临床试验中妊娠事件的预防与处理

摘要

临床试验中由于试验药物或医疗器械安全性及有效性的不确定性,可能给受试者带来一定风险,如果在临床试验中发生妊娠无疑增加了风险.目前,妊娠事件多作为一种不良事件进行记录和报告,由于其性质的特殊性,与其他不良事件共同记录和处理并不恰当.妊娠事件除了关乎受试者的利益及其可能面临的风险,还关乎受试者的配偶及其后代的利益和风险.为了更好地处理妊娠事件,从试验设计、知情同意及试验展开三个方面,根据试验的目的 ,阐述了研究者、申办方、受试者各方应该承担的责任,使受试者的利益得到更充分的保护.%The uncertain safety and effectiveness of test drugs and medical instruments in clinical trials might pose risks to the subjects, and pregnancy events emerging in clinical trials will increase the risks. At present, most of pregnancy events are recorded and reported as an adverse event, but due to their particularity, it is inappropriate to record and handle them with other adverse events. Pregnancy event closely is related to the interests of the sub-jects and the risk it might face, besides, it is also related to the interest and risk of their spouses and offspring. In order to handle pregnancy event, this paper elaborated responsibilities of researchers, sponsors and subjects accord-ing to the purpose of trials in three aspects, including experiment design, informed consent, and test expand, so that the interest of the subjects could get better protection.