首页> 外文期刊>Science as Culture >Alter-Standardizing Clinical Trials: The Gold Standard in the Crossfire
【24h】

Alter-Standardizing Clinical Trials: The Gold Standard in the Crossfire

机译:改变标准化临床试验:交火中的黄金标准

获取原文
获取原文并翻译 | 示例
       

摘要

The international landscape of medical research is in the midst of a process of diversification and change. The randomized controlled trial (RCT), long considered the global gold standard for clinical research, has become increasingly contested and is partly replaced by alternative methodologies, standards and forms of evidence. The contours of mainstream medical research are changing as a result. Regulatory paradigms and standards are, literally, being rewritten, at a global level. The evidence-based medicine (EBM) hierarchy of evidence is redefined. This special issue explores these developments through the concept of 'alter-standardization'. The term refers to the processes, controversies and negotiations through which multiphase RCTs and the EBM system are challenged and gradually superseded by alternative methodological and regulatory forms and standards. This special issue examines the conceptual, practical and theoretical implications of these changes, and the ways in which these transformations influence the situation and possibilities of patients, knowledge producers, physicians, large pharmaceutical corporations, smaller biotech companies, as well as regulatory bodies, civil societal organizations and national health care systems. The articles in this special issue make use of comparative and historical perspectives that focus on scientific, social, economic and regulatory developments in the European Union, China, India, Japan, Argentina, the UK and the USA. They show that the alter-standardizing of clinical trials arises in a pluralistic way, that is driven by a variety of often conflicting factors, developments and expectations. These changes reflect a broad transformation in the culture and politics of biomedicine today, with implications for the ways in which new medicinal products, devices, procedures and technologies are developed, approved for clinical use, sold to consumers, and licensed by health care systems.
机译:医学研究的国际景观是在多元化和变革过程中。随机对照试验(RCT),长期以来,临床研究的全球黄金标准越来越受到竞争,部分地由替代方法,标准和证据形式取代。主流医学研究的轮廓是由于导致的变化。实际上是监管范式和标准,在全球层面被重写。证据的证据(EBM)的证据层次被重新定义。此特殊问题通过“Alter-Standardization”的概念探讨了这些发展。该术语是指多相RCT和EBM系统的过程,争议和谈判受到挑战,逐渐通过替代方法和监管形式和标准逐渐取代。这一特殊问题研究了这些变化的概念,实际和理论意义,以及这些转型影响患者,知识生产商,医生,大型制药公司,较小的生物技术公司以及监管机构,民事的方式的方式社会组织和国家医疗保健系统。本特刊中的文章利用了比较和历史观点,重点关注欧盟,中国,印度,日本,阿根廷,英国和美国的科学,社会,经济和监管发展。他们表明,临床试验的改变标准化以多元化的方式出现,这是由各种经常相互矛盾的因素,发展和期望驱动的。这些变化反映了今天生物医学的文化和政治的广泛转型,并对开发了新的药用产品,设备,程序和技术的方式,批准用于临床使用,销售给消费者,并由医疗保健系统授权。

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