To achieve broad adoption and positively impact health, digital medicine products require evidence to demonstrate that they are trustworthy. The quality and quantity of evidence required to deem a product fit-for-purpose are not agreed upon by industry, patient, or government stakeholders. Currently, there is no consensus on what constitutes “evidence” or what metrics should be used to distinguish high-quality evidence from low-quality evidence.
Defining quality in study design and reporting will drive the field of digital medicine towards maturity by establishing consistency in the evidentiary base used to support clinical applications of digital medicine tools. This will in turn allow trials to be run in a distributed fashion, collecting more critical data which will help produce better outcomes and more precision medicines.
The project will combine inputs from the key areas of digital medicine – patients, CROs, sponsors and technology companies to ensure that each stakeholders requirements are considered.