Biomarkers and surrogate endpoints in clinical trials

Author:

Fleming Thomas R.1,Powers John H.

Affiliation:

1. Department of Biostatistics; University of Washington; Seattle; WA; USA

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference35 articles.

1. US Government Printing Office Applications for FDA approval to market a new drug: adequate and well-controlled studies http://edocket.access.gpo.gov/cfr_2009/aprqtr/21cfr314.126.htm

2. Patrick DL Burke LB Gwaltney CJ Leidy NK Martin ML Molsen E Ring L Content validity-establishing and reporting the evidence in newly developed Patient-Reported Outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1-eliciting concepts for a new PRO instrument http://www.valueinhealthjournal.com/article/S1098-3015(11)03323-7/abstract

3. Patrick DL Burke LB Gwaltney CJ Leidy NK Martin ML Molsen E Ring L Content validity-establishing and reporting the evidence in newly developed Patient-Reported Outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 2-assessing respondent understanding http://www.valueinhealthjournal.com/article/S1098-3015(11)03321-3/abstract

4. Guidance for industry patient-reported outcome measures: Use in medical product development to support labeling claims 2009 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf

5. et al. Secondary prevention of macrovascular events in patients with type 2 diabetes: a randomized trial of pioglitazone. The PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events);Dormandy;Lancet,2005

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