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Jessica K. DeMartino

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Jessica K. DeMartino

Expanding research interests in molecular profiling over the past several years have led researchers in academia and pharmaceutical and biotechnology companies to significantly increase their need for access to tissue specimens collected through clinical care and clinical trials. As a result, tissue allocation has become a growing issue for many clinical and translational investigators. High-quality biospecimens are needed by all stakeholders in order to have scientifically accurate studies and results. At the center of the process are the patients, who have increasingly become active partners in the clinical research enterprise as individuals and through highly sophisticated patient advocacy organizations. All stakeholders must recognize that human specimens, including tissue, represent a valuable and unique resource that must have proper acquisition, handling, custodianship, and consent for use in accordance with best practices for biospecimen resources.

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Jessica K. DeMartino

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Jessica K. DeMartino

Variations in the quality of cancer care are well documented. A key element of quality monitoring is standardized measures of care. Quality measures may include both process measures and outcome measures. Process measurement is only one aspect of assessing the quality of cancer care; measuring outcomes and providing the appropriate structure for care are also important. A variety of stakeholders, including professional oncology organizations and public and private payors, have developed programs and quality measures to address variations in the delivery of cancer care. To fulfill the current need to explore and discuss how quality is measured in oncology care, NCCN convened the NCCN Oncology Policy Summit: Measuring Quality in Oncology - Challenges and Opportunities. The summit was a forum to discuss current efforts to use quality measures, the value of quality measures, and patient and caretaker perspectives on quality.

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Jessica K. DeMartino

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Jessica K. DeMartino and Jonathan K. Larsen

Rising health care costs and continued concerns about safety, efficacy, and quality have resulted in the demand for more data and evidence by payors, regulators, providers, and patients alike. Stakeholders with different objectives for the use of data are driving the need for more and “better” data. It is important for organizations to not only understand how to handle and collect data but also translate it into actionable information that can help transform health care delivery. Appropriate use of data can lead to reduced health care costs and increased value to all stakeholders. In June 2012, NCCN assembled a work group composed of thought leaders from NCCN Member Institutions and other organizations to identify and examine the challenges of data generation, collection, and application for clinical, regulatory, and coverage decision-making. The NCCN Data Needs Work Group identified 4 main areas for consideration: data sources, patient-derived data, payor-collected data, and regulatory policy toward data generation and use.

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Jessica K. DeMartino and Jonathan K. Larsen

The quality of patient care varies based on numerous factors, such as health care setting, geographic location, access to medications, insurance coverage, and treatment protocols. Recently, the issue of whether use of clinical pathways can reduce costs and inappropriate variability in care has been the subject of much debate. As clinical treatment guidelines and pathways are increasingly deployed in oncology practice, they have a growing impact on the quality of treatment and how it is delivered. To fulfill the current need to discuss the use of pathways and clinical treatment guidelines in oncology and to address how patient care is impacted by their use, the National Comprehensive Cancer Network convened the NCCN Oncology Policy Summit: Equity in Cancer Care–Pathways, Protocols, and Guidelines. The summit was a forum to discuss the use and implementation of pathways, including how much flexibility pathways should allow in care, pathways’ impact on public and private health insurance benefit design, what data is used to select pathway regimens and protocols, and ultimately what impact pathways may have on variation in care. The use and implementation of clinical treatment guidelines in practice was also explored from a variety of perspectives.

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Paul F. Engstrom, Mara G. Bloom, George Daniel Demetri, Phillip G. Febbo, William Goeckeler, Marc Ladanyi, Bryan Loy, Kate Murphy, Michael Nerenberg, Paul Papagni, Mark Robson, Robert W. Sweetman, Sean Tunis, Jessica DeMartino and Jonathan K. Larsen

Personalized medicine in oncology is maturing and evolving rapidly, and the use of molecular biomarkers in clinical decision-making is growing. This raises important issues regarding the safe, effective, and efficient deployment of molecular tests to guide appropriate care, specifically regarding laboratory-developed tests and companion diagnostics. In May 2011, NCCN assembled a work group composed of thought leaders from NCCN Member Institutions and other organizations to identify challenges and provide guidance regarding molecular testing in oncology and its corresponding utility from clinical, scientific, and coverage policy standpoints. The NCCN Molecular Testing Work Group identified challenges surrounding molecular testing, including health care provider knowledge, determining clinical utility, coding and billing for molecular tests, maintaining clinical and analytic validity of molecular tests, efficient use of specimens, and building clinical evidence.

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Andrew D. Zelenetz, Islah Ahmed, Edward Louis Braud, James D. Cross, Nancy Davenport-Ennis, Barry D. Dickinson, Steven E. Goldberg, Scott Gottlieb, Philip E. Johnson, Gary H. Lyman, Richard Markus, Ursula A. Matulonis, Denise Reinke, Edward C. Li, Jessica DeMartino, Jonathan K. Larsen and James M. Hoffman

Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.