Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials.
Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials.
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DOI：
10.2147/sar.s23796
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发表时间：
2011
影响因子：
1.8
通讯作者：
Perl HI
中科院分区：
文献类型：
--
作者：
Korte JE;Rosa CL;Wakim PG;Perl HI
从历史上看，种族和少数民族人口在临床研究中的代表性一直较低，在临床试验中招募和保留妇女和少数民族一直是研究人员面临的重大挑战。国家药物滥用治疗临床试验网络(CTN)在现实生活中进行临床试验，并定期监测一些对临床试验实施至关重要的变量，包括参与者的留存情况和人口统计数据。CTN试验中关于保留特征的性别、种族/民族和年龄组差异的检查。对招募了11,000多名参与者的24项已完成试验的报告进行了审查，并检查了性别、种族/民族和年龄组特征与治疗暴露比率、获得后续评估的比例以及主要结果衡量标准的可用性(S)。对CTN数据的分析没有表明不同性别或种族/族裔群体在保留率方面的统计差异；然而，老年参与者的保留率增加了。这些结果是基于从寻求治疗的人群中招募的药物使用障碍患者的大样本。研究结果表明，与老年人相比，年轻参与者在临床试验中被保留的可能性较小。
Historically, racial and ethnic minority populations have been underrepresented in clinical research, and the recruitment and retention of women and ethnic minorities in clinical trials has been a significant challenge for investigators. The National Drug Abuse Treatment Clinical Trials Network (CTN) conducts clinical trials in real-life settings and regularly monitors a number of variables critical to clinical trial implementation, including the retention and demographics of participants. The examination of gender, race/ethnicity, and age group differences with respect to retention characteristics in CTN trials. Reports for 24 completed trials that recruited over 11,000 participants were reviewed, and associations of gender, race/ethnicity, and age group characteristics were examined along with the rate of treatment exposure, the proportion of follow-up assessments obtained, and the availability of primary outcome measure(s). Analysis of the CTN data did not indicate statistical differences in retention across gender or race/ethnicity groups; however, retention rates increased for older participants. These results are based on a large sample of patients with substance use disorders recruited from a treatment-seeking population. The findings demonstrate that younger participants are less likely than older adults to be retained in clinical trials.