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Grant Details

Grant Number: 5UC2CA148570-02 Interpret this number
Primary Investigator: Ramsey, Scott
Organization: Fred Hutchinson Cancer Research Center
Project Title: Center for Comparative Effectiveness Research in Cancer Genomics - Cancergen
Fiscal Year: 2010
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Abstract

DESCRIPTION (Provided by the applicant): A number of genomic applications for cancer have become available for assessing disease risk, prognosis, and drug response prediction, offering the promise of effective and efficient cancer care tailored to the genetic profile of the patient or disease - Genomics and Personalized Medicine (GPM). The current regulatory structure - which focuses on analytical accuracy rather than clinical validity or utility - creates a potential that genomic tests will be introduced into clinical practice without sufficient evidence supporting their value compared to standard care, or conversely that tests that provide high clinical utility and value will not be utilized or reimbursed in practice. In many cases, evidence from randomized controlled trials (RCTs) will be needed to establish clinical value. To provide useful information for decision makers, such trials will need to extend beyond traditional designs to include patient outcomes and economic evaluation. In addition, greater use of trial designs that more closely represent clinical practice, such as pragmatic trials, are needed. The National Cancer Institute (NCI)-supported cancer clinical trials Cooperative Group Program offers a compelling infrastructure for the conduct of high-quality prospective comparative effectiveness research (CER) studies of GPM applications for cancer. To maximize the impact of this infrastructure on cancer practice, it is also critical to develop methods for identifying CER topics in cancer genomics that are priorities from multiple stakeholder perspectives. In addition, to address the challenge of making innovative GPM technologies available to patients while at the same time generating high quality evidence needed by decision makers, novel shared funding mechanisms such as Coverage with Evidence Development (CED) are needed. We propose to develop a Center for Comparative Effectiveness Research in Cancer Genomics (CANCERGEN), a sustainable, multidisciplinary, collaborative consortium including the Fred Hutchinson Cancer Research Center, the Center for Medical Technology Policy, University of Washington, and the Southwest Oncology Group, one of the largest of the National Cancer Institute-supported cancer clinical trials cooperative groups in the United States. CANCERGEN will integrate expertise in decision modeling, database linkage, ethics, policy, and clinical trial design in order to leverage and build upon the existing strengths of the SWOG clinical trials network to facilitate the rapid design and implementation of prospective CER studies of GPM technologies. Moreover, CANCERGEN will create a unique and valuable partnership with the Center for Medical Technology Policy, whereby multidisciplinary stakeholders will collaborate with CANCERGEN to identify research priorities. Our vision is that CANCERGEN will overcome structural barriers that have limited the quality and timeliness of evaluations in GPM, with the result that promising technologies in the cancer genomics pipeline can move rapidly from "proof of principle" to improving the effectiveness and costeffectiveness of cancer clinical care. PUBLIC HEALTH RELEVANCE: A variety of genomic and personalized medicine applications for cancer offer the promise of improved cancer care, but the process by which genomic tests move from development to market availability rarely generates high quality evidence supporting their clinical utility or economic value. To address this problem, we will create a Center that includes researchers from the Fred Hutchinson Cancer Research Center, the Center for Medical Technology Policy, the University of Washington, and the Southwest Oncology Group, one of the largest of the National Cancer Institute-supported cancer clinical trials cooperative groups in the United States. This collaborative network will overcome barriers that have limited the quality and timeliness of evaluations in genomics and personalized medicine, with the result that promising technologies currently in the cancer genomics pipeline can move rapidly from "proof of principle" to improving the effectiveness and cost effectiveness of cancer clinical care to benefit public health.

