Regulators accept shrinking of precancer as the endpoint for prevention drug approval
Few companies develop cancer prevention drugs because trials take decades. If regulators accepted validated precancer endpoints, as they do cholesterol for heart disease, industry would return.
Precursor regression (CIN2+, colorectal adenoma, Barrett's dysplasia, oral leukoplakia) has established links to cancer risk. Propose a regulatory framework accepting defined precursor endpoints for conditional approval, with mandated long-term cancer incidence follow-up.
- Prevention we already have is not deployed · Around four in ten cancers are preventable with tools we already own: vaccines, tobacco control, weight, alcohol, sun and infection control.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
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not linked directly; found by shared links- IdeaMake sponsors justify every trial exclusion of older and multimorbid patients
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- InstitutionMUSC Hollings Cancer Center
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- Key paperPREDIMED: a Mediterranean diet with extra-virgin olive oil and fewer breast cancers
Shares Prevention we already have is not deployed, Trial design, endpoints and cost.