Biomarker Tests for Molecularly Targeted Therapies Key to Unlocking Precision Medicine (2016) / Chapter Skim
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2 Envisioning a Rapid Learning System for Biomarker Tests for Molecularly Targeted Therapies
2 Envisioning a Rapid Learning System for Biomarker Tests for Molecularly Targeted Therapies
Pages 47-68
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From page 47... ...
The active, broad-based participation of, and collaboration among, multiple stakeholders -- including patients, health care providers, payers, health care organizations, regulatory agencies, test developers and therapy manufacturers, professional organizations, and researchers -- is required to transform the significant potential of biomarker tests for molecularly targeted therapies into the reality of improved patient care through precision medicine. In an effort to address the interrelated regulatory, reimbursement, and clinical practice challenges, the committee calls for the development of a rapid learning system approach that supports the most effective and appropriate use of biomarker tests and their associated molecularly targeted therapies, with continuous evidence development and ongoing assessment of their value.
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From page 48... ...
of the rapid learning system envisioned by the committee. LEARNING HEALTH CARE SYSTEM The notion of a learning organization was developed by organizational strategist Peter Senge, who advanced the concept in his book The Fifth Discipline (Senge, 1990)
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. Additionally, the Leadership Consortium for Value & Science-Driven Health Care, now under the auspices of the National Academy of Medicine, continues to examine this multifaceted issue.4 The concept of a learning health care system has been articulated in various ways, including a rapid learning health care system (Abernethy et al., 2010; Etheredge, 2007, 2014; Ginsburg et al., 2011)
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From page 50... ...
. The successful development of a rapid learning system for biomarker tests for molecularly targeted therapies depends on the ability of health care organizations to collect and handle large quantities of data; this presents a particular challenge in the age of precision medicine and its complex biomarker tests and molecularly targeted therapies.
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From page 51... ...
These initiatives and other programs that generate data and foster collaboration in clinically relevant research serve as a rich base of experience from which to draw insights for the establishment of a rapid learning system for the most effective use of biomarker tests for molecularly targeted therapies. Selected initiatives are discussed below, and additional examples are found in Box 2-1.
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From page 52... ...
FDA launched the Sentinel Initia tive in 2008 in response to the Food and Drug Administration Amendment Acts of 2007,b which required FDA to create a postmarket surveillance system to assess the safety of approved medical products. The Sentinel System aims to enable FDA to actively query diverse automated health care data holders, such as electronic health record (EHR)
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. Consistent with the goals of a learning health care system, Geisinger also is involved in a 5-year study with the goal of sequencing the exomes of 250,000 patients -- for research purposes as well as to improve patient care.
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The Centers for Medicare & Medicaid Services (CMS) , for example, could support a genetics-enabled learning health care system through its Innovation Center, which could test and advance best practices in genomics-enabled cancer care, using pay-forperformance approaches to improve quality (Etheredge, 2014; IOM, 2015)
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, designed to support comparative effectiveness research and clinical trials that take place in clinical care settings. PCORNet provides funding to health system– based networks whose members include hospitals, health information exchanges, and federally qualified health centers that collect electronic health information in the process of providing clinical care.
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From page 56... ...
Together they provide care for more than 2 million children annually. With PCORI funding, PEDSnet aims to create a national pediatric distributed learning health system linked to three disease-specific networks, focused on complex congenital heart disease, childhood obesity, and pediatric inflammatory bowel disease (Forrest et al., 2014)
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Ongoing focus would be on further strengthening cooperation and collaboration and creating solid partnerships among related systems to ensure that a critical learning opportunity is not wasted. A RAPID LEARNING SYSTEM FOR BIOMARKER TESTS FOR MOLECULARLY TARGETED THERAPIES The IOM's Best Care report identifies three imperatives for achieving a continuously learning health system: managing rapidly increasing complexity; achieving greater value in health care; and capturing opportunities from technology, industry, and policy (IOM, 2013a, p.
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, the committee's vision of a rapid learning system for biomarker tests for molecularly targeted therapies encompasses three key components: supportive policy environment, supporting data infrastructure, and processes to improve patient care. An illustrative representation of such a rapid learning system is shown in Figure 2-1.
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Supportive system competencies -- A learning health care system constant • ly refines complex care operations and processes through ongoing training and skill building, systems analysis and information development, and cre ation of feedback loops for continuous learning and system improvement.
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traditional barriers between research and clinical practice to support the generation of new knowledge to improve patient management and outcomes. The rapid learning system serves as the conceptual framework for the committee's recommended approaches to addressing key clinical, regulatory and reimbursement issues facing biomarker tests for molecularly targeted therapies.
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From page 61... ...
The committee's envisioned rapid learning system represents one approach to generating evidence of clinical utility of biomarker tests for molecularly targeted therapies, and would systematically collect and analyze data on biomarker tests, molecularly targeted therapies, and patient management and outcomes. The system would support continuous learning about biomarker tests for molecularly targeted therapies by integrating data from both retrospective and prospective studies as well as incorporating "real-world" clinical data captured in EHRs, generating new evidence, and subsequently applying the knowledge gained to improve patient care.
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Innovative reimbursement policy is needed to promote and support the ongoing assessment of clinical utility of biomarker tests. A rapid learning system as envisioned by the committee would facilitate the generation of clinical utility through collection and analysis of data on biomarker tests for molecularly targeted therapies.
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Processes to Improve Patient Care The third and final element of the committee's vision of a rapid learning system involves processes to improve patient care related to the effective use of biomarker tests for molecularly targeted therapies. In considering approaches to implement the process component of the rapid learning system for biomarker tests for molecularly targeted therapies, the committee identified challenges in three key areas.
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From page 64... ...
The committee's proposed approach to these challenges represents the third component of the committee's vision of a rapid learning system for biomarker tests for molecularly targeted therapies. Implementation Challenges The committee recognizes the complexity and challenging nature of implementing such a rapid learning health system, which will require first and foremost collaboration among multiple public and private agencies, health care providers, patients, insurers, researchers, members of the health information community, health policy makers, and test and drug developers and manufacturers (IOM, 2013b)
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From page 65... ...
As noted earlier, a rapid learning system represents one approach to generating evidence of clinical utility for biomarker tests for molecularly targeted therapies. Improved data collection and tracking will enable health care providers to focus on the clinical use of the most effective biomarker tests for molecularly targeted therapies.
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2012. Comparative effectiveness research, genomics enabled personalized medicine, and rapid learning health care: A common bond.
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Pre sentation to the Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies. April 1, 2015, Washington, DC.
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Presentation to the IOM Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies. April 1, 2015, Washington, DC.
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