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本文引用的文献

1
What makes a biostatistician?成为一名生物统计学家需要具备什么条件?
Stat Med. 2019 Feb 20;38(4):695-701. doi: 10.1002/sim.7998. Epub 2018 Oct 7.
2
A proposal for a new PhD level curriculum on quantitative methods for drug development.一份关于药物研发定量方法的新博士水平课程提案。
Pharm Stat. 2018 Sep;17(5):593-606. doi: 10.1002/pst.1873. Epub 2018 Jul 9.
3
Extrapolation of efficacy and other data to support the development of new medicines for children: A systematic review of methods.外推疗效及其他数据以支持儿童新药研发:方法的系统评价
Stat Methods Med Res. 2018 Feb;27(2):398-413. doi: 10.1177/0962280216631359. Epub 2016 Mar 17.
4
Systematic Reviews and Meta-analysis: Understanding the Best Evidence in Primary Healthcare.系统评价与Meta分析:理解初级卫生保健中的最佳证据。
J Family Med Prim Care. 2013 Jan;2(1):9-14. doi: 10.4103/2249-4863.109934.
5
QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies.QUADAS-2:用于诊断准确性研究质量评估的修订工具。
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Rationale for systematic reviews.系统评价的基本原理。
BMJ. 1994 Sep 3;309(6954):597-9. doi: 10.1136/bmj.309.6954.597.
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International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).人用药品注册技术要求国际协调会议(ICH)
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Multistate modelling of liver transplantation data.肝移植数据的多状态建模
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为什么需要生物统计学家?

Why do you need a biostatistician?

机构信息

Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, 10117, Berlin, Germany.

出版信息

BMC Med Res Methodol. 2020 Feb 5;20(1):23. doi: 10.1186/s12874-020-0916-4.

DOI:10.1186/s12874-020-0916-4
PMID:32024478
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7003429/
Abstract

The quality of medical research importantly depends, among other aspects, on a valid statistical planning of the study, analysis of the data, and reporting of the results, which is usually guaranteed by a biostatistician. However, there are several related professions next to the biostatistician, for example epidemiologists, medical informaticians and bioinformaticians. For medical experts, it is often not clear what the differences between these professions are and how the specific role of a biostatistician can be described. For physicians involved in medical research, this is problematic because false expectations often lead to frustration on both sides. Therefore, the aim of this article is to outline the tasks and responsibilities of biostatisticians in clinical trials as well as in other fields of application in medical research.

摘要

医学研究的质量在很大程度上取决于研究的统计规划、数据分析和结果报告的有效性,这些通常由生物统计学家来保证。然而,除了生物统计学家,还有其他几个相关的专业,例如流行病学家、医学信息学家和生物信息学家。对于医学专家来说,这些专业之间的区别以及生物统计学家的具体角色通常并不清楚。对于参与医学研究的医生来说,这是有问题的,因为错误的期望往往会导致双方的沮丧。因此,本文的目的是概述临床试验以及医学研究其他应用领域中生物统计学家的任务和职责。