Conducting a pre-confirmatory clinical trial in case of insufficient participant accrual for an investigator-initiated confirmatory clinical trial
Author:
Affiliation:
1. Division of biostatistics Department of Social/Community Medicine and Health Science, Kobe University School of Medicine
2. Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University
Publisher
The Biometric Society of Japan
Subject
Industrial and Manufacturing Engineering,Polymers and Plastics,Business and International Management
Link
https://www.jstage.jst.go.jp/article/jjb/44/1/44_1/_pdf
Reference13 articles.
1. Dalt, D. L., Bressan, S., Scozzola, F., Vidal, E., Gennari, M., La Scola, C., et al. (2021). Oral steroids for reducing kidney scarring in young children with febrile urinary tract infections: the contribution of Bayesian analysis to a randomized trial not reaching its intended sample size. Pediatric Nephrology 36, 3681-3692.
2. Everitt, S. B. (2006). Medical statistics from A to Z: A Guide for Clinicians and Medical Students. 2nd edition. Cambridge University Press.
3. Hertzog, M. A. (2008). Considerations in determining sample size for pilot studies. Research in Nursing & Health, 31: 180-191.
4. International conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (1997). ICH harmonized tripartite guideline general considerations for clinical trials. https://database.ich.org/sites/default/files/E8_Guideline.pdf. (Accessed November 28, 2022).
5. Jairath, N., Hogerney, M., Parsons, C. (2000). The role of the pilot study: a case illustration from cardiac nursing research. Applied Nursing Research, 13: 92-96.
1.学者识别学者识别
2.学术分析学术分析
3.人才评估人才评估
"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370
www.globalauthorid.com
TOP
Copyright © 2019-2024 北京同舟云网络信息技术有限公司 京公网安备11010802033243号 京ICP备18003416号-3