The use and reporting of patient-reported outcomes in phase III breast cancer trials

Clinical Trials

Volumn 10, Issue 2, 2013, Pages 243-249

  Brim, Remy L ^a   Pearson, Steven D ^a,b  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; BREAST CANCER; CANCER STAGING; DRUG INDUSTRY; HUMAN; METASTASIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RETROSPECTIVE STUDY;

BREAST NEOPLASMS; CLINICAL TRIALS, PHASE III AS TOPIC; DATA COLLECTION; DRUG INDUSTRY; FEMALE; HUMANS; NEOPLASM STAGING; PATIENT-CENTERED CARE; RESEARCH DESIGN; SELF REPORT;

EID: 84876590938     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774513475529     Document Type: Article

References (33)

1. Initial National Priorities for Comparative Effectiveness Research. Washington, DC: National Academies Press ; 2009 :
2. The Patient-Centered Outcomes Research Institute. Available at: www.pcori.org (accessed 27 September 2011).
3. Adamowicz K, Jassem J, Katz A, Saad ED. Assessment of quality of life in advanced breast cancer. An overview of randomized phase III trials. Cancer Treat Rev. 2011 ; 38: 554-58
4. Joly F, Vardy J, Pintilie M, Tannock IF. Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer. Ann Oncol. 2007 ; 18: 1935-42
5. Mullins C, Montgomery R, Tunis S Effectiveness Guidance Document: Proposed Recommendations for Designing Clinical Trials for 'New Indications' of Approved Oncology Drugs for Treatment of Late Stage Disease. Baltimore, MD: Center for Medical Technology Policy ; 2010 :
6. Lipscomb J, Reeve BB, Clauser SB, et al. Patient-reported outcomes assessment in cancer trials: Taking stock, moving forward. J Clin Oncol. 2007 ; 25: 5133-40
7. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Food and Drug Administration. Silver Spring, MD: Food and Drug Administration ; 2009 :
8. Basch E, Abernethy A, Mullins CD, Spencer M Recommendations for Incorporating Patient-Reported Outcomes into the Design of Clinical Trials in Adult Oncology. Baltimore, MD: Center for Medical Technology Policy ; 2011 :
9. Howlader N, Noone AM, Krapcho M, et al Bethesda, MD: National Cancer Institute ; 2011 :
10. Goodwin PJ, Black JT, Bordeleau LJ, Ganz PA. Health-related quality-of-life measurement in randomized clinical trials in breast cancer - taking stock. J Natl Cancer Inst. 2003 ; 95: 263-81
11. Lemieux J, Goodwin PJ, Bordeleau LJ, Lauzier S, Théberge V. Quality-of-life measurement in randomized clinical trials in breast cancer: An updated systematic review (2001-2009). J Natl Cancer Inst. 2011 ; 103: 178-231
12. Montazeri A. Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007. J Exp Clin Cancer Res. 2008 ; 27: 32
13. 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: 5087-93
14. O'Mara AM, Denicoff AM. Health related quality of life in NCI-sponsored cancer treatment trials. Semin Oncol Nurs. 2010 ; 26: 68-78
15. Bruner DW, Bryan CJ, Aaronson N, et al. Issues andchallenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. J Clin Oncol. 2007 ; 25: 5051-57
16. Perry S, Kowalski TL, Chang CH. Quality of life assessment in women with breast cancer: Benefits, acceptability and utilization. Health Qual Life Outcomes. 2007 ; 5: 24
17. Moinpour CM, Denicoff AM, Bruner DW, et al. Funding patient-reported outcomes in cancer clinical trials. J Clin Oncol. 2007 ; 25: 5100-05
18. Basch E, Iasonos A, McDonough T, et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study. Lancet Oncol. 2006 ; 7: 903-09
19. Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010 ; 362: 865-69
20. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Available at: http://outcomes.cancer.gov/tools/pro- ctcae, 2012.
21. Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol. 2007 ; 25: 5121-27
22. Garcia SF, Cella D, Clauser SB, et al. Standardizing patient-reported outcomes assessment in cancer clinical trials: A patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007 ; 25: 5106-12
23. Cella D, Riley W, Stone A, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2006 ; 63: 1179-94
24. Gershon RC, Rothrock N, Hanrahan R, Bass M, Cella D. The use of PROMIS and assessment center to deliver patient-reported outcome measures in clinical research. J Appl Meas. 2010 ; 11: 304-14
25. Bren L. The importance of patient-reported outcomes... it's all about the patients. FDA Consum. 2006 ; 40: 27-32
26. Moinpour CM, Donaldson GW, Liepa AM, Sloan J. Evaluating health-related quality-of-life therapeutic effectiveness in a clinical trial with extensive nonignorable missing data and heterogeneous response: Results from a phase III randomized trial of gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer. Qual Life Res. 2011 ; 21: 765-75
27. Revicki D, Hays RD, Cella D, et al. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 ; 61: 102-09
28. Wyrwich KW, Bullinger M, Aaronson N, et al. Estimating clinically significant differences in quality of life outcomes. Qual Life Res. 2005 ; 14: 285-95
29. Ganz PA, Gotay CC. Use of patient-reported outcomes in phase III cancer treatment trials: Lessons learned and future directions. J Clin Oncol. 2007 ; 25: 5063-69
30. Law MR, Kawasumi Y, Morgan SG. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. Health Aff (Millwood). 2011 ; 30: 2338-45
31. Zarin DA, Ide NC, Tse T, et al. Issues in the registration of clinical trials. JAMA. 2007 ; 297: 2112-20
32. Califf RM, Zarin DA, Kramer JM, et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA. 2012 ; 307: 1838-47
33. Drazen JM, Zarin DA. Salvation by registration. N Engl J Med. 2007 ; 356: 184-85