The POP is highly interdisciplinary: design and implementation required buy-in and coordinated efforts from the clinical medicine, laboratory medicine, pathology, pharmacy, radiology, and research services as well as from contracting, human resources, information technology, and procurement. With more than 150 specimens processed, procedures for tissue selection, processing, shipment, and tracking have been refined, and the informatics challenges met.
A Learning Health Care System Approach
Although the standard of care in oncology is evolving to include sequencing for all solid tumors and hematologic malignancies, the lack of correlated mutation status, patient outcomes data available for analysis, and difficulties in identifying subjects eligible for clinical trials of novel therapeutics combine to slow progress. The former problem arises from the effort required to aggregate EHR data from disparate systems as well as technical and cultural barriers to data sharing. The latter problem stems from the relative rarity of patients (and the difficulty identifying them) with a given mutation that determines eligibility for a clinical trial of a particular targeted therapy.
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.
