Unité de vigilance des essais cliniques, Service de Pharmacologie-Toxicologie et Pharmacovigilance, CHU de Limoges, Limoges, France.
Unité de vigilance des essais cliniques, Centre Hospitalier Universitaire de Nantes, Nantes, France.
Clin Trials. 2020 Jun;17(3):314-322. doi: 10.1177/1740774520903720. Epub 2020 Feb 6.
BACKGROUND/AIMS: The Clinical Trials Coordination and Facilitation Group has issued recommendations on contraception and pregnancy testing to help sponsors meet regulatory expectations and harmonize practices to limit embryofetal risks in clinical trials. Our objective was to assess the compliance of French academic clinical trials with these recommendations and to describe the mitigation measures required by sponsors in their trials.
A cross-sectional study was performed on the French academic drug trials authorized by the national competent authority between January 2015 and June 2018. We included trials which tested systemic administration of drugs and enrolled men or women of childbearing potential.
Data from 97 trials included were compiled. One-third of the trials (23.8%-43.3%, 95% confidence interval) complied with the Clinical Trial Facilitation and Coordination Group recommendations. No improvement over time or according to embryofetotoxic status or drug duration exposure was found. Contraception was required in 56.7% of trials and was more often required in case of potentially embryofetotoxic drugs (68.5% vs 41.9%, p = 0.013) or exposure over 1 month (71.7% vs 43.8%, p = 0.006). Pregnancy testing at inclusion was required in 59.1% of trials and additional testing in 17.2%. Pregnancy testing at inclusion was more often required in trials with drug exposure above 1 month (67.4% vs 45.8%, p = 0.035).
French academic sponsors barely met the recommendations on contraception and pregnancy testing potentially leading to potential embryofetal risks in case of pregnancy. They need to implement these recommendations quickly.
背景/目的：临床试验协调与促进小组发布了关于避孕和妊娠检测的建议，以帮助申办方满足监管期望并协调实践，从而限制临床试验中的胚胎胎儿风险。我们的目的是评估法国学术性临床试验对这些建议的遵守情况，并描述申办方在其试验中需要采取的缓解措施。
对 2015 年 1 月至 2018 年 6 月期间经国家主管部门授权的法国学术性药物试验进行了一项横断面研究。我们纳入了测试全身给药且招募有生育潜力的男性或女性的试验。
共整理了 97 项试验的数据。三分之一（95%置信区间：23.8%-43.3%）的试验符合临床试验协调与促进小组的建议。未发现随着时间的推移或根据胚胎胎儿毒性状态或药物暴露时间的不同而有所改善。56.7%的试验需要避孕，而在潜在胚胎胎儿毒性药物（68.5% vs 41.9%，p=0.013）或暴露时间超过 1 个月（71.7% vs 43.8%，p=0.006）的情况下，避孕的要求更为常见。59.1%的试验需要在纳入时进行妊娠检测，17.2%的试验需要额外的检测。在药物暴露时间超过 1 个月的试验中，更常需要进行纳入时的妊娠检测（67.4% vs 45.8%，p=0.035）。
法国学术性申办方几乎没有遵守避孕和妊娠检测的建议，这可能导致妊娠时潜在的胚胎胎儿风险。他们需要迅速落实这些建议。
