Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials-Reference-Cited by-同舟云学术

Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials

Published:2013-07 Issue:4 Volume:47 Page:495-502
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Antonijevic Zoran,Gallo Paul,Chuang-Stein Christy,Dragalin Vladimir,Loewy John,Menon Sandeep,Miller Eva R.,Morgan Caroline Claire,Sanchez Matilde

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/10.1177/2168479013486996.pdf

Reference13 articles.

1. European Medicines Agency. Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. 2007. http://www.emea.europa.eu/pdfs/human/ewp/245902enadopted.pdf. Accessed October 18, 2007.

2. US Food and Drug Administration. Draft guidance for industry: adaptive design clinical trials for drugs and biologics. February 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf.

3. Ellenberg S, Fleming T, DeMets D. Data Monitoring Committees in Clinical Trials: A Practical Perspective. New York, NY: Wiley; 2002.

4. US Food and Drug Administration. Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monitoring committees. March 2006. http://www.fda.gov/downloads/Regulatoryinformation/Guidances/ucm127073.pdf.

5. European Medicines Agency. Guideline on data monitoring committees. 2006. July 27, 2005. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003635.pdf.

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