Extra exclusivity for sponsors who run treatment-duration and de-escalation trials
Companies lose money when they prove a shorter course works, so they never test it. Give them a modest reward, such as extra months of exclusivity, when they do.
Regulators grant a defined exclusivity extension (for example six months, as for paediatric studies) to sponsors who complete an adequately powered randomised trial of treatment duration, stopping rules or dose de-escalation for an approved oncology drug within a set period after approval, regardless of the result. Alternatively, such trials become a condition of full approval after accelerated approval. Most immunotherapy is given for two years or until progression with no evidence for either; a legislated carrot that outweighs revenue loss from shorter courses could fix the incentive at low public cost.
- 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.
- Wrong doses · Most drug doses were chosen as the highest a person can tolerate, which is often more than they need.
- Toxicity and quality of life are undervalued · Trials measure how long people live, not how they live. Side-effects are under-reported and under-treated.
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