Building the evidence base for decision making in cancer genomic medicine using comparative effectiveness research

Katrina A B Goddard, William A. Knaus, Evelyn Whitlock, Gary H. Lyman, Heather Spencer Feigelson, Sheri D. Schully, Scott Ramsey, Sean Tunis, Andrew N. Freedman, Muin J. Khoury, David L. Veenstra

Research output: Contribution to journalArticlepeer-review

Abstract

The clinical utility is uncertain for many cancer genomic applications. Comparative effectiveness research (CER) can provide evidence to clarify this uncertainty. The aim of this study was to identify approaches to help stakeholders make evidence-based decisions and to describe potential challenges and opportunities in using CER to produce evidence-based guidance. We identified general CER approaches for genomic applications through literature review, the authors experiences, and lessons learned from a recent, seven-site CER initiative in cancer genomic medicine. Case studies illustrate the use of CER approaches. Evidence generation and synthesis approaches used in CER include comparative observational and randomized trials, patient-reported outcomes, decision modeling, and economic analysis. Significant challenges to conducting CER in cancer genomics include the rapid pace of innovation, lack of regulation, and variable definitions and evidence thresholds for clinical and personal utility. Opportunities to capitalize on CER methods in cancer genomics include improvements in the conduct of evidence synthesis, stakeholder engagement, increasing the number of comparative studies, and developing approaches to inform clinical guidelines and research prioritization. CER offers a variety of methodological approaches that can address stakeholders needs and help ensure an effective translation of genomic discoveries.

Original languageEnglish (US)
Pages (from-to)633-642
Number of pages10
JournalGenetics in Medicine
Volume14
Issue number7
DOIs
StatePublished - Jul 2012
Externally publishedYes

Keywords

  • clinical utility
  • evidence generation
  • evidence synthesis
  • stakeholder

ASJC Scopus subject areas

  • Genetics(clinical)

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