ideasIdea

Factorial trials that test several cheap generics at once in the adjuvant setting

One large trial can test aspirin, a statin, metformin and exercise at the same time by randomising each separately, answering four questions for the price of one.

A 2x2x2 factorial randomises each patient to each intervention independently, so main effects of several low-cost interventions are tested with the same participants. The Add-Aspirin trial and the earlier ATAC-style factorials show feasibility. Generic repurposing candidates have no sponsor, so factorial efficiency is the only way many will ever be tested.

Hypothesis

A factorial adjuvant trial of three generics in colorectal cancer will report main effects for all three with adequate power at a per-question cost below one third of separate trials.

Rationale

Interventions with different mechanisms rarely interact strongly; factorial designs exploit this. Cooperative groups have the infrastructure.

What would test it

Design and fund a 2x2x2 factorial in stage III colon cancer (for example aspirin, a statin and vitamin D) with disease-free survival as the primary endpoint.

Maturity

early clinical

Who has to act

research

Cost to try

Large (over $50M)

Years to first evidence

Bottlenecks it attacks

Too many combinations to test · There are thousands of possible drug pairs and sequences. Trials can test a few dozen a year.
No incentive to repurpose cheap drugs · Old, cheap drugs with anti-cancer signals never get the trials they need because no one profits from the result.

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Factorial trials that test several cheap generics at once in the adjuvant setting

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