Katz Nathaniel
Pain Rep. 2020 Dec 18;6(1):e845. doi: 10.1097/PR9.0000000000000854. eCollection 2021 Jan-Feb.
The purpose of this article is to provide readers with a basis for understanding the emerging science of clinical trials and to provide a set of practical, evidence-based suggestions for designing and executing confirmatory clinical trials in a manner that minimizes measurement error. The most important step in creating a mindset of quality clinical research is to abandon the antiquated concept that clinical trials are a method for capturing data from clinical practice and shifting to a concept of the clinical trial as a measurement system, consisting of an interconnected set of processes, each of which must be in calibration for the trial to generate an accurate and reliable estimate of the efficacy (and safety) of a given treatment. The status quo of inaccurate, unreliable, and protracted clinical trials is unacceptable and unsustainable. This article gathers aspects of study design and conduct under a single broad umbrella of techniques available to improve the accuracy and reliability of confirmatory clinical trials across traditional domain boundaries.
本文的目的是为读者提供理解新兴临床试验科学的基础，并提供一套实用的、基于证据的建议，以便以最小化测量误差的方式设计和开展确证性临床试验。营造高质量临床研究思维模式的最重要一步，是摒弃临床试验是从临床实践中获取数据的方法这一陈旧观念，转而将临床试验视为一个测量系统，该系统由一组相互关联的流程组成，每个流程都必须校准，以使试验能够准确可靠地估计给定治疗的疗效（和安全性）。不准确、不可靠且冗长的临床试验现状是不可接受且不可持续的。本文将研究设计和实施的各个方面整合在一个宽泛的技术框架下，这些技术可用于跨越传统领域界限提高确证性临床试验的准确性和可靠性。
