Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights

Author:

Marchenko Olga,Russek-Cohen Estelle,Levenson Mark,Zink Richard C.,Krukas-Hampel Michelle R.,Jiang Qi

Publisher

Springer Science and Business Media LLC

Subject

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

Reference88 articles.

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2. 21st Century Cures. https://energycommerce.house.gov/cures. Accessed April 23, 2017.

3. Pletcher MJ, Lo B, Grady D. Informed consent in randomized quality improvement trials: a critical barrier for learning health systems. JAMA Int Med. 2014;174:668–670.

4. Kass N, Faden R, Tunis S. Addressing low risk comparative effectiveness research in proposed changes to US federal regulations governing research. JAMA. 2012;307:1589–1590.

5. McKinney RE, Beskow LM, Ford DE, et al. Use of altered informed consent in pragmatic clinical research. Clin Trials. 2015;12:494–502.

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