Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework-Reference-Cited by-同舟云学术

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Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework

Published:2016-06-03 Issue:7 Volume:15 Page:516-516
ISSN:1474-1776
Container-title:Nature Reviews Drug Discovery
language:en
Short-container-title:Nat Rev Drug Discov

Author:

Ciani Oriana,Buyse Marc,Drummond Mike,Rasi Guido,Saad Everardo D.,Taylor Rod S.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Link

http://www.nature.com/articles/nrd.2016.81.pdf

Reference10 articles.

1. Downing, N. S., Krumholz, H. M., Ross, J. S. & Shah, N. D. Characterizing the US FDA's approach to promoting transformative innovation. Nat. Rev. Drug Discov. 14, 740–741 (2015).

2. Downing, N. S., Aminawung, J. A., Shah, N. D., Krumholz, H. M. & Ross, J. S. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012. JAMA 311, 368–377 (2014).

3. Clement, F. M. et al. Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA 302, 1437–1443 (2009).

4. Fleming, T. R. & DeMets, D. L. Surrogate end points in clinical trials: are we being misled? Ann. Intern. Med. 125, 605–613 (1996).

5. Ciani, O. et al. Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study. BMJ 346, f457 (2013).

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