ideasIdea
Wearable activity data as a validated real-world endpoint
Step counts and sleep from a wristband could show whether a cancer treatment is helping or harming daily life. Prove they track survival and quality of life, then use them in real-world studies.
Performance status is coarse and clinician-rated. Wearable-derived measures (daily steps, active minutes, sleep) have correlated with survival and hospitalisation in small oncology studies. The proposal is a large validation programme: wearables issued in routine care at several centres, linked to ePRO and registry outcomes, to establish which digital measures are prognostic, responsive to treatment effect and acceptable as regulatory endpoints in real-world and pragmatic studies.
Hypothesis
A validated digital activity endpoint will predict overall survival better than clinician-rated performance status and detect treatment-related functional decline weeks earlier.
Rationale
Gresham et al. and others found step counts predict hospitalisation and survival in advanced cancer; the endpoint lacks the scale of validation regulators require.
What would test it
Issue wearables to 3,000 patients starting systemic therapy across five centres; pre-register the analysis of steps versus survival and ePRO; seek qualification of the endpoint with regulators.
Maturity
early clinical
Who has to act
research
Cost to try
Medium ($1M to $50M)
Years to first evidence
3
Bottlenecks it attacks
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
- Toxicity and quality of life are undervalued · Trials measure how long people live, not how they live. Side-effects are under-reported and under-treated.