Article(id=1199703588063773108, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1199703581889753882, articleNumber=1001-2495(2025)01-0100-05, orderNo=null, doi=10.11669/cpj.2025.01.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1710259200000, receivedDateStr=2024-03-13, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1763961224809, onlineDateStr=2025-11-24, pubDate=1736265600000, pubDateStr=2025-01-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763961224809, onlineIssueDateStr=2025-11-24, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1763961224809, creator=13701087609, updateTime=1763961224809, updator=13701087609, issue=Issue{id=1199703581889753882, tenantId=1146029695717560320, journalId=1190317699101192196, year='2025', volume='60', issue='1', pageStart='1', pageEnd='104', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=0, articleOrder=1, issueType=-1, specialIssue=null, createTime=1763961223337, creator=13701087609, updateTime=1763967062652, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1199728073798157161, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1199703581889753882, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1199728073798157162, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1199703581889753882, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=100, endPage=104, ext={EN=ArticleExt(id=1199703588336402882, articleId=1199703588063773108, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Practice and Reflections on Investigator-Initiated Trial Approval Management with a Focus on Risk Prevention and Control, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To explore investigator-initiated trial(IIT) approval management with a focus on risk prevention and control in the absence of guidelines for IIT approval management. METHODS Through a combination of literature review and practical experiences, this study analyzed the challenges encountered in the approval process and explored its potential risks, outlined the approval process following the promulgation of the management regulations, summarized its key aspects, and assessed the significance of the approval process with a focus on risk prevention and control.RESULTS There exist inherent risks in areas such as research design, participant protection, research team dynamics, and research funding. The authors advocate for the implementation of compliance review, peer expert evaluation, and a hierarchical approval review by expert technical committee, emphasizing scrutiny of scientific validity, feasibility, and funding adequacy. CONCLUSION The proactive identification and prevention of potential risks are highlighted as crucial benefits of the approval management. Centralized management of IIT projects, development of data management platforms, and diversification of funding channels to enhance risk mitigation should be further explored.

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目的 在缺乏研究者发起的临床研究(investigator-initiated trials, IIT)管理规范的情况下,探讨基于风险防控的IIT立项管理。方法 通过文献调查结合工作实践,分析IIT立项审核发现的问题及其潜在风险,梳理《医疗卫生机构开展研究者发起的临床研究管理办法》颁布后的立项审核流程,总结立项审核要点,分析基于风险防控的立项审核的意义。结果 IIT项目立项阶段在项目的研究设计、受试者保护、研究团队及研究经费4个方面存在诸多风险。基于风险防控实施合规性审查、同行专家评议和专家技术委员会的层级化立项审核;针对科学性、可行性审核要点和研究经费能否保障的重点审核,有助于IIT项目尽早识别潜在风险并予以防范。结论 基于风险防控的立项管理对IIT项目潜在的风险起到了规避效应,有助于项目实施。IIT项目的中心化管理、数据管理平台建设和项目研究经费的多渠道保障对潜在风险的防范值得进一步探索。

