Utilizing shared internal control arms and historical information in small-sized platform clinical trials-Reference-Cited by-同舟云学术

Utilizing shared internal control arms and historical information in small-sized platform clinical trials

Published:2019-08-28 Issue:5 Volume:29 Page:845-859
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Jiao Feiran¹,Tu Wenda²,Jimenez Sara³,Crentsil Victor³,Chen Yeh-Fong³

Affiliation:

1. Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA

2. Department of Statistics & Actuarial Science, University of Iowa, Iowa City, IA, USA

3. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2019.1657132

Reference21 articles.

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4. Food and Drug Administration 1998. Guidance for industry: Providing clinical evidence and effectiveness for human drug and biologic products.

5. Food and Drug Administration 2017. Guidance for industry: Pediatric rare diseases – a collaborative approach for drug development using gaucher disease as a model guidance for industry.

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