...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>American journal of therapeutics >Demographics of Clinical Trials Participants in Pivotal Clinical Trials for New Molecular Entity Drugs and Biologics Approved by FDA From 2010 to 2012
【24h】

Demographics of Clinical Trials Participants in Pivotal Clinical Trials for New Molecular Entity Drugs and Biologics Approved by FDA From 2010 to 2012

机译：2010年至2012年间FDA批准的新分子实体药物和生物制剂关键临床试验参与者的临床试验人口统计

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

To fully assess the safety and efficacy of therapeutics before approval, the US Food and Drug Administration (FDA) has encouraged adequate representation and assessment of demographic subgroups in clinical trials through guidance documents and regulations. This study aimed to survey the demographics of participants in pivotal clinical trials, as well as the presence of analyses by sex on efficacy and safety for FDA-approved new drug applications (NDAs) and biologics license applications (BLAs) from 2010 to 2012. Medical and statistical reviews for new molecular entity drugs and biological products approved during this period were obtained from Drugs@FDA. All pivotal clinical trials referenced in the FDA reviews were evaluated for the participation of different demographic subgroups (such as sex, race/ethnicity, and age). Pivotal trials were defined as those phase 2 and/or phase 3 trials described in the labeling or the FDA medical reviews in support of the drug/biological approval. Eighty-three new molecular entities (66 NDAs and 17 BLAs) were approved by the FDA from 2010 to 2012. Overall, women constituted 45% of trial participants for NDAs and 65% for BLAs. Sex analysis related to safety and efficacy was reported in 92% of the surveyed FDA medical and statistical reviews. Most NDAs and BLAs (82%) had a study population that was representative of the sex distribution for the intended patient population; however, most study participants were whites (77%), and minority racial/ethnic groups had lower participation rates in the study population than would be representative of the US racial group populations.
机译：为了在批准前全面评估治疗剂的安全性和有效性，美国食品药品监督管理局（FDA）鼓励通过指导文件和法规在临床试验中对人口统计学亚组进行充分的代表和评估。这项研究旨在调查关键临床试验参与者的人口统计数据，以及从2010年至2012年按性别对FDA批准的新药申请（NDA）和生物制剂许可申请（BLA）的功效和安全性进行分析的情况。有关此期间批准的新分子实体药物和生物产品的统计评论可从Drugs @ FDA获得。评估了FDA审查中引用的所有关键性临床试验，以评估不同人口统计学亚组（例如性别，种族/民族和年龄）的参与情况。关键性试验定义为标签或FDA药品审查中描述的支持药物/生物学批准的第2期和/或第3期试验。从2010年到2012年，FDA批准了83个新的分子实体（66个NDA和17个BLA）。总体而言，妇女占NDA的试验参与者的45％，占BLA的65％。在被调查的FDA医疗和统计评论中，有92％报告了与安全性和有效性相关的性别分析。大多数NDA和BLA（82％）的研究人群代表了预期患者人群的性别分布。但是，大多数研究参与者是白人（77％），少数种族/族裔群体对研究人群的参与率低于美国种族群体。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号