• Veenstra D
  • Thariani R
  • Carlson J
  • et al.
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OBJECTIVES: The Center for Comparative Effectiveness Research in Cancer Genomics (CANCERGEN) is a multidisciplinary, national consortium established to conduct CER in Genomics and Personalized Medicine (GPM). The objective was the evaluation and prioritization of GPM applications for study in a prospective, randomized CER trial. METHODS: Candidate GPMs were identified through a landscape analysis of recent literature. Initial candidates were examined by cancer genomics experts and study investigators to identify 5-7 GPMs for evaluation by a diverse group of external stakeholders, including representatives from patients groups, payers, test developers, state-funded public HTA programs, and practicing oncologists. We developed Topic Briefs and Test Target Profiles assessing the following domains: population impact, current standard of care, clinical validity, potential benefits, potential harms, economic impact, evidence of need, trial feasibility, and current payer status. RESULTS: We identified 43 studies from 183 GPMs based on our landscape analysis, which were narrowed to four GPMs through feedback from cancer genomics experts; two additional GPMs were identified by investigators from our clinical trials consortium (SWOG). The six GPMs included: ERCC1 testing for platinum chemotherapy in NSCLC, EGFR mutation testing for TKIs in NSCLC maintenance, tumor markers for breast cancer recurrence, EGFR FISH testing for first-line cetuximab in NSCLC, BRAF testing in colorectal cancer, and gene expression profiling in multiple myeloma. External stakeholders preliminarily identified the first three of these as most likely providing the greatest value of research. CONCLUSIONS: A rapid process for research prioritization involving literature evaluation, expert input, and stakeholder feedback is feasible with adequate resources and processes. Elements include an organization facilitating collaboration between investigators with CER/clinical trials experience, and utilizing systematic and timely evidence-assessment accessible to stakeholders. Final selection of a GPM for study in a prospective CER trial will be based on quantitative value-of-information analyses, implementation feasibility, and funding mechanisms, including coverage with evidence development




Veenstra, D., Thariani, R., Carlson, J., Garrison, L., Mohr, P., Deverka, P., … Ramsey, S. (2010). PCN82 RESEARCH PRIORITIZATION FOR PROSPECTIVE COMPARATIVE EFFECTIVENESS RESEARCH (CER) IN CANCER GENOMICS. Value in Health, 13(7), A266. https://doi.org/10.1016/s1098-3015(11)71977-5

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