Piper R D, Cook D J, Bone R C, Sibbald W J
Department of Medicine, University of Western Ontario, London, Canada.
Crit Care Med. 1996 Dec;24(12):2059-70. doi: 10.1097/00003246-199612000-00021.
To discuss theoretical and practical aspects relating to the design of animal studies investigating the efficacy of novel therapeutic agents for the treatment of sepsis, and to make explicit the process whereby these studies can be evaluated for the purpose of designing clinical trials in humans.
Relevant articles from the pertinent literature were reviewed.
Studies relevant to an evidence-based assessment of clinical studies on therapeutic efficacy, and studies relevant to the design of animal models of sepsis were selected.
Concepts relevant to an evidence-based assessment of the animal literature were extracted.
Articles were reviewed and an evidence-based framework for the assessment of animal studies was developed. In this process, we discuss the steps that are necessary to assess the internal validity of an individual study and review topics relevant to the application of animal data to the design of clinical trials.
The success of clinical trials of sepsis therapies is predicated on the generation and interpretation of sound preclinical data. In this review, we have attempted to outline an evidence-based approach to the assessment of preclinical animal studies evaluating novel therapeutic interventions in sepsis.
探讨与设计动物研究相关的理论和实践问题，这些研究旨在调查新型治疗药物治疗脓毒症的疗效，并明确为设计人体临床试验而对这些研究进行评估的过程。
查阅了相关文献中的相关文章。
选择与基于证据评估治疗疗效的临床研究相关的研究，以及与脓毒症动物模型设计相关的研究。
提取与基于证据评估动物文献相关的概念。
对文章进行了综述，并建立了一个基于证据的动物研究评估框架。在此过程中，我们讨论了评估单个研究内部有效性所需的步骤，并回顾了与将动物数据应用于临床试验设计相关的主题。
脓毒症治疗临床试验的成功取决于可靠的临床前数据的产生和解释。在本综述中，我们试图概述一种基于证据的方法，用于评估评估脓毒症新型治疗干预措施的临床前动物研究。
