Baoying in Jiangsu Province on July20,2012 have been introduced,and the focal mechanism solutions have also been obtained.According to the regional tectonic features and site macroscopic survey,the occurrence of the earthquake was probably related to the Yangchacang-Sangshutou fault.Based on site survey data,both the evaluation criterion of seismic intensity of this region and the seismic intensity maps have been proposed.According to the damage characteristics of brick-concrete structure and brick-wood structure,the main reasons of serious damage for buildings are poor foundation conditions,low seismic bearing capacity,poor quality of construction and disrepair.Considering the differences of earthquake damage in the different regions,advice on accelerating the new rural construction,improving the resistance against earthquake disasters of rural residential areas and strengthening the seismogenic research on strong and moderate size earthquake is proposed,which will be possibly helpful for earthquake damage survey,prediction and prevention.