FRED HUTCHINSON CANCER RESEARCH CENTER

Numerous genomic applications for cancer have become available 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 focuses on analytical accuracy rather than clinical validity or utility and creates a potential that genomic tests will be introduced into clinical practice without sufficient evidence supporting their value compared to standard care, or that tests that provide high clinical utility and value will not be utilized or reimbursed in practice. In many cases, particularly for tests designed to inform cancer treatment decisions, evidence from randomized controlled trials (RCTs) will be needed to establish clinical value. To provide useful information for decision makers, trials will need to extend beyond traditional designs to include patient reported outcomes, economic evaluation, and input from multiple stakeholders and to more closely represent clinical practice. To address the need for sufficient evidence regarding the comparative effectiveness of these new genomic technologies, we propose to develop a Center for Comparative Effectiveness Research in Cancer Genomics (CANCERGEN), a multidisciplinary collaboration between the Fred Hutchinson Cancer Research Center (FHCRC), the Center for Medical Technology Policy (CMTP), University of Washington (UW), and the Southwest Oncology Group (SWOG), one of the largest of the National Cancer Institute-supported cancer clinical trials cooperative groups in the United States. The aims of this project are as follows: ? AIM 1: Establish CANCERGEN. CANCERGEN is envisioned to be a national leader in the fields of CER and policies to support appropriate use of GPM, and will support the framework of a sustainable, multi-center collaborative network of such organizations. CANCERGEN?s unique integration with the SWOG clinical trials network will complement other CER centers that are focusing on retrospective analysis of large datasets or collaborating with large health systems. The deliverable from this aim will be a manuscript describing the implementation process, structure, and function of the consortium. ? AIM 2: Within CANCERGEN, develop and implement comprehensive processes and methods for: (1) identifying high priority GPM technologies using a consensus process with multiple stakeholders; (2) evaluating those technologies using decision analytic techniques; (2) designing trials that meet the needs of multiple stakeholders; (4) conducting such trials through the SWOG infrastructure; and, (5) utilizing relationships with private and public health insurers to develop and implement CED designs through the SWOG research infrastructure. Studies will be designed in part to facilitate translation of findings into practice guidelines and cost-effective health insurer coverage policies. The deliverables from this aim will include a paper summarizing the consensus development process and a manuscript describing a study design for a prospective CER study to assess a high priority genomic and personalized medicine technology. ? AIM 3: CANCERGEN and SWOG will design and implement a ?proof-of-principle? comparative effectiveness evaluation (cost-utility analysis) in conjunction with a currently planned randomized clinical trial of gene expression profiling to guide adjuvant chemotherapy decisions among women with early-stage breast cancer and positive lymph nodes. The deliverables for this aim include a decision analytic policy model framing this trial in the context of a larger comparative effectiveness evaluation of gene expression profiling for women with node positive breast cancer, a manuscript summarizing the model, and a study protocol to be published in a clinical trials-oriented journal.

Clarification of Codes