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临床试验实施:神经外科医生入门。

Clinical trial implementation: a primer for neurosurgeons.

机构信息

1Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.

2Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida.

出版信息

J Neurosurg. 2023 Apr 14;139(5):1439-1445. doi: 10.3171/2023.2.JNS221937. Print 2023 Nov 1.

Abstract

In the current landscape of evidence-based medicine, prospective clinical trials are an important avenue through which to establish the efficacy and safety of biomedical treatments compared with standard-of-care interventions. Depending on their scope and aims, clinical trials can be extremely costly and time intensive, and significant coordination is needed to ensure optimal utilization of healthcare resources, adherence to the principles of biomedical ethics, and appropriate interpretation of study results. This review highlights the core principles for designing and implementing clinical trials within neurosurgery, with the aim to provide clinicians with a framework for implementing both investigator-initiated and industry-sponsored trials.

摘要

在当前循证医学的背景下,前瞻性临床试验是一种重要的途径,可以用来确定与标准治疗干预相比,生物医学治疗的疗效和安全性。根据其范围和目的,临床试验可能非常昂贵且耗时,需要进行大量协调,以确保医疗资源的最佳利用、生物医学伦理原则的遵守以及研究结果的适当解释。这篇综述强调了神经外科临床试验设计和实施的核心原则,旨在为临床医生提供一个框架,以实施研究者发起的和行业赞助的试验。

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