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No company will pay to find out whether six months of its drug works as well as twelve. A dedicated public fund would pay for those trials, which save patients side effects and health systems money.
A ring-fenced fund (national research agency or philanthropic) that only supports randomised non-inferiority trials of shorter duration, lower dose, fewer cycles, omitted components or less frequent dosing of approved therapies, with a standing statistical and design core and pre-agreed non-inferiority margins co-developed with patients. Precedents: PERSEPHONE (6 vs 12 months trastuzumab), SOLD, and low-dose abiraterone; funders such as the UK NIHR HTA programme and the Anticancer Fund have supported some.
Shares Incentives reward me-too drugs and marginal gains, Cancer Research UK, Trastuzumab, Trial design, endpoints and cost.
Shares Cancer Research UK, Trial design, endpoints and cost.
Shares Incentives reward me-too drugs and marginal gains, Trastuzumab, Trial design, endpoints and cost, Pembrolizumab.
Shares Incentives reward me-too drugs and marginal gains, Cancer Research UK.
Shares Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Trial design, endpoints and cost, Toxicity and quality of life are undervalued.
Shares Trastuzumab, Pembrolizumab.
Shares Trial design, endpoints and cost, Toxicity and quality of life are undervalued.