Modern medicine has been sculpted by the ever-expanding knowledge of biological processes in conjunction with the application of experimental design. Medical advances are no longer based on anecdotal observation but on the sophisticated application of the scientific method.
Evidence-based medicine, achieved through randomized controlled trials, has transformed patient care from palliative to therapeutic to curative. Yet as health care delivery moves toward a value-based care approach — delivering high-quality care at a low cost to all patients equitably — the traditional clinical trial model is under fire for being inefficient, costly, and not representative of disease populations being studied. That means a value-based care model cannot be generated from traditional trials alone; something new is needed.