Implementation of a Precision Oncology Program as an Exemplar of a Learning Health Care System in the VA
The program determines and disseminates precision oncology best practices; enhances patient and provider engagement; and fosters collaboration among the VA, National Cancer Institute, academia, other health care systems, and industry to provide cancer patients with access to clinical trial participation.
The POP attempts to overcome these limitations by embracing the principles of a LHS with clinical trials embedded to the extent possible in the clinical care ecosystem. The creation of a precision oncology data repository derived largely from the VA Corporate Data Warehouse makes correlated data available. This repository contains patient demographics and comorbidities, tumor features and mutation status, treatments, and outcomes. Data in the repository are used to both inform individual patient care (ie, what can we learn from past patients that would inform the care of the present patient?) and to allow for generalizable discovery and validation (ie, traditional data-mining research). Given a sufficiently large POP population, clinical trial-matching algorithms will identify patients available for any number of studies open for enrollment, thus reducing the existing bottleneck in clinical trial participation.
Rationale for a National Program
Numerous organizations, including the National Comprehensive Cancer Network, the American Society of Clinical Oncology Institute for Quality, and the Society for Gynecologic Oncology, already propose tumor sequencing as the standard of care for a variety of malignancies, and there is much to suggest that additional recommendations will be forthcoming.4-6 Expanding the VISN 1 POP across the nation provides a mechanism to minimize disparities in the delivery of precision oncology across the VA. The POP will afford opportunities to create VA-centric expertise derived from the POP data repository and filtered through a national tumor board. The POP will also expand opportunities for patients to participate in clinical trials and receive state-of-the-art treatments beyond what can be offered regionally.
Both knowledge generation and the creation of a large-scale clinical trial operation require the numbers of patients that only a national POP can achieve. The economies of scale introduced by wide participation will also reduce the cost of tumor sequencing, therapeutics, and infrastructure development and will eliminate otherwise duplicate efforts that would be required to create a number of smaller regional activities. Importantly, a national POP with sufficient voice would be far more effective at moving forward the LHS agenda.
Research Activities
For the majority of POP participants, the best hope for improved quality and quantity of life lies with targeted therapeutics that are under development and available only through research protocols. The VISN 1 Clinical Trial Network (directed by Mary Brophy, MD) has developed an Oncology Consortium that includes facilities both within and outside of VISN 1. The consortium has partnered with the National Cancer Institute through a storefront mechanism with the Southwest Oncology Group to become the first national VA cancer consortium to participate in intergroup protocols. Novel therapeutics will be available to POP participants through this and other partnerships with a variety of industry sponsors.
Novel, efficient, and nationally scalable mechanisms have been proposed to facilitate clinician participation and patient enrollment in clinical trials. Additionally, MAVERIC is working with the VA Central Institutional Review Board to advance a distributed enrollment innovation, which brings the clinical trial to the patient rather than have patients travel to facilities where studies are open.
Conclusion
Unique features of the VHA enable a national rollout of the POP, which VISN 1 successfully piloted. The first of its kind effort for precision medicine within the VA holds the promise of delivering cutting-edge, life-enhancing therapy to cancer patients.
This interdisciplinary program incorporates LHS principles so that delivery of care is accompanied by analytics that can be applied to decision making for future patients. Participation in clinical trials, facilitated by the consortium model, is a cardinal feature of the POP. Opportunity exists to explore novel trial designs that meet the unique challenges presented in precision medicine, where therapeutics tailored to uncommon mutations limit patient availability.
Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
