Clinical Study Design to Assess Both Short- and Long-term Efficacy in Addition to Group Sequential Test on Safety
Author:
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/10.1177/2168479018759660.pdf
Reference15 articles.
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3. Xi D, Tamhane AC. Allocating recycled significance levels in group sequential procedures for multiple endpoints. Biomet J. 2015;57:90–107.
4. FDA. Guidance for industry: Providing Clinical Evidence and Effectiveness for Human Drug and Biologic Products. 1998.
5. DeMets DL, Lan G. The alpha spending function approach to interim data analyses. In: Thrall PF, ed. Recent Advances in Clinical Trial Design and Analysis. Boston, MA: Kluwer Academic; 1995:1–27.
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