Quality Generation and Ethical Use of Digital Health Data in Clinical Studies (QDatE)

Overview

Realizing patient-centric value from ‘digital’ is a universal problem across all aspects of life sciences. Clinical trials is a resource-intensive area of R&D and in order to support digital transformation that will benefit patients, the industry needs to work together to ensure the patient experience is interoperable and seamless for apps and digitally-enabled devices. The Pistoia Alliance established a project bringing together the industry to define quality in study design and reporting for digital medicine by establishing consistency in the evidentiary base used to support clinical applications of digital medicine tools.

This resulted in the production of Quality Data Generation and Ethical Use (QDatE) Best Practice Guidelines.