Should patient-reported outcomes be mandatory for toxicity reporting in cancer clinical trials?

Journal of Clinical Oncology

Volumn 25, Issue 34, 2007, Pages 5345-5347

  Bruner, Deborah Watkins ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CANCER RESEARCH; CLINICAL RESEARCH; DRUG SURVEILLANCE PROGRAM; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HEALTH STATUS; HUMAN; MANDATORY REPORTING; PATIENT ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; SELF REPORT; WORLD HEALTH ORGANIZATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS; ONLINE SYSTEMS; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SATISFACTION;

EID: 36849048158     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.13.3330     Document Type: Editorial

References (17)

1. Parliament M, Danjoux C, Clayton T: Is cancer treatment toxicity accurately reported? Int J Radiat Oncol Biol Phys 11:603-608, 1985
2. Varricchio CG, Sloan JA: The need for and characteristics of randomized, phase III trials to evaluate symptom management in patients with cancer. J Natl Cancer Inst 94:1184-1185, 2002
3. US Department of Health and Human Services: Guidance for industry: Patient-reported outcomes measures - Use in medical product development to support labeling claims, 2006. http://www.fda.gov/cder/guidance/5460dft.pdf
4. Basch E, Iasonos A, Barz A, et al: Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy. J Clin Oncol 25:5374-5380, 2007
5. Basch E, Artz D, Iasonos A, et al: Evaluation of an online platform for cancer patient self-reporting of chemotherapy toxicities. J Am Med Inform Assoc 14:264-268, 2007
6. Trotti A, Pajak T, Gwede CK, et al: TAME: Development of a new method for summarising adverse events of cancer treatment by the Radiation Therapy Oncology Group. Lancet Oncol 8:613-624, 2007
7. Brundage MD, Pater JL, Zee B: Assessing the reliability of two toxicity scales: Implications for interpreting toxicity data. J Natl Cancer Inst 85:1138-1148, 1993
8. Kaba H, Fukuda H, Yamamoto S, et al: Reliability at the National Cancer Institute-Common Toxicity Criteria version 2.0. Gan To Kagaku Ryoho 31:1187-1192, 2004
9. Movsas B, Scott C, Langer C, et al: Randomized trial of amifostine in locally advanced non-small-cell lung cancer patients receiving chemotherapy and hyperfractionated radiation: Radiation Therapy Oncology Group trial 98-01. J Clin Oncol 23:2145-2154, 2005
10. Bruner DW, Scott C, Lawton C, et al: RTOG's first quality of life study-RTOG 90-20: A phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer. Int J Radiat Oncol Biol Phys 33:901-906, 1995
11. Jensen MP: The validity and reliability of pain measures in adults with cancer. J Pain 4:2-21, 2003
12. Bruner DW: Outcomes research in cancer symptom management trials: The Radiation Oncology Group (RTOG) Conceptual Model. J Natl Cancer Inst (in press)
13. Langendijk H, Aaronson N, de Jong J, et al: The prognostic impact of quality of life assessed with the EORTC QLQ-C30 in inoperable non-small cell lung carcinoma treated with radiotherapy. Radiother Oncol 55:19-25, 2000
14. Fang F, Tsai W, Chiu H, et al: Quality of life as a survival predictor for esophageal squamous cell carcinoma treated with radiotherapy. Int J Radiat Oncol Biol Phys 58:1394-1404, 2004
15. Monk B, Huang H, Cella D, et al: Quality of life outcomes from a randomized phase III trial of cisplatin with or without topotecan in advanced carcinoma of the cervix: A Gynecologic Oncology Group study. J Clin Oncol 23:4617-4625, 2005
16. Efficace F, Biganzoli L, Piccart M, et al: Baseline health-related quality-of-life data as prognostic factors in a phase III multicentre study of women with metastatic breast cancer. Eur J Cancer 40:1021-1030, 2004
17. Roychowdhury D, Hayden A, Liepa A: Health-related quality-of-life parameters as independent prognostic factors in advanced or metastatic bladder cancer. J Clin Oncol 21:673-678, 2003