The VA Point-of-Care Precision Oncology Program: Balancing Access with Rapid Learning in Molecular Cancer Medicine

Abstract

The Department of Veterans Affairs (VA) recognized the need to balance patient-centered care with responsible creation of generalizable knowledge on the effectiveness of molecular medicine tools. Embracing the principles of the rapid learning health-care system, a new clinical program called the Precision Oncology Program (POP) was created in New England. The POP integrates generalized knowledge about molecular medicine in cancer with a database of observations from previously treated veterans. The program assures access to modern genomic oncology practice in the veterans affairs (VA), removes disparities of access across the VA network of clinical centers, disseminates the products of learning that are generalizable to non-VA settings, and systematically presents opportunities for patients to participate in clinical trials of targeted therapeutics.

Clinical applicability and cost of a 46-gene panel for genomic analysis of solid tumours: Retrospective validation and prospective audit in the UK National Health Service

“…Healthcare systems are now recognising the need to understand how to efficiently use genomic technologies in the context of precision medicine and verify their safety and effectiveness with timely evidence [ 9 ]. However, there is limited empirical evidence on whether results obtained from NGS technology direct clinical management and/or improve patient outcomes and whether they represent an efficient use of healthcare resources or are just an expensive addition to cancer care.…”

Socioeconomic disparities, financial toxicity, and opportunities for enhanced system efficiencies for patients with cancer

“…Frequently termed “rapid‐learning healthcare,” billions of dollars are now being invested to efficiently and reliably promote research findings for direct patient care. One example, from the VA, is the Precision Oncology Program in New England . By applying new molecular findings in cancer research to a pre‐existing repository of patient and tumor‐specific variables, veterans are given the opportunity to participate in modern genomic oncology.…”

“…One example, from the VA, is the Precision Oncology Program in New England. 66 By applying new molecular findings in cancer research to a pre-existing repository of patient and tumor-specific variables, veterans are given the opportunity to participate in modern genomic oncology. This wellthought out, funded programmatic endeavor is a model that could be replicated, given the vastness and complexity of discovery at a time of increasing economic disparity.…”

Data Sharing, Clinical Trials, and Biomarkers in Precision Oncology: Challenges, Opportunities, and Programs at the Department of Veterans Affairs

“…Problematically, the introduction of randomization (to biomarkers) into clinical care using traditional clinical trial methods is cost‐prohibitive. The Department of Veterans Affairs continues to make progress in this area through the Point‐of‐Care research9 and Precision Oncology10 Programs whereby patients are randomized to minimal risk alternatives with relaxed regulatory requirements appropriate with the degree of risk (risk‐based monitoring). Data generated from these embedded studies are derived exclusively from the EHR (real‐world evidence) and require FDA acceptance if used for registration of a new companion diagnostic.…”