美国炎症性肠病三期临床试验可及性方面的地域不平等现象。
Geographic Inequities in Access to Phase 3 Clinical Trials for Inflammatory Bowel Disease in the United States.
作者信息
Boyd Taylor, Ananthakrishnan Ashwin N
机构信息
Harvard Medical School, Boston, Massachusetts; Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.
Harvard Medical School, Boston, Massachusetts; Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.
出版信息
Clin Gastroenterol Hepatol. 2024 Mar;22(3):659-661.e3. doi: 10.1016/j.cgh.2023.07.026. Epub 2023 Aug 11.
Randomized controlled trials (RCTs) are an important mode of access to treatments for patients with inflammatory bowel diseases (IBDs) (eg, Crohn's disease [CD], ulcerative colitis [UC]), and a critical step in the regulatory process toward the approval of new therapies. Prior studies examining disparities in RCT participation for patients with IBD have importantly focused on racial and age-related disparities. Lack of geographic access to trials may be an important barrier to participation and a source of inequity. The aim of our study was to geographically map access to phase 3 clinical trials in IBD within the United States, and identify the impact of rural residence and socioeconomic status on access to trials.
随机对照试验（RCTs）是炎症性肠病（IBDs）（如克罗恩病[CD]、溃疡性结肠炎[UC]）患者获得治疗的重要途径，也是新疗法获批监管过程中的关键一步。先前关于IBD患者参与RCT差异的研究主要集中在种族和年龄相关的差异上。缺乏参与试验的地理途径可能是参与的一个重要障碍和不平等的一个来源。我们研究的目的是在美国对IBD的3期临床试验的参与途径进行地理定位，并确定农村居住和社会经济地位对试验参与途径的影响。
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