Patent term extension scaled to proven survival gain
A drug that adds years of life would earn extra years of market protection; one that adds a few weeks would earn none. Extensions would be lost if the promised benefit is not confirmed.
Supplementary protection or regulatory exclusivity would be granted in proportion to demonstrated overall survival or cure-rate gain over the best prior standard in a randomised trial (for example one additional year of exclusivity per six months of median overall survival gain, capped at five years, with bonuses for curative-intent settings). Approvals on surrogate endpoints receive provisional extension that is confirmed or revoked when survival data mature. Regulators already collect the necessary data; the change is to the reward, not the evidence standard.
- Incentives reward me-too drugs and marginal gains · The system pays the same for a drug that adds two months as for a cure, so companies race to copy rather than to cure.
- 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.
Pages like this
not linked directly; found by shared links- IdeaSeamless phase 2/3 with pre-registered go rules as the default for new agents
Shares Overall survival (OS), Progression-free survival (PFS), Trial design, endpoints and cost.
- IdeaProvisional prices for surrogate-endpoint approvals, reset when survival data arrive
Shares Accelerated approval, Overall survival (OS), Progression-free survival (PFS).
- IdeaCheap long-term survival follow-up by linking trial participants to registries
Shares Accelerated approval, Overall survival (OS), Trial design, endpoints and cost.
- IdeaReport time toxicity, the days spent in healthcare, as a standard outcome for older patients
Shares Overall survival (OS), Progression-free survival (PFS), Trial design, endpoints and cost.
- IdeaAn abbreviated approval path for follow-on antibodies within a validated class
Shares Shorter exclusivity for later-in-class drugs without added benefit, Incentives reward me-too drugs and marginal gains, Trial design, endpoints and cost.
- IdeaA Health Impact Fund pilot that pays for measured health gain instead of price
Shares Transferable priority vouchers for first-in-class drugs, with price conditions, Incentives reward me-too drugs and marginal gains.
- IdeaAn independent programme that validates surrogate endpoints, setting by setting
Shares Accelerated approval, Overall survival (OS), Progression-free survival (PFS), Trial design, endpoints and cost.
- IdeaTime to treatment failure and quality of life as co-primary endpoints in non-curative trials
Shares Overall survival (OS), Progression-free survival (PFS), Trial design, endpoints and cost.