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论文编号：	15918
作者编号：	2320233985
上传时间：	2025/12/12 23:42:05
中文题目：	F公司W去中心化临床试验项目质量风险管理研究
英文题目：	Research on Risk Management for W Decentralized Clinical Trials (DCT) Project of F Company
指导老师：	程莉莉副教授
中文关键字：	去中心化临床试验；医药研发；质量风险管理；层次分析法
英文关键字：	Decentralized Clinical Trials (DCT); Pharmaceutical R&D; Quality Risk Management; Analytic Hierarchy Process (AHP)
中文摘要：	中国近年来新药研发呈现爆发式增长，从政策支持、审批提速到国际化突破，整体产业已从“跟随仿制”迈入“全球领跑”阶段。临床试验数量的持续增长为临床试验项目的运营带来巨大挑战。传统临床试验项目成本高，对受试者也有很大负担。为解决这一问题，去中心化临床试验（DCT）应运而生。然而由于去中心化临床试验既往研究较少，并且以受试者为中心，在实施前企业必须着重思考如何有效规避或者减轻该类临床试验风险，保证临床试验质量。 新药研发能力是医药企业的核心竞争力，对其开展风险管理有助于保证临床试验质量，增加药物上市成功率。临床试验作为新药研发的核心阶段，其风险类型复杂多样。本研究围绕质量风险层面，针对F公司实施的W分布式临床试验展开探究。 运用结构化问卷来收集质量风险项目，以风险清单法构建F公司W去中心化临床试验质量影响因素清单，涵盖方案策划、试验用药、临床执行进程和研究团队管理等质量风险点，接着采用风险矩阵法，从风险触发可能性和严重性两个维度量化子项风险等级，针对高风险因素采用德尔菲法与层次分析法相结合的办法建立评价模型，明确其先后次序，进而聚焦关键质量风险环节，在此基础上，研究围绕W去中心化临床试验的核心风险指标展开分析。制定应对策略与监控机制，以实现对质量风险的有效控制，提升试验质量。 本文系统的分析了W去中心化临床试验的研究设计和研究流程，继而辨别出关键的质量潜在风险，再落实应对办法和监控措施。这将有助于提高W去中心化临床试验的质量，继而提高W去中心化临床试验的成功率，并为中国乃至全世界的DCT临床试验的质量风险管理供参考。
英文摘要：	In recent years, China has an explosive growth in new drug development. With supportive policies, accelerated regulatory reviews, and breakthroughs in internationalization, the industry as a whole has transitioned from a “follow-on imitation” model to a “global leadership” stage. The continuous increase in clinical trial activities has posed significant operational challenges. Traditional clinical trials are often associated with high costs and substantial burdens on participants. To address these issues, Decentralized Clinical Trials (DCT) have emerged. However, due to the relatively limited previous research on DCT and its patient centered nature, companies must carefully consider how to effectively avoid or mitigate risks in such trials to ensure quality. The capability for new drug development is the core competitiveness of pharmaceutical companies. Conducting risk management in this process helps ensure the quality of clinical trials and enhances the success rate of drug approvals. As the central stage of new drug development, clinical trials involve diverse and complex risk types. From a quality risk perspective, this study takes F Company’s DCT project was an example. First, a questionnaire was used to collect quality risk factors, and Risk Checklist Method was applied to establish a quality risk factor list affecting the DCT project W, encompassing risks inherent in protocol design, investigational product quality, clinical trial implementation processes, and the management of project teams and site personnel. Subsequently, a risk matrix was employed to assess the risk level of each sub-factor based on the dimensions of probability and severity. For high-risk factors, an evaluation model was constructed using Delphi Method and the Analytic Hierarchy Process (AHP) to determine their relative importance, thereby identifying key quality risk sub-factors. Based on these, tailored response strategies and monitoring mechanisms were developed according to the specific characteristics of the key risks in the DCT project W, aiming to achieve effective quality risk control and enhance trial quality. This study systematically analyzes the research design and workflow of the DCT project W to identify critical quality risk factors, and proposes corresponding mitigation and monitoring measures. These findings will help enhance the quality of the DCT project W, thereby improving their success rate, and provide a reference for quality risk management in DCTs both in China and globally.
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