[生物统计学在机构审查委员会中的作用]

[The role of biostatistics in institutional review boards].

作者信息

Schlattmann Peter, Scherag André, Rauch Geraldine, Mansmann Ulrich

机构信息

Institut für medizinische Statistik, Informatik und Datenwissenschaften, FSU Jena, Universitätsklinikum Jena, Bachstr. 18, 07743, Jena, Deutschland.

Institut für Biometrie und Klinische Epidemiologie Berlin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Deutschland.

出版信息

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2019 Jun;62(6):751-757. doi: 10.1007/s00103-019-02951-9.

DOI:10.1007/s00103-019-02951-9

PMID:31065736

Abstract

Research in humans is associated with risks. These risks are only justifiable if an independent institutional review board (IRB) has evaluated the planned research in terms of scientific integrity. Only scientifically sound research can be considered ethical. A biostatistician should be a member of the IRB to assure adequate evaluation of fundamental topics like design, sample size estimation, and statistical analysis of the study.This paper presents core biostatistical concepts following the current guidelines of the International Council of Harmonization (ICH E6 and ICH E9). We discuss important pitfalls based on examples from published clinical trials. Furthermore, we discuss new concepts like estimands and their relevance for biostatisticians working in IRBs. Finally, we discuss the role of biostatisticians in IRBs and present thoughts on the way they should be trained.

摘要

人体研究存在风险。只有在独立的机构审查委员会（IRB）根据科学诚信对计划开展的研究进行评估之后，这些风险才具有合理性。只有科学合理的研究才被视为符合伦理道德。生物统计学家应成为IRB的成员，以确保对诸如研究设计、样本量估计和统计分析等基本问题进行充分评估。本文按照国际协调理事会（ICH E6和ICH E9）的现行指南介绍了核心生物统计学概念。我们基于已发表的临床试验实例讨论了重要的陷阱。此外，我们还讨论了诸如估计量等新概念及其对在IRB工作的生物统计学家的相关性。最后，我们讨论了生物统计学家在IRB中的作用，并就其应接受的培训方式提出了看法。