■在临床试验中包括育龄妇女,因此有必要从生物伦理学的角度考虑两个因素:第一,缺乏关于研究产品潜在致畸作用的知识,而且,正义原则不排除任何人口从研究的利益。解决这个问题的最常见方法是要求志愿者在使用避孕药之前,during,在临床试验几周后.这项工作介绍了在阿尔茨海默病预防倡议常染色体显性阿尔茨海默病(APIADAD)哥伦比亚临床试验期间用于促进避孕使用和预防怀孕的所有策略。该试验的两个特征使其对密切监测避孕使用特别感兴趣。一是审判持续了7年多,另一个是参与者可能是E280APSEN1突变的携带者,早在30多岁时就导致轻度认知障碍。
■在筛查访视期间进行了一项单独的医学评估,以选择最适合志愿者的避孕方法,必要时交给妇科医生。所有非手术避孕方法均由申办方提供。工作人员接受了避孕咨询培训,向志愿者正确分配避孕药,和识别,reporting,并跟进怀孕。进行了两次关于避孕使用的全面教育运动,干预包括所有志愿者。此外,在一项年度调查中,我们要求志愿者评估配药程序.最后,这些策略的有效性进行了回顾性评估,通过外推法将整个试验期间出现的怀孕次数与哥伦比亚的一般生育率进行比较。
■共招募了159名女性志愿者。所有战略都按计划实施,即使在COVID-19应急期间。评估期间(2015-2021年)发生了10次怀孕。计划了两个;其余的与潜在的治疗失败或不正确使用避孕方法有关,每年避孕失败0.49%。百分之六十的怀孕导致堕胎,流产或治疗性流产。然而,没有足够的数据将妊娠结局与研究产品的给药相关联.最后,我们观察到,与哥伦比亚人群相比,参与试验的女性生育率较低.
在7年的评估中,与哥伦比亚人口相比,参与试验的妇女避孕失败的发生率较低,怀孕的发生率下降,这表明在APIADADColombia中使用的策略在解决避孕使用方面是充分和有效的。
UNASSIGNED: Including women of childbearing age in a clinical trial makes it necessary to consider two factors from a bioethical perspective: first, the lack of knowledge about the potential teratogenic effects of an investigational product, and also, the principle of justice not to exclude any population from the benefits of research. The most common way to address this issue is by requiring volunteers to use contraceptives before, during, and a few weeks after the clinical trial. This work presents all the strategies used to promote contraception use and prevent pregnancy during the Alzheimer\'s Prevention Initiative Autosomal-Dominant Alzheimer\'s Disease (API ADAD) Colombia clinical trial. Two characteristics of this trial make it of special interest for closely monitoring contraception use. One is that the trial lasted more than 7 years, and the other is that participants could be carriers of the E280A PSEN1 mutation, leading to a mild cognitive impairment as early as their late 30s.
UNASSIGNED: An individual medical evaluation to select the contraception method that best fits the volunteer was carried out during the screening visit, remitting to the gynecologist when necessary. All non-surgical contraception methods were supplied by the sponsor. Staff were trained on contraception counseling, correctly dispensing contraceptive drugs to volunteers, and identifying, reporting, and following up on pregnancies. Two comprehensive educational campaigns on contraception use were performed, and the intervention included all volunteers. In addition, volunteers were asked on an annual survey to evaluate the dispensing procedure. Finally, the effectiveness of these strategies was retrospectively evaluated, comparing by extrapolation the number of pregnancies presented throughout the trial with the General Fertility Rate in Colombia.
UNASSIGNED: A total of 159 female volunteers were recruited. All strategies were implemented as planned, even during the COVID-19 contingency. Ten pregnancies occurred during the evaluation period (2015-2021). Two were planned; the rest were associated with a potential therapeutic failure or incorrect use of contraceptive methods for a contraceptive failure of 0.49% per year. Sixty percent of pregnancies led to an abortion, either miscarriage or therapeutic abortion. However, there was not enough data to associate the pregnancy outcome with the administration of the investigational product. Finally, we observed a lower fertility rate in women participating in the trial compared to the Colombian population.
UNASSIGNED: The lower rates of contraceptive failure and the decrease in the incidence of pregnancies in women participating in the trial compared to the Colombian population across the 7 years of evaluation suggest that the strategies used in API ADAD Colombia were adequate and effective in addressing contraception use.