The Challenge
A biotech company approached DEEP Measures about the possibility of using a digital endpoint in upcoming phase 2 and phase 3 studies. Their phase 2 was to be a small proof-of-concept study and they know that the standard endpoints may not be sensitive enough to demonstrate impact given the mechanism-of-action for their therapy. The clinical study team was keen on exploring the use of a digital endpoint but they needed to see if they could justify the investment.
The Approach
DEEP performed a high-level Return-on-Investment calculation intended to support a fast go/no-go rationale for proposing digital endpoints within the clinical program.
ROI was quantified as Expected Value Uplift ($) from adding digital measurements divided on Incremental Cost ($) of the digital measures development & implementation cost:
Definition of “ROI”: Digital measures are justified if they increase expected program value by either:
- Accelerating time-to-market / time-to-inflection (avoiding an extra study; faster Phase 2b/3 decisions; earlier partnering)
- Increasing Probability of Success (PoS) by reducing endpoint noise and strengthening mechanistic plausibility,
- Improving differentiation (especially on behavioral health, stress/arousal, caregiver burden), improving partnering economics and/or access narrative.
We calculate each as an Expected Value (EV) term, then sum them.
Assumptions
- Trials for the given indication are endpoint-noise-limited: Caregiver-reported scales remain essential, but objective corroboration is valuable in small-N, open-label settings.
- The therapy’s differentiation goes beyond an in-clinic assessment: The mechanistic story supports benefits in behavioral dysregulation, stress/arousal, sleep stability, and caregiver burden, domains where digital signals can be more sensitive and less biased.
- Even low probabilities justify the spend: Because the digital package cost is low relative to clinical program spend, a small probability of avoiding a delay or improving a key inflection point creates meaningful expected value.
- Digital measure investment: estimated at $1.5M one-off cost including endpoint definition, tech setup, analytical validation, trial deployment
Impact
Lever 1: Expected Value of Time Acceleration: $7.5M
Lever 2: Expected Value of Probability of Success: $4.5M
Lever 3: Expected Value of Differentiation: $7.5M
Total Expect Value Uplift: $19.5M
With approximately $20M expected value uplift for a $1.5M investment in using a digital endpoint, the expected ROI is 13x.
Key Learnings
- For small pharma companies and biotechs that do not have well-development digital endpoint teams, it can be daunting to consider integrating a digital endpoint into a clinical program.
- Ironically, organizations with higher pressure to meet milestone goals and timelines may in fact be better served by utilizing digital endpoints.
- A digital endpoint may not help all programs, but DEEP Measures can help organizations quickly evaluate whether a digital endpoint may add advantage to a program.
Call to Action
If you’re interested in learning how DEEP Measures can help you select and use a digital endpoint in your clinical research program, contact us.
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