Late last year, DEEP's Jacqueline Thong (GM US) sat down with Carrie Northcott (Pfizer, Head of Digital Medicine and Translational Imaging) and Jared Worful (Bayer, Global Head of Digital Health Technology and Real World Science) for a panel discussion on one of the industry's most persistent challenges: what do we do with all the evidence that's been generated for digital measures across public-private partnerships - and how do we make it usable for regulators?
That conversation has now been published as a feature article in Applied Clinical Trials.
The problem they tackled
Initiatives like Mobilise-D, IDEA-FAST, PROactive, RADAR-AD, C-Path, and DiMe have produced a wealth of validation evidence for digital endpoints. But that evidence is scattered across organizations, legacy projects, and academic institutions. When a new program needs to justify a digital endpoint to a regulator, teams often start from scratch - not because the evidence doesn't exist, but because nobody has pulled it together.
What the article covers
The article introduces the Foundational Content Consolidation initiative - a structured ''reduce, reuse, and recycle” approach for turning fragmented content into regulatory-ready evidence. More than just discussing the framework, the piece gives a practical real-world view to addressing the challenges of leveraging existing evidence, aligning terminology, and fostering collaboration both within organizations as well as across the industry.
Read the full article
The article is freely available online. We'd recommend it for anyone working on digital endpoints, regulatory strategy, or evidence generation for novel measures.
Read the full article in Applied Clinical Trials Online
Working on digital endpoints and facing the evidence consolidation challenge? Contact us we'd welcome the conversation.
