CBER’s Experience With Adaptive Design Clinical Trials-Reference-Cited by-同舟云学术

CBER’s Experience With Adaptive Design Clinical Trials

Published:2016-03 Issue:2 Volume:50 Page:195-203
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Lin Min,Lee Shiowjen,Zhen Boguang,Scott John,Horne Amelia,Solomon Ghideon,Russek-Cohen Estelle

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479015604181.pdf

Reference36 articles.

1. Chow SC, Chang M. Adaptive Design Methods in Clinical Trials. 2nd ed. New York, NY: Chapman and Hall/CRC, Taylor and Francis; 2011.

2. Chow SC, Chang M. Adaptive design methods in clinical trials—a review. Orphanet J Rare Dis. 2008;3:11.

3. Coffey CS, Kairalla JA. Adaptive clinical trials—progress and challenges. Drugs R&D. 2008;9:229–242.

4. Kairalla JA, Coffey CS, Thomann MA, Muller KE. Adaptive trial designs: a review of barriers and opportunities. Trials. 2012;13:145.

5. FDA. Draft guidance for industry—adaptive design clinical trials for drugs and biologics. http://www.fda.gov/downloads/Drugs/…/Guidances/ucm201790.pdf. Published 2010.

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