Califf Says Wearable Sensors Must Be Part of Restructuring of Evidence Generation
FDA Commissioner Robert Califf laid out his priorities for “a major reformation of our national system for generating medical evidence” and wearable sensors were at the top of his list, in an article in the journal Clinical Trials.
Califf said the postmarket phase of clinical research “is disaggregated and often fails to answer essential questions that must be addressed to provide optimal clinical care and public health interventions.”
To solve these problems, he’s calling on the device and drug industries and regulators to focus on three key domains, the first of which is “improving the integration of and access to high-quality data from traditional clinical trials, electronic health records, and personal devices and wearable sensors.”
His other two priorities involve restructuring clinical research to support and incentivize the involvement of patients and frontline clinicians and articulating ethical constructs that enable responsible data sharing to support improved implementation.