Department of Internal Medicine, University of Utah, Salt Lake City, UT, Seattle, WA.
Medical Scientist Training Program, University of Washington, Seattle, WA.
Am Heart J. 2021 Apr;234:133-135. doi: 10.1016/j.ahj.2020.12.006. Epub 2021 Jan 23.
Clinical trials provide the foundational evidence that guide many patient-facing decisions; however, the therapeutic effect and safety of an intervention is best evaluated when compared to a control group. We used ClinicalTrials.gov to describe the proportion of registered Phase III and IV cardiovascular clinical trials that contain a control group from 2009 through 2019. Of 1,677 registered Phase III and IV cardiovascular clinical trials, 81.2% contain a control group, and the annual prevalence remained unchanged between 2009 and 2019.
临床试验提供了指导许多面向患者的决策的基础证据；然而，干预措施的治疗效果和安全性只有在与对照组进行比较时才能得到最佳评估。我们使用 ClinicalTrials.gov 描述了 2009 年至 2019 年期间注册的 III 期和 IV 期心血管临床试验中包含对照组的比例。在注册的 1677 项 III 期和 IV 期心血管临床试验中，81.2%包含对照组，且 2009 年至 2019 年期间，其年度发生率保持不变。
