Department of Health Promotion of Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto.
Department of Management Science.
Alzheimer Dis Assoc Disord. 2020 Jan-Mar;34(1):97-100. doi: 10.1097/WAD.0000000000000297.
This study examined the primary and secondary endpoints used by recent phase II/III randomized controlled trials (RCTs) of drugs for the Alzheimer disease. We searched the Clinical Trials.gov database to identify all RCTs registered from January 1, 2011 until August 19, 2018. We identified 122 RCTs and examined primary and secondary endpoints most commonly used. The median number of primary endpoints was 1 (range: 1 to 48) and the median number of secondary endpoints was 4 (range: 1 to 19). Cognitive function was used as a primary endpoint by 59% of the RCTs identified. Although few trials included a primary outcome set that fulfilled the US Food and Drug Administration (FDA) or European Committee for Medicinal Products for Human Use (CHMP) requirements, these were met by a combination of the primary and secondary outcomes of more than half of the trials.
这项研究考察了最近的 II/III 期随机对照试验（RCT）中用于治疗阿尔茨海默病药物的主要和次要终点。我们搜索了 ClinicalTrials.gov 数据库，以确定所有在 2011 年 1 月 1 日至 2018 年 8 月 19 日期间注册的 RCT。我们确定了 122 项 RCT，并检查了最常用的主要和次要终点。主要终点的中位数数量为 1（范围：1 至 48），次要终点的中位数数量为 4（范围：1 至 19）。认知功能是 59%的 RCT 作为主要终点。虽然少数试验包括符合美国食品和药物管理局（FDA）或欧洲人用药品委员会（CHMP）要求的主要结果集，但这些都通过超过一半的试验的主要和次要结果的组合来满足。
