These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

259 related articles for article (PubMed ID: 22583453)

  • 1. 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
    Value Health; 2012 May; 15(3):437-42. PubMed ID: 22583453
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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
    Value Health; 2012 May; 15(3):443-8. PubMed ID: 22583454
    [TBL] [Abstract][Full Text] [Related]  

  • 3. 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]  

  • 4. 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
    Value Health; 2013 Dec; 16(8):1150-5. PubMed ID: 24326168
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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]  

  • 6. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).
    Gnanasakthy A; DeMuro C; Clark M; Haydysch E; Ma E; Bonthapally V
    J Clin Oncol; 2016 Jun; 34(16):1928-34. PubMed ID: 27069082
    [TBL] [Abstract][Full Text] [Related]  

  • 7. 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]  

  • 8. Patient-Reported Outcomes in Orphan Drug Labels Approved by the US Food and Drug Administration.
    Hong YD; Villalonga-Olives E; Perfetto EM
    Value Health; 2019 Aug; 22(8):925-930. PubMed ID: 31426934
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Patient-reported outcomes supporting anticancer product approvals.
    Rock EP; Kennedy DL; Furness MH; Pierce WF; Pazdur R; Burke LB
    J Clin Oncol; 2007 Nov; 25(32):5094-9. PubMed ID: 17991927
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency.
    Bottomley A; Jones D; Claassens L
    Eur J Cancer; 2009 Feb; 45(3):347-53. PubMed ID: 19013787
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union.
    Clark MJ; Harris N; Griebsch I; Kaschinski D; Copley-Merriman C
    Health Qual Life Outcomes; 2014 Jul; 12():104. PubMed ID: 24989428
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.
    Frueh FW; Amur S; Mummaneni P; Epstein RS; Aubert RE; DeLuca TM; Verbrugge RR; Burckart GJ; Lesko LJ
    Pharmacotherapy; 2008 Aug; 28(8):992-8. PubMed ID: 18657016
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges.
    Hao Y
    Expert Rev Pharmacoecon Outcomes Res; 2010 Aug; 10(4):407-20. PubMed ID: 20715918
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.
    Sridhara R; Johnson JR; Justice R; Keegan P; Chakravarty A; Pazdur R
    J Natl Cancer Inst; 2010 Feb; 102(4):230-43. PubMed ID: 20118413
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Challenges to use of health-related quality of life for Food and Drug Administration approval of anticancer products.
    Rock EP; Scott JA; Kennedy DL; Sridhara R; Pazdur R; Burke LB
    J Natl Cancer Inst Monogr; 2007; (37):27-30. PubMed ID: 17951228
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Assessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): searching for standards.
    Cleeland CS; Sloan JA;
    J Pain Symptom Manage; 2010 Jun; 39(6):1077-85. PubMed ID: 20538189
    [TBL] [Abstract][Full Text] [Related]  

  • 17. US FDA patient-reported outcome guidance: great expectations and unintended consequences.
    Fehnel S; DeMuro C; McLeod L; Coon C; Gnanasakthy A
    Expert Rev Pharmacoecon Outcomes Res; 2013 Aug; 13(4):441-6. PubMed ID: 23977972
    [TBL] [Abstract][Full Text] [Related]  

  • 18. The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims.
    Coons SJ; Kothari S; Monz BU; Burke LB
    Clin Pharmacol Ther; 2011 Nov; 90(5):743-8. PubMed ID: 21993428
    [TBL] [Abstract][Full Text] [Related]  

  • 19. How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure.
    Brozek JL; Guyatt GH; Schünemann HJ
    Health Qual Life Outcomes; 2006 Sep; 4():69. PubMed ID: 17005037
    [TBL] [Abstract][Full Text] [Related]  

  • 20. A Review of Patient-Reported Outcome Labeling of FDA-Approved New Drugs (2016-2020): Counts, Categories, and Comprehensibility.
    Gnanasakthy A; Norcross L; DeMuro Romano C; Carson RT
    Value Health; 2022 Apr; 25(4):647-655. PubMed ID: 35365309
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 13.