Building the Evidence Base for Decision-making in Cancer Genomic Medicine Using Comparative Effectiveness Research

Details

• Alternative Title:
  Genet Med
• Personal Author:
  Goddard, Katrina A.B. ; Knaus, William A. ; Whitlock, Evelyn ; Lyman, Gary H. ; Feigelson, Heather Spencer ; Schully, Sheri D. ; Ramsey, Scott ; Tunis, Sean ; Freedman, Andrew N. ; Khoury, Muin J. ; Veenstra, David L.
• Description:
  Background
  
  The clinical utility is uncertain for many cancer genomic applications. Comparative effectiveness research (CER) can provide evidence to clarify this uncertainty.
  
  Objectives
  
  To identify approaches to help stakeholders make evidence-based decisions, and to describe potential challenges and opportunities using CER to produce evidence-based guidance.
  
  Methods
  
  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.
  
  Results
  
  Evidence generation and synthesis approaches include comparative observational and randomized trials, patient reported outcomes, decision modeling, and economic analysis. We identified significant challenges to conducting CER in cancer genomics: the rapid pace of innovation, the lack of regulation, the limited evidence for clinical utility, and the beliefs that genomic tests could have personal utility without having clinical 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.
  
  Conclusions
  
  CER offers a variety of methodological approaches to address stakeholders’ needs. Innovative approaches are needed to ensure an effective translation of genomic discoveries.
  
  
• Keywords:
  Clinical Utility Comparative Effectiveness Research Decision Making Evidence-Based Medicine Evidence Generation Evidence Synthesis Genomics Humans Neoplasms Randomized Controlled Trials As Topic Reproducibility Of Results Risk Assessment Stakeholder

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• Source:
  Genet Med. 14(7):633-642
• Pubmed ID:
  22516979
• Pubmed Central ID:
  PMC3632438
• Document Type:
  Journal Article
• Funding:
  U18 GD000005/GD/OGDP CDC HHSUnited States/ ; UC2CA150911/CA/NCI NIH HHSUnited States/ ; RC2 CA148570/CA/NCI NIH HHSUnited States/ ; RC2 CA148570-01/CA/NCI NIH HHSUnited States/ ; 5U18-GD000005-02/GD/OGDP CDC HHSUnited States/ ; RC2 CA148041/CA/NCI NIH HHSUnited States/ ; RC2 CA148471/CA/NCI NIH HHSUnited States/ ; RC2CA148570/CA/NCI NIH HHSUnited States/ ; RC2CA148041-01/CA/NCI NIH HHSUnited States/ ; P50HG003374/HG/NHGRI NIH HHSUnited States/ ; UC2 CA150911/CA/NCI NIH HHSUnited States/ ; UC2 CA148570/CA/NCI NIH HHSUnited States/ ; U01 GM092676/GM/NIGMS NIH HHSUnited States/ ; U18GD000005/GD/OGDP CDC HHSUnited States/ ; U01GM092676/GM/NIGMS NIH HHSUnited States/ ; UC2 CA148471/CA/NCI NIH HHSUnited States/ ; P50 HG003374/HG/NHGRI NIH HHSUnited States/
• Volume:
  14
• Issue:
  7
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:cc6fcec599d5ba7c004eab8686dec6e2ccc6634992938e7fb351c2e073f57422
• Download URL:
  https://stacks.cdc.gov/view/cdc/33545/cdc_33545_DS1.pdf
• File Type:
  [PDF - 74.75 KB ]