As clinical data demands creep up for device-makers, industry, regulators and researchers are exploring strategies to lessen the burden. One such effort, led by the public-private Medical Device Innovation Consortium in collaboration with Duke University, is the development of a “virtual patient” study design that could allow study sponsors to rely on existing clinical trial data to potentially shrink the data needs for future trials.
The researchers who developed this model argue it could reduce the burden on trial subjects while helping bring new products to market sooner