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.
Abstract
摘要
相似文献
1
Commentary on "Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies" by Sievers et al.
Br J Clin Pharmacol. 2021 Jul;87(7):2633-2634. doi: 10.1111/bcp.14823. Epub 2021 Mar 24.
2
Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies.
Br J Clin Pharmacol. 2021 Jul;87(7):2723-2731. doi: 10.1111/bcp.14615. Epub 2020 Nov 20.
3
Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?
PLoS Biol. 2018 Apr 5;16(4):e2004879. doi: 10.1371/journal.pbio.2004879. eCollection 2018 Apr.
4
A cross-sectional evidence-based review of pharmaceutical promotional marketing brochures and their underlying studies: is what they tell us important and true?
BMC Fam Pract. 2006 Mar 3;7:13. doi: 10.1186/1471-2296-7-13.
5
The readability and audience acceptance of printed health promotion materials used by environmental health departments.
J Environ Health. 2003 Jan-Feb;65(6):22-8.
6
Are women getting relevant information about mammography screening for an informed consent: a critical appraisal of information brochures used for screening invitation in Germany, Italy, Spain and France.
Eur J Public Health. 2010 Aug;20(4):409-14. doi: 10.1093/eurpub/ckp174. Epub 2009 Nov 5.
7
Health and safety information carried by travel brochures in Australia.
Med J Aust. 2001 Feb 5;174(3):150. doi: 10.5694/j.1326-5377.2001.tb143194.x.
8
Descriptive information about Crohn disease: content analysis of patient education brochures.
Gastroenterol Nurs. 2010 Nov-Dec;33(6):432-9. doi: 10.1097/SGA.0b013e3182033d49.
9
Analysis of German nutrition brochures for pregnant women with evidence-based patient information criteria.
Patient Educ Couns. 2015 Feb;98(2):207-12. doi: 10.1016/j.pec.2014.10.015. Epub 2014 Oct 28.
10
[Analysis of German language consumer information brochures on screening for colorectal cancer].
Z Arztl Fortbild Qualitatssich. 2001 Aug;95(8):535-8.
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.
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.
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.
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?
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.
Br J Pharmacol. 2018 Apr;175(7):987-993. doi: 10.1111/bph.14153.
6
Estimation of clinical trial success rates and related parameters.
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.
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.
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.
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.
Nat Rev Clin Oncol. 2013 Dec;10(12):720-4. doi: 10.1038/nrclinonc.2013.171. Epub 2013 Oct 1.
Zotero 插件