LinkedIn Live
Beyond the Data FDA’s White Paper on Digitally Derived Measures in Clinical Trials When does a digital measure actually become evidence?
The use of digital health technologies is increasing in clinical development — but a signal is not an endpoint. FDA’s recent cross-center white paper brings the key considerations into one place. Thirty minutes with Denise Sánchez Palomo, a former FDA regulatory counsel, and Chad Patel, with live Q&A.
At a glance
- Date
- Wednesday, September 30, 2026
- Time
- 12:00–12:30 PM ET
- Format
- LinkedIn Live
- Duration
- 30 minutes + live Q&A
- Cost
- Free
- Recording
- Sent to all registrants
Why now
Digital measures are moving rapidly from exploratory tools to capturing meaningful clinical outcomes, and FDA’s recent cross-center white paper brings the key considerations into one place. It explains what can move a digitally derived measure beyond a stream of data and toward a fit-for-purpose outcome in a clinical investigation. The paper is concise, current, and essential reading for teams already developing or using these measures. Its message is clear: the value of a digital measure does not rest on the novelty of the technology, but on whether it is fit for purpose when it comes to clinical relevance and meaning to patients, its context of use and validation.
The paper: Key Considerations for the Development and Use of Digitally Derived Measures for Clinical Investigations, published jointly by CBER, CDER, CDRH, and the Oncology Center of Excellence, August 20, 2026.
What we’ll cover, in 30 minutes
A briefing built for regulatory, clinical, HEOR, and medical-affairs teams, with time set aside for the questions attendees bring with them.
Why now
Why FDA brought its digital-measures considerations together, and why the timing matters if you’re building digital endpoints.
From digital data to meaningful evidence
The chain from what matters to patients, to what you’re trying to measure, to whether the evidence can support the intended use.
What makes a DDM fit for purpose
Meaningfulness to patients, context of use, verification, analytical and clinical validation, and usability and sources of error.
What to weigh now
Patient relevance, intended use, evidence strategy, cross-functional planning, and lifecycle — with live Q&A.
A measure isn’t fit for purpose because it’s novel — it’s fit for purpose when it’s meaningful to patients, validated, and matched to its context of use.
Who’s presenting
A former FDA regulatory counsel and a strategist who works with biopharma teams where evidence, value, and access meet.
A former FDA regulatory counsel who has worked on developing guidance inside the agency and implemented it in industry.
Works with biopharma teams at the intersection of evidence strategy, value and access, and how evidence informs healthcare decision-making.
Save your spot
Thirty minutes on FDA’s recent white paper on digitally derived measures — what makes a digital measure fit for purpose, and what to weigh before a protocol locks.
Registration is confirmed by email. If you can’t make it live, register anyway and we’ll send the recording.
- Free, on LinkedIn Live, Wednesday, September 30 at 12:00 PM ET
- 30 minutes, with live Q&A
- The recording goes to every registrant
- Bring a question — there is a field for it, and it shapes the closing discussion
