OnCo
ideasIdea

Pragmatic trials in patients over 75 with function, not just survival, as the primary endpoint

For a frail 80-year-old, staying independent may matter more than living a few months longer. Trials designed for older patients should measure what they care about.

Standard oncology endpoints do not capture what matters most to many older patients: independence, cognition, and time at home. Pragmatic, embedded trials in routine care for patients over 75 with composite endpoints (survival free of functional decline, days alive and out of hospital) would produce decision-relevant evidence for the largest group of cancer patients. Cooperative groups have run a few such trials; a dedicated funding stream would create a portfolio.

Hypothesis
Pragmatic function-endpoint trials will change treatment recommendations for at least three common indications in older patients within five years, and will enrol faster per site than conventional trials.
Rationale
Older patients accept enrolment when the questions and endpoints are relevant to them; embedding in routine care reduces the burden that excludes them.
What would test it
Fund a portfolio of five pragmatic trials in the over-75s across common cancers with pre-specified composite functional endpoints and monitor accrual and guideline impact.
Maturity
early clinical
Who has to act
research
Cost to try
Large (over $50M)
Years to first evidence
5
Bottlenecks it attacks

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