205 related articles for article (PubMed ID: 21123768)
1. Use of patient-reported outcomes in medical product development: a report from the 2009 NEI/FDA Clinical Trial Endpoints Symposium.
Varma R; Richman EA; Ferris FL; Bressler NM
Invest Ophthalmol Vis Sci; 2010 Dec; 51(12):6095-103. PubMed ID: 21123768
[No Abstract] [Full Text] [Related]
2. Report from the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium.
Csaky KG; Richman EA; Ferris FL
Invest Ophthalmol Vis Sci; 2008 Feb; 49(2):479-89. PubMed ID: 18234989
[No Abstract] [Full Text] [Related]
3. Glaucoma research community and FDA look to the future, II: NEI/FDA Glaucoma Clinical Trial Design and Endpoints Symposium: measures of structural change and visual function.
Weinreb RN; Kaufman PL
Invest Ophthalmol Vis Sci; 2011 Oct; 52(11):7842-51. PubMed ID: 21972262
[No Abstract] [Full Text] [Related]
4. The glaucoma research community and FDA look to the future: a report from the NEI/FDA CDER Glaucoma Clinical Trial Design and Endpoints Symposium.
Weinreb RN; Kaufman PL
Invest Ophthalmol Vis Sci; 2009 Apr; 50(4):1497-505. PubMed ID: 19321793
[No Abstract] [Full Text] [Related]
5. Report From the NEI/FDA Diabetic Retinopathy Clinical Trial Design and Endpoints Workshop.
Nair P; Aiello LP; Gardner TW; Jampol LM; Ferris FL
Invest Ophthalmol Vis Sci; 2016 Oct; 57(13):5127-5142. PubMed ID: 27699406
[No Abstract] [Full Text] [Related]
6. Report From the National Eye Institute Workshop on Neuro-Ophthalmic Disease Clinical Trial Endpoints: Optic Neuropathies.
Levin LA; Sengupta M; Balcer LJ; Kupersmith MJ; Miller NR
Invest Ophthalmol Vis Sci; 2021 Nov; 62(14):30. PubMed ID: 34846515
[No Abstract] [Full Text] [Related]
7. Ophthalmic Drug Discovery and Development: Regulatory Aspects of Patient Focused Drug Development in Ophthalmology.
Rowe-Rendleman CL
Pharm Res; 2019 Feb; 36(4):54. PubMed ID: 30790065
[TBL] [Abstract][Full Text] [Related]
8. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels.
Willke RJ; Burke LB; Erickson P
Control Clin Trials; 2004 Dec; 25(6):535-52. PubMed ID: 15588741
[TBL] [Abstract][Full Text] [Related]
9. Potential of patient-reported outcomes as nonprimary endpoints in clinical trials.
Gnanasakthy A; Lewis S; Clark M; Mordin M; DeMuro C
Health Qual Life Outcomes; 2013 May; 11():83. PubMed ID: 23675876
[TBL] [Abstract][Full Text] [Related]
10. FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper.
Herzog TJ; Ison G; Alvarez RD; Balasubramaniam S; Armstrong DK; Beaver JA; Ellis A; Tang S; Ford P; McKee A; Gershenson DM; Kim G; Monk BJ; Pazdur R; Coleman RL
Gynecol Oncol; 2017 Oct; 147(1):3-10. PubMed ID: 28844539
[No Abstract] [Full Text] [Related]
11. Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium.
Fangusaro J; Avery RA; Fisher MJ; Packer RJ; Walsh KS; Schouten-van Meeteren A; Karres D; Bradford D; Bhatnagar V; Singh H; Kluetz PG; Donoghue M; Duke ES
Clin Cancer Res; 2024 Jun; 30(11):2303-2308. PubMed ID: 38358393
[TBL] [Abstract][Full Text] [Related]
12. Adaptive trials.
Novack GD
Ocul Surf; 2006 Oct; 4(4):215-6. PubMed ID: 17146577
[No Abstract] [Full Text] [Related]
13. Responsiveness and minimal important differences for patient reported outcomes.
Revicki DA; Cella D; Hays RD; Sloan JA; Lenderking WR; Aaronson NK
Health Qual Life Outcomes; 2006 Sep; 4():70. PubMed ID: 17005038
[TBL] [Abstract][Full Text] [Related]
14. Patient-reported outcomes in clinical trials of CKD-related therapies: report of a symposium sponsored by the national kidney foundation and the U.S. Food and Drug Administration.
Perrone RD; Coons SJ; Cavanaugh K; Finkelstein F; Meyer KB
Am J Kidney Dis; 2013 Dec; 62(6):1046-57. PubMed ID: 23988757
[TBL] [Abstract][Full Text] [Related]
15. Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community.
Driver VR; Gould LJ; Dotson P; Gibbons GW; Li WW; Ennis WJ; Kirsner RS; Eaglstein WH; Bolton LL; Carter MJ
Wound Repair Regen; 2017 May; 25(3):454-465. PubMed ID: 28370922
[TBL] [Abstract][Full Text] [Related]
16. Beyond the FDA PRO guidance: steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels.
Basch E
Value Health; 2012 May; 15(3):401-3. PubMed ID: 22583448
[No Abstract] [Full Text] [Related]
17. Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop.
Bast RC; Thigpen JT; Arbuck SG; Basen-Engquist K; Burke LB; Freedman R; Horning SJ; Ozols R; Rustin GJ; Spriggs D; Wenzel LB; Pazdur R
Gynecol Oncol; 2007 Nov; 107(2):173-6. PubMed ID: 17950384
[TBL] [Abstract][Full Text] [Related]
18. Discrepancies Between FDA-Required Labeling and Evidence that Payers Cite in Drug Coverage Policies.
Chambers JD; Pope EF; Wilkinson CL; Neumann PJ
J Manag Care Spec Pharm; 2018 Dec; 24(12):1240-1246. PubMed ID: 30479201
[TBL] [Abstract][Full Text] [Related]
19. Some remaining challenges regarding multiple endpoints in clinical trials.
Snapinn S
Stat Med; 2017 Dec; 36(28):4441-4445. PubMed ID: 28664566
[TBL] [Abstract][Full Text] [Related]
20. Evaluation of minimum clinically meaningful changes in scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ) SST Report Number 19.
Submacular Surgery Trials Research Group
Ophthalmic Epidemiol; 2007; 14(4):205-15. PubMed ID: 17896299
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
