The Clinical Trials Transformation Initiative: innovation through collaboration-Reference-Cited by-同舟云学术

The Clinical Trials Transformation Initiative: innovation through collaboration

Published:2014-10-31 Issue:11 Volume:13 Page:797-798
ISSN:1474-1776
Container-title:Nature Reviews Drug Discovery
language:en
Short-container-title:Nat Rev Drug Discov

Author:

Tenaerts Pamela,Madre Leanne,Archdeacon Patrick,Califf Robert M.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Link

http://www.nature.com/articles/nrd4442.pdf

Reference5 articles.

1. Landray, M. J. et al. Clinical trials: rethinking how we ensure quality. Drug Inf. J. 46, 657–660 (2012).

2. Archdeacon, P. et al. Optimizing expedited safety reporting for drugs and biologics subject to an investigational new drug application. Ther. Innov. Regul. Sci. 48, 200–207 (2013).

3. US FDA. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Fed. Regist. 75, 59935–59963 (2010).

4. Menikoff, J. The paradoxical problem with multiple-IRB review. N. Engl. J. Med. 363, 1591–1593 (2010).

5. Flynn, K. E. et al. Using central IRBs for multicenter clinical trials in the United States. PLoS ONE 8, e54999 (2013).

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