The Food and Drug Administration (FDA) is announcing the availability of a draft guidance titled "E6(R3) Good Clinical Practice: Annex 2." This document was developed with the International Council for Harmonisation (ICH) and provides guidance for conducting clinical trials with decentralized and pragmatic elements, while using real-world data. The aim is to encourage innovative trial designs and to focus on critical aspects that affect participant safety and data reliability. Comments on the draft can be submitted until February 28, 2025, before the final version is prepared.
Simple Explanation
The FDA has a new draft plan that helps make sure clinical trials, like tests for new medicines, are done safely and use real-world data, with a focus on keeping people safe and making sure the results are trustable. People can share their thoughts on this plan until February 2025 before it becomes final.