메뉴 건너뛰기




Volumn 6, Issue 5, 2013, Pages

Patient-reported outcomes are changing the landscape in oncology care: Challenges and opportunities for payers

Author keywords

[No Author keywords available]

Indexed keywords

GEMCITABINE; IMATINIB; IRINOTECAN; LEUPRORELIN; MITOXANTRONE; PACLITAXEL; PLACEBO; RUXOLITINIB;

EID: 84880582346     PISSN: 19422962     EISSN: 19422970     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (48)

References (25)
  • 2
    • 9944234591 scopus 로고    scopus 로고
    • Measuring treatment impact: A review of patient-reported outcomes and other efficacy endpoints in approved product labels
    • Willke RJ, Burke LB, Erickson P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Control Clin Trials. 2004;25:535-552.
    • (2004) Control Clin Trials. , vol.25 , pp. 535-552
    • Willke, R.J.1    Burke, L.B.2    Erickson, P.3
  • 3
    • 79960017594 scopus 로고    scopus 로고
    • The role of health-related quality of life data in the drug approval processes in the US and Europe: A review of guidance documents and authorizations of medicinal products from 2006 to 2010
    • Marquis P, Caron M, Emery M, et al. The role of health-related quality of life data in the drug approval processes in the US and Europe: a review of guidance documents and authorizations of medicinal products from 2006 to 2010. Pharm Med. 2011;25:147-160.
    • (2011) Pharm Med. , vol.25 , pp. 147-160
    • Marquis, P.1    Caron, M.2    Emery, M.3
  • 4
    • 84861163178 scopus 로고    scopus 로고
    • A review of patient-reported outcome labels in the United States: 2006 to 2010
    • Gnanasakthy A, Mordin M, Clark M, et al. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value Health. 2012;15:437-442.
    • (2012) Value Health. , vol.15 , pp. 437-442
    • Gnanasakthy, A.1    Mordin, M.2    Clark, M.3
  • 5
    • 77955823761 scopus 로고    scopus 로고
    • Patient-reported outcomes in support of oncology product labeling claims: Regulatory context and challenges
    • Hao Y. Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges. Expert Rev Pharmacoecon Outcomes Res. 2010;10: 407-420.
    • (2010) Expert Rev Pharmacoecon Outcomes Res. , vol.10 , pp. 407-420
    • Hao, Y.1
  • 6
    • 55849105920 scopus 로고    scopus 로고
    • Grasping the FDA's PRO guidance: What the agency requires to support the selection of patient-reported outcome instruments
    • Shields A, Gwaltney C, Tiplady B, et al. Grasping the FDA's PRO guidance: what the agency requires to support the selection of patient-reported outcome instruments. Applied Clin Trials. 2006;15:69-77.
    • (2006) Applied Clin Trials. , vol.15 , pp. 69-77
    • Shields, A.1    Gwaltney, C.2    Tiplady, B.3
  • 7
    • 66249107028 scopus 로고    scopus 로고
    • 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, et al. 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. Value Health. 2009;12:419-429.
    • (2009) Value Health. , vol.12 , pp. 419-429
    • Coons, S.J.1    Gwaltney, C.J.2    Hays, R.D.3
  • 8
    • 70350751583 scopus 로고    scopus 로고
    • 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, et al. 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. Value Health. 2009;12:1075-1083.
    • (2009) Value Health. , vol.12 , pp. 1075-1083
    • Rothman, M.1    Burke, L.2    Erickson, P.3
  • 9
    • 80055007179 scopus 로고    scopus 로고
    • 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
    • Patrick DL, Burke LB, Gwaltney CJ, et al. 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. Value Health. 2011;14:967-977.
    • (2011) Value Health. , vol.14 , pp. 967-977
    • Patrick, D.L.1    Burke, L.B.2    Gwaltney, C.J.3
  • 10
    • 82955193739 scopus 로고    scopus 로고
    • 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 II-assessing respondent understanding
    • Patrick DL, Burke LB, Gwaltney CJ, et al. 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 II-assessing respondent understanding. Value Health. 2011;14:578-588.
    • (2011) Value Health. , vol.14 , pp. 578-588
    • Patrick, D.L.1    Burke, L.B.2    Gwaltney, C.J.3
  • 11
    • 36849066178 scopus 로고    scopus 로고
    • Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks
