Development and validation of eleven symptom indexes to evaluate response to chemotherapy for advanced cancer: Measurement compliance with regulatory demands

Sarah Rosenbloom, Susan Yount, Kathleen Yost, Debra Hampton, Diane Paul, Amy Abernethy, Paul B. Jacobsen, Karen Syrjala, Jamie Von Roenn, David Cella

Research output: Chapter in Book/Report/Conference proceedingChapter

1 Scopus citations

Abstract

Recent guidance from the United States Food and Drug Administration discusses patient-reported outcomes as endpoints in clinical trials (FDA, 2006). Using methods consistent with this guidance, we developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from National Comprehensive Cancer Network (NCCN) member institutions and four non-profit social service organizations. Diagnoses included the following 11 primary cancers: bladder, brain, breast, colorectal, head/neck, hepatobiliary/pancreatic, kidney, lung, lymphoma, ovarian and prostate. Physician experts in each of 11 diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results were evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also at NCCN institutions (Cella et al., 2003). The final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.

Original languageEnglish (US)
Title of host publicationThe Value of Innovation
Subtitle of host publicationImpact on Health, Life Quality, Safety, and Regulatory Research
EditorsIrina Farquhar, Kent Summers, Alan Sorkin
Pages53-66
Number of pages14
DOIs
StatePublished - Oct 20 2008

Publication series

NameResearch in Human Capital and Development
Volume16
ISSN (Print)0194-3960

ASJC Scopus subject areas

  • Demography
  • Development
  • Industrial relations
  • Economics and Econometrics
  • Political Science and International Relations

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