Gnanasakthy A - Search Results

1

Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

Revicki DA, Gnanasakthy A, Weinfurt K. Revicki DA, et al. Among authors: gnanasakthy a. Qual Life Res. 2007 May;16(4):717-23. doi: 10.1007/s11136-006-9153-5. Epub 2007 Feb 1. Qual Life Res. 2007. PMID: 17268927

2

Patient reported outcomes: looking beyond the label claim.

Doward LC, Gnanasakthy A, Baker MG. Doward LC, et al. Among authors: gnanasakthy a. Health Qual Life Outcomes. 2010 Aug 20;8:89. doi: 10.1186/1477-7525-8-89. Health Qual Life Outcomes. 2010. PMID: 20727176 Free PMC article.

3

Patient-reported outcomes, patient-reported information: from randomized controlled trials to the social web and beyond.

Baldwin M, Spong A, Doward L, Gnanasakthy A. Baldwin M, et al. Among authors: gnanasakthy a. Patient. 2011;4(1):11-7. doi: 10.2165/11585530-000000000-00000. Patient. 2011. PMID: 21766890 Free PMC article.

4

Capturing patients' perspectives of treatment in clinical trials/drug development.

Hareendran A, Gnanasakthy A, Winnette R, Revicki D. Hareendran A, et al. Among authors: gnanasakthy a. Contemp Clin Trials. 2012 Jan;33(1):23-8. doi: 10.1016/j.cct.2011.09.015. Epub 2011 Oct 7. Contemp Clin Trials. 2012. PMID: 22001362 Review.

5

A review of patient-reported outcome labels in the United States: 2006 to 2010.

Gnanasakthy A, Mordin M, Clark M, DeMuro C, Fehnel S, Copley-Merriman C. Gnanasakthy A, et al. Value Health. 2012 May;15(3):437-42. doi: 10.1016/j.jval.2011.11.032. Epub 2012 Feb 2. Value Health. 2012. PMID: 22583453

6

Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006-2010.

DeMuro C, Clark M, Mordin M, Fehnel S, Copley-Merriman C, Gnanasakthy A. DeMuro C, et al. Among authors: gnanasakthy a. Value Health. 2012 May;15(3):443-8. doi: 10.1016/j.jval.2012.01.010. Value Health. 2012. PMID: 22583454

7

Integration of patient-reported outcomes in multiregional confirmatory clinical trials.

Gnanasakthy A, DeMuro C, Boulton C. Gnanasakthy A, et al. Contemp Clin Trials. 2013 May;35(1):62-9. doi: 10.1016/j.cct.2013.02.006. Epub 2013 Feb 13. Contemp Clin Trials. 2013. PMID: 23415630 Free PMC article. Clinical Trial.

8

Potential of patient-reported outcomes as nonprimary endpoints in clinical trials.

Gnanasakthy A, Lewis S, Clark M, Mordin M, DeMuro C. Gnanasakthy A, et al. Health Qual Life Outcomes. 2013 May 15;11:83. doi: 10.1186/1477-7525-11-83. Health Qual Life Outcomes. 2013. PMID: 23675876 Free PMC article.

9

US FDA patient-reported outcome guidance: great expectations and unintended consequences.

Fehnel S, DeMuro C, McLeod L, Coon C, Gnanasakthy A. Fehnel S, et al. Among authors: gnanasakthy a. Expert Rev Pharmacoecon Outcomes Res. 2013 Aug;13(4):441-6. doi: 10.1586/14737167.2013.814957. Expert Rev Pharmacoecon Outcomes Res. 2013. PMID: 23977972 Review.

10

Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).

DeMuro C, Clark M, Doward L, Evans E, Mordin M, Gnanasakthy A. DeMuro C, et al. Among authors: gnanasakthy a. Value Health. 2013 Dec;16(8):1150-5. doi: 10.1016/j.jval.2013.08.2293. Epub 2013 Oct 17. Value Health. 2013. PMID: 24326168

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