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CCR Perspectives in Regulatory Science and Policy

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms

Paul G. Kluetz, Ashley Slagle, Elektra J. Papadopoulos, Laura Lee Johnson, Martha Donoghue, Virginia E. Kwitkowski, Wen-Hung Chen, Rajeshwari Sridhara, Ann T. Farrell, Patricia Keegan, Geoffrey Kim and Richard Pazdur
Paul G. Kluetz
1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • For correspondence: paul.kluetz@fda.hhs.gov
Ashley Slagle
2Clinical Outcome Assessment Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Elektra J. Papadopoulos
2Clinical Outcome Assessment Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Laura Lee Johnson
3Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Martha Donoghue
1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Virginia E. Kwitkowski
1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Wen-Hung Chen
2Clinical Outcome Assessment Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Rajeshwari Sridhara
3Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Ann T. Farrell
1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Patricia Keegan
1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Geoffrey Kim
1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Richard Pazdur
1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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DOI: 10.1158/1078-0432.CCR-15-2035 Published April 2016
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Article Information

Volume 22, Issue 7, pp. 1553-1558

DOI 
https://doi.org/10.1158/1078-0432.CCR-15-2035
PubMed 
26758559

Published By 
American Association for Cancer Research
Print ISSN 
1078-0432
Online ISSN 
1557-3265
History 
  • Received November 13, 2015
  • Revision received December 22, 2015
  • Accepted December 24, 2015
  • Published first January 12, 2016.

Article Versions

  • Previous version (January 12, 2016 - 10:19).
  • You are viewing the most recent version of this article.
Copyright & Usage 
©2016 American Association for Cancer Research.

Author Information

  1. Paul G. Kluetz1,*,
  2. Ashley Slagle2,
  3. Elektra J. Papadopoulos2,
  4. Laura Lee Johnson3,
  5. Martha Donoghue1,
  6. Virginia E. Kwitkowski1,
  7. Wen-Hung Chen2,
  8. Rajeshwari Sridhara3,
  9. Ann T. Farrell1,
  10. Patricia Keegan1,
  11. Geoffrey Kim1, and
  12. Richard Pazdur1
  1. 1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  2. 2Clinical Outcome Assessment Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  3. 3Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  1. ↵*Corresponding Author:
    Paul G. Kluetz, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, WO22 Room 2223, Silver Spring, MD 20993. E-mail: paul.kluetz{at}fda.hhs.gov
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Clinical Cancer Research: 22 (7)
April 2016
Volume 22, Issue 7
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Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms
Paul G. Kluetz, Ashley Slagle, Elektra J. Papadopoulos, Laura Lee Johnson, Martha Donoghue, Virginia E. Kwitkowski, Wen-Hung Chen, Rajeshwari Sridhara, Ann T. Farrell, Patricia Keegan, Geoffrey Kim and Richard Pazdur
Clin Cancer Res April 1 2016 (22) (7) 1553-1558; DOI: 10.1158/1078-0432.CCR-15-2035

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Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms
Paul G. Kluetz, Ashley Slagle, Elektra J. Papadopoulos, Laura Lee Johnson, Martha Donoghue, Virginia E. Kwitkowski, Wen-Hung Chen, Rajeshwari Sridhara, Ann T. Farrell, Patricia Keegan, Geoffrey Kim and Richard Pazdur
Clin Cancer Res April 1 2016 (22) (7) 1553-1558; DOI: 10.1158/1078-0432.CCR-15-2035
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