Mapping the landscape of clinical trial regulation
The COVID-19 pandemic pushed decentralised clinical trials (DCTs) into the mainstream. But when it comes to guidance and regulations about how those trials should be performed, they’ve mostly been governed by short-term pandemic documents, many of which are set to expire.
Enter ICH E6(R3), a new draft guidance document from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This new document, designed to be resilient to changing technologies, could bring the clarity researchers are looking for. But regulators need the industry’s feedback to make that happen.
In today’s podcast, Medable chief science officer Dr Pamela Tenaerts joins host Jonah Comstock to discuss the current state of regulations in DCTs and what’s currently lacking.
She goes over some of the broad strokes of the new document and discusses what areas are ripe for input from the industry before the comment period expires in early September. She also discusses the future of clinical trials in broader terms.
You can listen to episode 94 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes, Spotify, acast, Stitcher, and Podbean.