OnCo
ideasIdea

Payer-funded trials that omit surgery or radiotherapy in low-risk patients

Many low-risk patients get operations and radiotherapy they may not need. Health systems would fund the trials that find out who can safely skip them, and keep the savings.

Payers and public funders sponsor randomised trials of omission or de-escalation of local therapy: omitting sentinel node biopsy in older women with favourable breast cancer (as SOUND and INSEMA tested), omitting radiotherapy after breast-conserving surgery in genomically low-risk disease, active surveillance instead of surgery in low-risk thyroid and prostate cancer, and shorter or lower-dose regimens. These trials save money, reduce harm and address overdiagnosis, but have no commercial sponsor. Genomic and imaging biomarkers now allow risk-adapted selection that makes omission trials ethically and statistically feasible.

Hypothesis
A payer-funded omission programme produces at least four practice-changing results within six years, each reducing the number of procedures or radiotherapy courses in the target population by a fifth or more with non-inferior recurrence.
Rationale
SOUND, INSEMA, PRIME II and the low-risk DCIS trials have shown omission is safe in defined groups and changed guidelines; each was funded with difficulty by academic grants. Payers are the natural sponsors because the savings accrue to them directly.
What would test it
A payer trials fund launches two omission trials and pre-registers projected savings; audit realised savings and outcome non-inferiority at trial completion.
Maturity
being tested at scale
Who has to act
payer
Cost to try
Medium ($1M to $50M)
Years to first evidence
4
Bottlenecks it attacks

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