Recentrly published ICH E6 (R3) Annex 2 draft, now released for public consultation!
For the purposes of Annex 2, decentralised elements in a clinical trial are those trial-related activities conducted outside the investigator’s location (e.g., trial visit is conducted in the trial participant’s home, local healthcare centre or mobile medical units or when data acquisition is performed remotely using digital health technologies (DHTs)). Pragmatic elements in clinical trials are those that integrate aspects of clinical practice into the design and conduct of the trial (e.g., simplified protocols with streamlined data collection). Data may be broadly classified into two types, and a trial may make use of both types of data (i.e., data generated specifically for the trial (primary data collection) or data obtained from sources external to the trial that are collected for other purposes (secondary data use)). RWD incorporated in clinical trials include the use of data relating to patient health status collected from a variety of sources outside of clinical trials (e.g., electronic health records (EHRs), registries, claims data)