OnCo
ideasIdea

Add a cheap-drug factorial arm to every cooperative-group adjuvant cancer trial

Large adjuvant trials already follow thousands of patients for years. Adding a second randomisation to a cheap old drug would answer repurposing questions almost for free.

Factorial designs randomise the same patients to two independent questions, sharing recruitment, follow-up and infrastructure. Add-Aspirin ran as a standalone trial; embedding similar questions as second factors in cooperative-group adjuvant trials (breast, colorectal, lung, prostate) would multiply the number of repurposing questions answered at a small marginal cost. The proposal is a policy by public trial funders (NCI cooperative groups, CRUK, EORTC) that every new large adjuvant trial include, where feasible, a factorial randomisation to a prioritised off-patent candidate, with a central committee selecting candidates and monitoring interactions.

Hypothesis
Factorial add-ons answer at least one repurposing question per two adjuvant trials at less than 10% additional cost per trial, without compromising the primary question's power or recruitment.
Rationale
The main cost of an adjuvant trial is following patients for years; a second factor uses that investment twice. Interaction between factors is a manageable statistical risk when candidates are chosen for independent mechanisms.
What would test it
Embed factorial arms in the next three cooperative-group adjuvant trials and report recruitment, cost increment and analysability against the groups' previous trials.
Maturity
early clinical
Who has to act
research
Cost to try
Medium ($1M to $50M)
Years to first evidence
6
Bottlenecks it attacks

Connected

5top