一项范围综述表明，有几种针对随机试验的未经验证的预算规划工具。

A scoping review shows that several nonvalidated budget planning tools for randomized trials are available.

机构信息

Nuffield Department of Orthopaedics, Centre for Statistics in Medicine, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland.

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland.

出版信息

J Clin Epidemiol. 2020 Jan;117:9-19. doi: 10.1016/j.jclinepi.2019.09.009. Epub 2019 Sep 15.

DOI:10.1016/j.jclinepi.2019.09.009

PMID:31533072

Abstract

OBJECTIVES

We aimed to provide a systematic overview of freely available tools which may help plan or monitor costs for randomized clinical trials (RCTs).

STUDY DESIGN AND SETTING

We systematically searched MEDLINE, EMBASE, and EconLit and conducted internet searches via Google (last search, October 2018). We included all freely available tools and determined their specific purpose, which parts of clinical trial projects and which types of costs they covered, and if they were user-tested or validated in any form.

RESULTS

We identified 25 available tools. Most tools were downloadable on websites from institutions related to clinical research. Seven tools were developed to plan the budget for an entire RCT, 17 tools for calculating budgets of an individual trial center, and one tool for monitoring costs of ongoing RCTs. Eighteen tools considered fixed, variable, and indirect costs. Only two tools were clearly user-tested or validated.

CONCLUSION

Several freely available tools aim to support investigators in planning costs of an entire trial or in planning the budget for a clinical trial site. How valid and useful they are remains to be shown for most of them. Future tools should be openly shared, user-tested, and validated.

摘要

目的

我们旨在提供一个系统的概述，其中可能有助于规划或监测随机临床试验（RCT）的成本的免费工具。

研究设计与设置

我们系统地搜索了 MEDLINE、EMBASE 和 EconLit，并通过谷歌进行了互联网搜索（最后一次搜索是在 2018 年 10 月）。我们包括了所有免费的工具，并确定了它们的具体用途，涵盖了临床试验项目的哪些部分以及哪些类型的成本，以及它们是否以任何形式进行了用户测试或验证。

结果

我们确定了 25 种可用的工具。大多数工具可从与临床研究相关的机构的网站上下载。有 7 种工具是为规划整个 RCT 的预算而开发的，17 种工具是为计算单个试验中心的预算而开发的，还有一种工具是用于监测正在进行的 RCT 的成本。有 18 种工具考虑了固定、可变和间接成本。只有两种工具经过了明确的用户测试或验证。