Precision Oncology Program
The VA Precision Oncology Program (POP), initiated in VISN 1 and funded through a clinical care budget, goes a step further toward creating learning opportunities. The POP sequences the DNA of tumor tissue from veterans newly diagnosed with cancer to determine the DNA mutations responsible for the tumor development and behavior. Armed with this information, HCPs can optimize therapy based on mutation status by the delivery of drugs that are targeted against particular gene products.
Systematic implementation of the POP across all VAMCs will reduce disparities in cancer care induced by variation in medical center familiarity with treatment options. Features supported by the POP include enhanced enrollment of patients into clinical trials of novel targeted therapeutics and sharing of patient outcomes data to assist in decision support for future patients. In addition, this approach could facilitate the creation of a national VA database of cancer patient characteristics, tumor mutations, and cancer-related treatments and outcomes to accelerate the pace of discovery in VA cancer care.
Million Veteran Program
The Million Veteran Program (MVP) is a VA ORD initiative that asks veterans to share their medical data, lifestyle, and genetic data with researchers to allow for the discovery of correlations between their genetic profile and their health, disease and response totreatments. Currently more than 430,000 veterans have agreed to participate and have donated data and blood samples, and researchers are performing the first projects to use this resource.
Although the knowledge gained from these studies will be indirectly relevant to veterans in general the MVP presents an opportunity to present specific findings to individual participants that will directly affect their care. While reuse of the MVP resource for precision medicine is under consideration, there are important cultural and technical barriers that must be addressed. Like POP, integration of the MVP research program with clinical care should be carried out with consideration of a community of stakeholders and not driven exclusively by a research agenda.
Challenges in Moving Forward
Central to the implementation of a learning mechanism in health care systems is the recognition by administrators of the importance of the activity and appreciation of the business argument favoring the investment. This runs counter to the current notion of separate silos for health care and medical research whereby health care systems are liberated from the cost of investigation but then suffer from a dearth of knowledge relevant to their operation.
Additionally, research enterprises are not structured for such activities. Academic investigators are incentivized to create knowledge and generate publications and they understand best the currency of grant funding. Their world is not geared to reinvent or engineer solutions for health care systems. In light of these considerations, a decentralized approach that creates institutions for local learning needs to be developed and “owned” by individual and groups of medical centers with engagement of administration, patient, scientific, and community stakeholders. The Patient-Centered Outcome Research Institute (PCORI) and the consortia it has funded, PCOR-Net, have adopted this approach. 3
Importantly, a new set of ethical and regulatory standards that distinguish it from traditional research must accompany progress in the creation of a learning health care system (LHS). Sharing of patient data to benefit fellow patients must come to be expected and without the formalized sharing agreements that are required in traditional research activities. Although the digitization of medical records makes most of what this article discusses possible, execution requires access to information technology resources and a talented staff.
