CAJ | 학술논문

本文为新药临床试验风险管理提供参考。在临床试验方案中引入风险管理方法，从风险管理的基本程序：风险识别、风险评估、风险控制等方面展开论证。充分认识和把握临床试验方案中存在的风险因素：临床前研究资料不足的风险、入选与排除标准制订的风险、有效性与安全性评价的风险、统计设计的风险、研究者和受试者依从性的风险等。根据风险性质的不同，可采用风险减轻、风险规避、风险转移、风险接受等控制措施，以有效减少后期临床试验过程中风险发生和降低损失。
본문위신약림상시험풍험관리제공삼고。재림상시험방안중인입풍험관리방법，종풍험관리적기본정서：풍험식별、풍험평고、풍험공제등방면전개론증。충분인식화파악림상시험방안중존재적풍험인소：림상전연구자료불족적풍험、입선여배제표준제정적풍험、유효성여안전성평개적풍험、통계설계적풍험、연구자화수시자의종성적풍험등。근거풍험성질적불동，가채용풍험감경、풍험규피、풍험전이、풍험접수등공제조시，이유효감소후기림상시험과정중풍험발생화강저손실。
Objective: To provide a reference for risk management of clinical trials. Methods: Risk management approaches were introduced in the design of clinical trial protocols, including the identification, assessment and intervention of risks. Results and Conclusion: Clinical trial protocol risks are mainly: lack of pre -clinical research materials, inclusion and exclusion criteria formulation, efficacy and safety evaluation, statistical design, the compliance of investigators and subjects. Depending on the nature of the risks, using risk reduction, risk avoidance, risk transfer, risk acceptance, the risks and losses of clinical trials can be effectively reduced in late-stage.