The Scientific Foundation for personal genomics: recommendations from a National Institutes of Health-Centers for Disease Control and Prevention multidisciplinary workshop.

The increasing availability of personal genomic tests has led to discussions about the validity and utility of such tests and the balance of benefits and harms. A multidisciplinary workshop was convened by the National Institutes of Health and the Centers for Disease Control and Prevention to review the scientific foundation for using personal genomics in risk assessment and disease prevention and to develop recommendations for targeted research. The clinical validity and utility of personal genomics is a moving target with rapidly developing discoveries but little translation research to close the gap between discoveries and health impact. Workshop participants made recommendations in five domains: (1) developing and applying scientific standards for assessing personal genomic tests; (2) developing and applying a multidisciplinary research agenda, including observational studies and clinical trials to fill knowledge gaps in clinical validity and utility; (3) enhancing credible knowledge synthesis and information dissemination to clinicians and consumers; (4) linking scientific findings to evidence-based recommendations for use of personal genomics; and (5) assessing how the concept of personal utility can affect health benefits, costs, and risks by developing appropriate metrics for evaluation. To fulfill the promise of personal genomics, a rigorous multidisciplinary research agenda is needed.

Clinical Pathways: Recommendations for Putting Patients at the Center of Value-Based Care.

Two major trends that have been affecting the provision of oncology care in the United States are a shift from volume-based to value-based care and a push toward patient-centered healthcare. However, these two trends are not always completely aligned with each other. Value-based payment models, including clinical pathways, are one strategy being implemented by oncology stakeholders to help encourage the uptake of value-based oncology care. If structured with the patient in mind, they can improve quality of care for patients with cancer, decrease inappropriate care while enabling appropriate personalization of care, and constrain rising prices by demanding a stronger link between cost and value. If not structured appropriately, they can limit patient choice, impede access to innovative treatments, and encourage one-size-fits-all oncology care. Clin Cancer Res; 23(16); 4545-9. ©2017 AACR.

The Impact of Alternative Payment Models on Oncology Innovation and Patient Care.

Oncology care is in a time of major transformation. Scientific discovery is driving breakthroughs in prevention, diagnostics, and treatment, resulting in tremendous gains for patients as the number of cancer survivors continues to grow on an annual basis. At the same time, there is mounting pressure across the healthcare system to contain costs while improving the quality of cancer care. In response to this pressure, private and government payers are increasingly turning to tools such as alternative payment models (APM) and clinical pathways to improve the efficiency of care, inform coverage decisions, and support shared decision-making. As APMs, clinical pathways and other tools are utilized more broadly, it will be critical that these models support the evidence-based use of innovative biomedical advances, including personalized medicine, and deliver patient-centered, high-value care. Clin Cancer Res; 22(10); 2335-41. ©2016 AACR.