药师参与肿瘤患者新药临床试验伦理审查典型案例分析

目的：探讨肿瘤患者新药临床试验中各种伦理问题的具体表现形式，为提高医疗机构伦理审查的质量和水平提供参考。方法：通过分析14例肿瘤患者新药临床试验典型案例，找出存在的伦理问题。结果：研究方案存在研究基础不充分、纳入排除标准不严谨、对照组设置不合理、揭盲时间不合理等问题；知情同意书存在告知信息不充分、语言表述不准确、补偿与支付方式不合理等问题；修正案存在超范围修改等问题。结论：肿瘤患者新药临床试验中伦理风险表现形式多样，药师通过参与伦理审查，提高了伦理审查质量，保护了受试者权益。

A typical case study of pharmacist participating in ethical review of new drug clinical trials in cancer patients

OBJECTIVE To explore the specific manifestations of various ethical problems in clinical trials of new antitumor drugs and provide reference for improving the quality and level of ethical review in medical institutions.METHODS Through the analysis of 14 typical cases of clinical trials of new drugs for cancer patients, existing ethical problems were identified.RESULTS Some problems persisted in research protocols, such as insufficient research basis, lax inclusion and exclusion criteria, unreasonable setting of control group and unreasonable time for unblinding. Informed consent remained problematic, such as insufficient information, inaccurate language expression and unreasonable compensation and payment methods. There were some problems in amendment, such as exceeding the scope of amendment.CONCLUSION In clinical trials of new drugs for cancer patients, ethical risks are manifested in various forms. By participating in ethical review, pharmacist can boost the quality of ethical review and protect the rights and interests of subjects.