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Publications

Tumor marker usage and medical care costs among older early-stage breast cancer survivors.
Authors: Ramsey S.D. , Henry N.L. , Gralow J.R. , Mirick D.K. , Barlow W. , Etzioni R. , Mummy D. , Thariani R. , Veenstra D.L. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015-01-10; 33(2), p. 149-55.
EPub date: 2014-10-20.
PMID: 25332254
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A new model for reimbursing genome-based cancer care.
Authors: Ramsey S.D. , Sullivan S.D. .
Source: The oncologist, 2014 Jan; 19(1), p. 1-4.
EPub date: 2013-12-05.
PMID: 24309984
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Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis.
Authors: Thariani R. , Henry N.L. , Ramsey S.D. , Blough D.K. , Barlow B. , Gralow J.R. , Veenstra D.L. .
Source: Journal of comparative effectiveness research, 2013 May; 2(3), p. 325-34.
PMID: 24236631
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Value-of-information analysis within a stakeholder-driven research prioritization process in a US setting: an application in cancer genomics.
Authors: Carlson J.J. , Thariani R. , Roth J. , Gralow J. , Henry N.L. , Esmail L. , Deverka P. , Ramsey S.D. , Baker L. , Veenstra D.L. .
Source: Medical decision making : an international journal of the Society for Medical Decision Making, 2013 05; 33(4), p. 463-71.
PMID: 23635833
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Getting our priorities straight: a novel framework for stakeholder-informed prioritization of cancer genomics research.
Authors: Esmail L.C. , Roth J. , Rangarao S. , Carlson J.J. , Thariani R. , Ramsey S.D. , Veenstra D.L. , Deverka P. .
Source: Genetics in medicine : official journal of the American College of Medical Genetics, 2013 Feb; 15(2), p. 115-22.
EPub date: 2012-10-04.
PMID: 23037935
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Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trial (SWOG S1007) evaluating oncotypeDX-guided management for women with breast cancer involving lymph nodes.
Authors: Ramsey S.D. , Barlow W.E. , Gonzalez-Angulo A.M. , Tunis S. , Baker L. , Crowley J. , Deverka P. , Veenstra D. , Hortobagyi G.N. .
Source: Contemporary clinical trials, 2013 Jan; 34(1), p. 1-9.
EPub date: 2012-09-18.
PMID: 23000081
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Improving the efficiency and relevance of evidence-based recommendations in the era of whole-genome sequencing: an EGAPP methods update.
Authors: Veenstra D.L. , Piper M. , Haddow J.E. , Pauker S.G. , Klein R. , Richards C.S. , Tunis S.R. , Djulbegovic B. , Marrone M. , Lin J.S. , et al. .
Source: Genetics in medicine : official journal of the American College of Medical Genetics, 2013 Jan; 15(1), p. 14-24.
EPub date: 2012-09-06.
PMID: 22955111
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The value of comparative effectiveness research: projected return on investment of the RxPONDER trial (SWOG S1007).
Authors: Wong W.B. , Ramsey S.D. , Barlow W.E. , Garrison L.P. , Veenstra D.L. .
Source: Contemporary clinical trials, 2012 Nov; 33(6), p. 1117-23.
EPub date: 2012-08-18.
PMID: 22981891
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Facilitating comparative effectiveness research in cancer genomics: evaluating stakeholder perceptions of the engagement process.
Authors: Deverka P.A. , Lavallee D.C. , Desai P.J. , Armstrong J. , Gorman M. , Hole-Curry L. , O'Leary J. , Ruffner B.W. , Watkins J. , Veenstra D.L. , et al. .
Source: Journal of comparative effectiveness research, 2012 Jul; 1(4), p. 359-70.
PMID: 23459832
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Building the evidence base for decision making in cancer genomic medicine using comparative effectiveness research.
Authors: Goddard K.A. , Knaus W.A. , Whitlock E. , Lyman G.H. , Feigelson H.S. , Schully S.D. , Ramsey S. , Tunis S. , Freedman A.N. , Khoury M.J. , et al. .
Source: Genetics in medicine : official journal of the American College of Medical Genetics, 2012 Jul; 14(7), p. 633-42.
PMID: 22516979
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Stakeholder assessment of the evidence for cancer genomic tests: insights from three case studies.
Authors: Deverka P.A. , Schully S.D. , Ishibe N. , Carlson J.J. , Freedman A. , Goddard K.A. , Khoury M.J. , Ramsey S.D. .
Source: Genetics in medicine : official journal of the American College of Medical Genetics, 2012 Jul; 14(7), p. 656-62.
PMID: 22481130
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Prioritization in comparative effectiveness research: the CANCERGEN Experience.
Authors: Thariani R. , Wong W. , Carlson J.J. , Garrison L. , Ramsey S. , Deverka P.A. , Esmail L. , Rangarao S. , Hoban C.J. , Baker L.H. , et al. .
Source: Medical care, 2012 May; 50(5), p. 388-93.
PMID: 22274803
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Paying for personalized care: cancer biomarkers and comparative effectiveness.
Authors: Thariani R. , Veenstra D.L. , Carlson J.J. , Garrison L.P. , Ramsey S. .
Source: Molecular oncology, 2012 Apr; 6(2), p. 260-6.
EPub date: 2012-03-06.
PMID: 22429896
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Stakeholder participation in comparative effectiveness research: defining a framework for effective engagement.
Authors: Deverka P.A. , Lavallee D.C. , Desai P.J. , Esmail L.C. , Ramsey S.D. , Veenstra D.L. , Tunis S.R. .
Source: Journal of comparative effectiveness research, 2012 Mar; 1(2), p. 181-194.
PMID: 22707880
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How comparative effectiveness research can help advance 'personalized medicine' in cancer treatment.
Authors: Ramsey S.D. , Veenstra D. , Tunis S.R. , Garrison L. , Crowley J.J. , Baker L.H. .
Source: Health affairs (Project Hope), 2011 Dec; 30(12), p. 2259-68.
PMID: 22147853
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Prognostic role of ERCC1 in advanced non-small-cell lung cancer: a systematic review and meta-analysis.
Authors: Roth J.A. , Carlson J.J. .
Source: Clinical lung cancer, 2011 Nov; 12(6), p. 393-401.
EPub date: 2011-07-01.
PMID: 21723790
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Evolving research and stakeholder perspectives on pharmacogenomics.
Authors: Beitelshees A.L. , Veenstra D.L. .
Source: JAMA, 2011-09-21; 306(11), p. 1252-3.
PMID: 21934059
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Cost effectiveness of pharmacogenomics: a critical and systematic review.
Authors: Wong W.B. , Carlson J.J. , Thariani R. , Veenstra D.L. .
Source: PharmacoEconomics, 2010; 28(11), p. 1001-13.
PMID: 20936884
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