关于药物临床试验中妊娠检测的若干思考

发布时间：2018-03-05 14:56

本文选题：药物临床试验　切入点：妊娠检测　出处：《中国临床药理学杂志》2017年07期 　论文类型：期刊论文

【摘要】：药物临床试验中由于新药对于胎儿或新生儿可能存在的安全隐患,在筛选过程中要求对所有育龄期女性进行妊娠检测。然而,在实际操作过程中,有研究者会提出一些疑问,当筛选的育龄期受试者明确告知其没有怀孕的可能性,是否依旧需要做妊娠检测?目前,普遍推行的尿妊娠检测不能溯源,是否满足药物临床试验核查要求?大部分试验方案仅在排除标准中简单描述为"妊娠或哺乳期妇女",这样是否严谨?为此,笔者查阅了相关法律法规和文献,结合92例药物临床试验方案中妊娠相关内容的描述,提出了自己的意见和建议,认为对于研究者问病史能够确定其没有怀孕或怀孕可能的育龄期女性可以免做妊娠检测;而方案排除标准中应当将妊娠涉及的情况进行全面描述,包括对男性受试者的要求和约束;此外,加强对入组受试者教育,重点关注短期受孕(或使配偶怀孕)可能性较大的受试者,对于保障其权益和试验的顺利完成也是十分重要的。
[Abstract]:In clinical trials, because of the potential safety risks of new drugs for fetuses or newborns, pregnancy testing is required for all women of childbearing age during screening. However, in practice, some researchers may ask questions. When the selected childbearing age subjects explicitly inform them of the possibility that they are not pregnant, do they still need to be tested for pregnancy? At present, the universal implementation of urine pregnancy testing can not trace to the source, whether to meet the requirements of drug clinical trials verification? Is it strict that most of the trial programmes are simply described as "pregnant or lactating women" in the exclusion criteria? Therefore, the author consulted the relevant laws and regulations and literature, combined with 92 cases of drug clinical trial program of pregnancy related content description, put forward their own opinions and suggestions. Believing that women of childbearing age who were not pregnant or likely to be pregnant could be exempted from pregnancy tests when asked about their medical history, and that the exclusion criteria for the scheme should provide a comprehensive description of the circumstances involved in pregnancy, Including requirements and constraints on male subjects; in addition, to strengthen education for the participants in the group, with a focus on subjects who are more likely to conceive for a short period of time (or make their spouse pregnant), It is also very important to ensure its rights and interests and the successful completion of the experiment.
【作者单位】：兰州军区兰州总医院国家药物临床试验机构;北京大学第一医院临床药理研究所;
【分类号】：R969

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