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J Med Res(医学研究杂志), 2021, 50(6):6-9., articleTitle=Innovation drives the high-quality development of clinical medical research, refAbstract=null), Reference(id=1199727463908606646, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1199703588063773108, doi=null, pmid=null, pmcid=null, year=2023, volume=42, issue=12, pageStart=607, pageEnd=612, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=JIA S P, HUANG H Y, LENG Y, journalName=Chin J Cancer(癌症), refType=null, unstructuredReference=JIA S P, HUANG H Y, LENG Y, et al. The regulatory process and scientific challenges of international multi-center clinical trials in China[J]. 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立项过程	存在问题	潜在风险
研究设计
研究目的	拟要解决的临床问题不明确或简单重复前人研究,研究的必要性不充分	研究结果无意义或重复;损害受试者权益
研究方法	没有遵循现行指南,甚或没有经过最基本的文献查阅,盲目立项	研究方法不可靠;研究结果不可信
样本量计算	没有统计专业人员的参与	研究结果不可信
研究终点、入排标准	主要终点指标设计不合理,替代终点选择不合理;入排标准严苛	研究难以完成;容易造成方案违背
合并用药(治疗)的限制	没有对合并用药(治疗)加以限制或过于严苛	研究结果不可靠,或者违反伦理
数据管理	无电子化的管理系统,使用简单的Excel表格数据录入设计	数据的可溯源性、完整性、持久性难以保证
受试者保护
受试者招募和管理	招募计划未充分考虑受试者的地理位置;随访计划缺乏可操作性,无专人负责筛选及随访工作,忽视不良事件的随访	招募不能按计划完成;受试者脱落率增加;数据缺失率增加;研究结果偏移
受试者权益保护	知情同意书中未包含切实可行的受试者隐私权、知情权、补偿方式等权益条款	容易产生医患纠纷
研究安全性	安全性预判不足:方案中未正确描述AE、SAE的定义;未描述AE、SAE预期或非预期不良事件的发现、记录、分析处理和上报流程;对可预期的不良事件未进行描述并提供防范和救治预案	出现不良事件时导致AE漏记或误判;贻误受试者的救治时机,受试者安全利益无法保障;安全性相关研究结果不可靠
研究团队	部分研究人员未经过GCP相关培训;团队成员分工不合理	直接影响研究质量;影响试验产品管理和使用;影响研究数据的收集与管理
	项目所依托科室的综合情况无法满足项目开展情况	研究不能如期完成或被迫中止
研究经费	不能保证试验药品(器械)的免费提供、不能保证受试者必要检查的完成;受试者脱落比例高;因经费不足,让受试者或是医保承担部分检查费用;多数研究未购买保险	偏离研究方案;损害受试者权益,侵占医保资源;研究不能如期完成或研究中止;受试者和研究者均暴露于可能产生纠纷的风险之中

), ArticleFig(id=1199727460922262126, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1199703588063773108, language=CN, label=表1, caption=

在研究者发起临床研究(IIT)实施过程中立项阶段存在的11项问题和具体化潜在风险因素

, figureFileSmall=null, figureFileBig=null, tableContent=

立项过程	存在问题	潜在风险
研究设计
研究目的	拟要解决的临床问题不明确或简单重复前人研究,研究的必要性不充分	研究结果无意义或重复;损害受试者权益
研究方法	没有遵循现行指南,甚或没有经过最基本的文献查阅,盲目立项	研究方法不可靠;研究结果不可信
样本量计算	没有统计专业人员的参与	研究结果不可信
研究终点、入排标准	主要终点指标设计不合理,替代终点选择不合理;入排标准严苛	研究难以完成;容易造成方案违背
合并用药(治疗)的限制	没有对合并用药(治疗)加以限制或过于严苛	研究结果不可靠,或者违反伦理
数据管理	无电子化的管理系统,使用简单的Excel表格数据录入设计	数据的可溯源性、完整性、持久性难以保证
受试者保护
受试者招募和管理	招募计划未充分考虑受试者的地理位置;随访计划缺乏可操作性,无专人负责筛选及随访工作,忽视不良事件的随访	招募不能按计划完成;受试者脱落率增加;数据缺失率增加;研究结果偏移
受试者权益保护	知情同意书中未包含切实可行的受试者隐私权、知情权、补偿方式等权益条款	容易产生医患纠纷
研究安全性	安全性预判不足:方案中未正确描述AE、SAE的定义;未描述AE、SAE预期或非预期不良事件的发现、记录、分析处理和上报流程;对可预期的不良事件未进行描述并提供防范和救治预案	出现不良事件时导致AE漏记或误判;贻误受试者的救治时机,受试者安全利益无法保障;安全性相关研究结果不可靠
研究团队	部分研究人员未经过GCP相关培训;团队成员分工不合理	直接影响研究质量;影响试验产品管理和使用;影响研究数据的收集与管理
	项目所依托科室的综合情况无法满足项目开展情况	研究不能如期完成或被迫中止
研究经费	不能保证试验药品(器械)的免费提供、不能保证受试者必要检查的完成;受试者脱落比例高;因经费不足,让受试者或是医保承担部分检查费用;多数研究未购买保险	偏离研究方案;损害受试者权益,侵占医保资源;研究不能如期完成或研究中止;受试者和研究者均暴露于可能产生纠纷的风险之中

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