Measuring the Incidence, Causes, and Repercussions of Protocol Amendments-Reference-Cited by-同舟云学术

Measuring the Incidence, Causes, and Repercussions of Protocol Amendments

Published:2011-05 Issue:3 Volume:45 Page:265-275
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Getz Kenneth A.,Zuckerman Rachael,Cropp Anne B.,Hindle Anna L.,Krauss Randy,Kaitin Kenneth I.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)

Link

http://link.springer.com/content/pdf/10.1177/009286151104500307.pdf

Reference6 articles.

1. Getz K. The heavy burden of protocol design. Appl Clin Trials. 2008; 17(5):38–40.

2. Getz K, Wenger J, Campo R, Seguine E, Kaitin K. Assessing the impact of protocol design change on clinical trial performance. Am J Ther. 2008; 15:449–456.

3. Wise P. Drury M. Pharmaceutical trials in general practice: the first 100 protocols. Br Med J. 1996; 313:1245–1248.

4. Losch C. Neuhauser M. The statistical analysis of a clinical trial when a protocol amendment changed the inclusion criteria. BMC Med Res Meth. 2008;8(16): 1–9.

5. Getz K. The downstream impact of protocol design complexity. Drug Devel Touch Brief. 2009; 93–95.

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