关于药物临床试验中妊娠检测的若干思考

Some opinion of pregnancy test in the drug clinical trial

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。

During the screening process,the women at childbearing age have to take the pregnancy test in order to avoid the harm of some new drugs for fetal or neonatal. However in the clinical process,some researchers have doubts,for example,if it is necessary for all the childbearing subjects to take a pregnancy test while some subjects do not or have no chance to get pregnant. Whether the regular urine pregnancy test that cannot indeed trace the source could reach the requirements of drug clinical trials＇ verification？ In most clinical protocols,there is such a brief description like pregnancy or lactation women,is it rigid？ Therefore,we put forward our own opinion and suggestion after investigating relevant laws,regulation and literature and combining the pregnancy description of 92 drugs clinical trial protocols. We suggest that the childbearing age women who do not or have no chance to get pregnant by asking the medical history do not take the pregnancy test. In the exclusion standard we should describe all the situation of pregnant in detail including the requirement and limitation for mail. What＇s more,it is also important to strengthen the education of the subjects and pay special attention on the subjects who will get pregnant in a short period for protecting their right and finishing the experiment.