    • Bruner DW, Bryan CJ, Aaronson N, et al. Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. J Clin Oncol. 2007;25:5051-5057.
    • (2007) J Clin Oncol. , vol.25 , pp. 5051-5057
    • Bruner, D.W.1    Bryan, C.J.2    Aaronson, N.3
  • 12
    • 36849000198 scopus 로고    scopus 로고
    • Current status of patient--reported outcomes in industry-sponsored oncology clinical trials and product labels
    • Gondek K, Sagnier PP, Gilchrist K, Woolley JM. Current status of patient--reported outcomes in industry-sponsored oncology clinical trials and product labels. J Clin Oncol. 2007;25:5087-5093.
    • (2007) J Clin Oncol. , vol.25 , pp. 5087-5093
    • Gondek, K.1    Sagnier, P.P.2    Gilchrist, K.3    Woolley, J.M.4
  • 13
    • 0037986306 scopus 로고    scopus 로고
    • End points and United States Food and Drug Administration approval of oncology drugs
    • Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol. 2003;21:1404-1411.
    • (2003) J Clin Oncol. , vol.21 , pp. 1404-1411
    • Johnson, J.R.1    Williams, G.2    Pazdur, R.3
  • 14
  • 15
    • 36849021996 scopus 로고    scopus 로고
    • Patient-reported outcomes assessment in cancer trials: Taking stock, moving forward
    • Lipscomb J, Reeve BB, Clauser SB, et al. Patient-reported outcomes assessment in cancer trials: taking stock, moving forward. J Clin Oncol. 2007;25:5133-5140.
    • (2007) J Clin Oncol. , vol.25 , pp. 5133-5140
    • Lipscomb, J.1    Reeve, B.B.2    Clauser, S.B.3
  • 17
    • 84880609090 scopus 로고    scopus 로고
    • Research Triangle Park, NC: GlaxoSmithKline
    • Hycamtin [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2010.
    • (2010) Hycamtin [prescribing information]
  • 18
    • 0033044111 scopus 로고    scopus 로고
    • Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer
    • von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999;17:658-667.
    • (1999) J Clin Oncol. , vol.17 , pp. 658-667
    • von Pawel, J.1    Schiller, J.H.2    Shepherd, F.A.3
  • 19
    • 84862538656 scopus 로고    scopus 로고
    • US Food and Drug Administration approval: Ruxolitinib for the treatment of patients with intermediate and high risk myelofibrosis
    • Deisseroth A, Kaminskas E, Grillo J, et al. US Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high risk myelofibrosis. Clin Cancer Res. 2012;18:3212-3217.
    • (2012) Clin Cancer Res. , vol.18 , pp. 3212-3217
    • Deisseroth, A.1    Kaminskas, E.2    Grillo, J.3
  • 20
    • 84880630988 scopus 로고    scopus 로고
    • Wilmington, DE: Incyte Corporation
    • Jakafi [prescribing information]. Wilmington, DE: Incyte Corporation; 2012.
    • (2012) Jakafi [prescribing information]
  • 21
    • 63849328927 scopus 로고    scopus 로고
    • New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment
    • Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113:2895-2901.
    • (2009) Blood. , vol.113 , pp. 2895-2901
    • Cervantes, F.1    Dupriez, B.2    Pereira, A.3
  • 23
    • 67549104035 scopus 로고    scopus 로고
    • The Myelofibrosis Symptom Assessment Form (MFSAF): An evidence-based brief inventory to measure quality of life and symptomatic response to treatment in myelofibrosis
    • Mesa RA, Schwager S, Radia D, et al. The Myelofibrosis Symptom Assessment Form (MFSAF): an evidence-based brief inventory to measure quality of life and symptomatic response to treatment in myelofibrosis. Leuk Res. 2009;33:1199-1203.
    • (2009) Leuk Res. , vol.33 , pp. 1199-1203
    • Mesa, R.A.1    Schwager, S.2    Radia, D.3
  • 24
    • 38449102936 scopus 로고    scopus 로고
    • Challenges to use of health-related quality of life for Food and Drug Administration approval of anticancer products
    • Rock EP, Scott JA, Kennedy DL, et al. Challenges to use of health-related quality of life for Food and Drug Administration approval of anticancer products. J Natl Cancer Inst Monogr. 2007;37:27-30.
    • (2007) J Natl Cancer Inst Monogr. , vol.37 , pp. 27-30
    • Rock, E.P.1    Scott, J.A.2    Kennedy, D.L.3
  • 25
    • 84880610916 scopus 로고    scopus 로고
    • Patient-reported outcomes in oncology focus group. April 17, Unpublished data
    • Xcenda. Patient-reported outcomes in oncology focus group. April 17, 2012. Unpublished data.
    • (2012) Xcenda


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.