Melding Regulatory, Pharmaceutical Industry, and U.S. Payer Perspectives on Improving Approaches to Heterogeneity of Treatment Effect in Research and Practice

Author:

Willke Richard J.,Crown William,del Aguila Michael,Cziraky Mark J.,Khan Zeba M.,Migliori Richard

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference34 articles.

1. Priorities for Personalized Medicine,2008

2. Evidence-based medicine, heterogeneity of treatment effects, and the trouble with averages;Kravitz;Milbank Q,2004

3. Redekop K, Mladsi D. The faces of personalized medicine: a framework for understanding its meaning and scope. Value Health 2013;16(Suppl.):S4–9

4. ISPOR Institutional Council Comparative Effectiveness Research Working Group. “Differences on differences: does perspective matter when considering heterogeneity of treatment effect?” ISPOR Forum at the ISPOR 15th Annual International Meetings, May 2011; Baltimore, MD.

5. US Food and Drug Administration. Guidance for Industry: E9 Statistical Principles for Clinical Trials. Washington, DC: U.S. Department of Health and Human Services, September 1998.

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