Franceschini Robert, Wicks Sarah L
BluePath Health, 80 E Sir Francis Drake Blvd, Suite 4H Larkspur, CA 94939 USA.
Goodwin Procter LLP, 1900 N Street NW, Washington, DC, 20036, USA.
Contemp Clin Trials Commun. 2022 Jan 20;26:100890. doi: 10.1016/j.conctc.2022.100890. eCollection 2022 Apr.
The common exclusion of pregnant women from clinical HIV research warrants inquiry into those few studies that do include pregnant women. This commentary highlights some of the pitfalls of the ClinicalTrials.gov platform for its intended users--study participants, particularly pregnant women--and investigators looking to use its data for study. Some of the pitfalls include missing information; lack of historical reporting enforcement; difficulty searching for studies focused on pregnant women versus the fetus; inability to consistently find studies targeted at specific stages of pregnancy; and lack of information relating to whether a study intervention is investigational or previously approved by the FDA.
临床HIV研究通常将孕妇排除在外，因此有必要对少数纳入孕妇的研究进行调查。本评论强调了ClinicalTrials.gov平台对于其目标用户（研究参与者，尤其是孕妇）以及希望使用其数据进行研究的研究者而言存在的一些缺陷。其中一些缺陷包括信息缺失；缺乏对历史报告的强制要求；难以搜索针对孕妇而非胎儿的研究；无法始终找到针对特定孕期阶段的研究；以及缺乏有关研究干预措施是试验性的还是已获美国食品药品监督管理局（FDA）批准的信息。
