Omitting placebos from early-stage clinical trials of cystic fibrosis therapies

Author:

Simon Richard H.ORCID,Quittell Lynne M.ORCID,Morgan Wayne J.ORCID

Funder

Cystic Fibrosis Foundation

Publisher

Elsevier BV

Subject

Pulmonary and Respiratory Medicine,Pediatrics, Perinatology and Child Health

Reference17 articles.

1. Inclusion of placebos and blinding for ascending dose first-in-human studies and other underpowered phase 1 studies has not been justified and on balance is not useful;Parasrampuria;Basic Clin Pharmacol Toxicol,2015

2. Building global development strategies for CF therapeutics during a transitional CFTR modulator era;Mayer-Hamblett;J Cyst Fibros,2020

3. U.S. Department of Health and Human Services Food and Drug Administration, Guidance for Industry. E 10 Choice of Control Group and Related Issues in Clinical Trials. 2001. https://www.fda.gov/media/71349/download. Accessed on October 18, 2023.

4. U.S. Department of Health and Human Services Food and Drug Administration, Rare Diseases: Common Issues in Drug Development. Guidance for Industry. 2019. https://www.fda.gov/media/119757/download. Accessed on October 18, 2023.

5. U.S. Department of Health and Human Services Food and Drug Administration, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. 2019. https://www.fda.gov/media/133660/download. Accessed on October 18, 2023.

同舟云学术

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