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本文引用的文献

1
How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.如何解读研究者手册以进行有意义的风险评估：AGA 讨论论坛的结果。
Ther Innov Regul Sci. 2021 May;55(3):612-618. doi: 10.1007/s43441-021-00257-0. Epub 2021 Feb 3.
2
Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies.I/II期试验的研究者手册缺乏关于临床前安全性研究稳健性的信息。
Br J Clin Pharmacol. 2021 Jul;87(7):2723-2731. doi: 10.1111/bcp.14615. Epub 2020 Nov 20.
3
Sex: A change in our guidelines to authors to ensure that this is no longer an ignored experimental variable.性别：我们已修改对作者的指导方针，以确保这不再是一个被忽视的实验变量。
Br J Pharmacol. 2019 Nov;176(21):4081-4086. doi: 10.1111/bph.14761. Epub 2019 Aug 23.
4
Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?研究者手册中的临床前疗效研究：它们是否能进行风险获益评估？
PLoS Biol. 2018 Apr 5;16(4):e2004879. doi: 10.1371/journal.pbio.2004879. eCollection 2018 Apr.
5
Experimental design and analysis and their reporting II: updated and simplified guidance for authors and peer reviewers.实验设计与分析及其报告（二）：给作者和同行评审者的更新且简化的指南
Br J Pharmacol. 2018 Apr;175(7):987-993. doi: 10.1111/bph.14153.
6
Estimation of clinical trial success rates and related parameters.临床试验成功率及相关参数的估计。
Biostatistics. 2019 Apr 1;20(2):273-286. doi: 10.1093/biostatistics/kxx069.
7
Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects.整合研究用药品档案/研究者手册中的数据。一种用于临床前效应转化整合的新工具。
Br J Clin Pharmacol. 2018 Jul;84(7):1457-1466. doi: 10.1111/bcp.13529. Epub 2018 May 15.
8
Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results.在临床开发后期失败的试验药物和试验结果的发表。
JAMA Intern Med. 2016 Dec 1;176(12):1826-1833. doi: 10.1001/jamainternmed.2016.6008.
9
The history and fate of the gold standard.金本位制的历史与命运。
Lancet. 2015 Apr 18;385(9977):1502-3. doi: 10.1016/S0140-6736(15)60742-5.
10
Reproducibility of research and preclinical validation: problems and solutions.研究和临床前验证的可重复性：问题与解决方案。
Nat Rev Clin Oncol. 2013 Dec;10(12):720-4. doi: 10.1038/nrclinonc.2013.171. Epub 2013 Oct 1.

Commentary on "Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies" by Sievers et al.

作者信息

Rissmann Robert, Zuiker Rob

机构信息

Centre for Human Drug Research, Leiden, The Netherlands.

Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.

出版信息

Br J Clin Pharmacol. 2021 Jul;87(7):2633-2634. doi: 10.1111/bcp.14823. Epub 2021 Mar 24.

DOI:10.1111/bcp.14823
PMID:33763864
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8359845/
Abstract
摘要