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 *

2644 related articles for article (PubMed ID: 17034633)

  • 1. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.
    ; ;
    Health Qual Life Outcomes; 2006 Oct; 4():79. PubMed ID: 17034633
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report.
    Coons SJ; Gwaltney CJ; Hays RD; Lundy JJ; Sloan JA; Revicki DA; Lenderking WR; Cella D; Basch E;
    Value Health; 2009 Jun; 12(4):419-29. PubMed ID: 19900250
    [TBL] [Abstract][Full Text] [Related]  

  • 3. 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]  

  • 4. 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]  

  • 5. A concept taxonomy and an instrument hierarchy: tools for establishing and evaluating the conceptual framework of a patient-reported outcome (PRO) instrument as applied to product labeling claims.
    Erickson P; Willke R; Burke L
    Value Health; 2009; 12(8):1158-67. PubMed ID: 19744289
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Patient-reported outcomes to support medical product labeling claims: FDA perspective.
    Patrick DL; Burke LB; Powers JH; Scott JA; Rock EP; Dawisha S; O'Neill R; Kennedy DL
    Value Health; 2007; 10 Suppl 2():S125-37. PubMed ID: 17995471
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Patient-reported outcomes: conceptual issues.
    Rothman ML; Beltran P; Cappelleri JC; Lipscomb J; Teschendorf B;
    Value Health; 2007; 10 Suppl 2():S66-75. PubMed ID: 17995476
    [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. Patient-reported outcome instrument selection: designing a measurement strategy.
    Snyder CF; Watson ME; Jackson JD; Cella D; Halyard MY;
    Value Health; 2007; 10 Suppl 2():S76-85. PubMed ID: 17995477
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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
    Qual Life Res; 2007 May; 16(4):717-23. PubMed ID: 17268927
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Patient-Reported Outcomes in Chronic Heart Failure: Applicability for Regulatory Approval.
    Psotka MA; von Maltzahn R; Anatchkova M; Agodoa I; Chau D; Malik FI; Patrick DL; Spertus JA; Wiklund I; Teerlink JR
    JACC Heart Fail; 2016 Oct; 4(10):791-804. PubMed ID: 27395351
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force.
    Matza LS; Patrick DL; Riley AW; Alexander JJ; Rajmil L; Pleil AM; Bullinger M
    Value Health; 2013 Jun; 16(4):461-79. PubMed ID: 23796280
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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]  

  • 14. 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]  

  • 15. 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]  

  • 16. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report.
    Rothman M; Burke L; Erickson P; Leidy NK; Patrick DL; Petrie CD
    Value Health; 2009; 12(8):1075-83. PubMed ID: 19804437
    [TBL] [Abstract][Full Text] [Related]  

  • 17. A review of FDA warning letters and notices of violation issued for patient-reported outcomes promotional claims between 2006 and 2012.
    Symonds T; Hackford C; Abraham L
    Value Health; 2014 Jun; 17(4):433-7. PubMed ID: 24969004
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. Patient-Centered Research to Support the Development of the Symptoms of Major Depressive Disorder Scale (SMDDS): Initial Qualitative Research.
    McCarrier KP; Deal LS; Abraham L; Blum SI; Bush EN; Martin ML; Thase ME; Coons SJ;
    Patient; 2016 Apr; 9(2):117-34. PubMed ID: 26113249
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Pain palliation measurement in cancer clinical trials: the US Food and Drug Administration perspective.
    Basch E; Trentacosti AM; Burke LB; Kwitkowski V; Kane RC; Autio KA; Papadopoulos E; Stansbury JP; Kluetz PG; Smith H; Justice R; Pazdur R
    Cancer; 2014 Mar; 120(5):761-7. PubMed ID: 24375398
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 133.