Real-world dose intensity and toxicity monitoring to revise labelled doses
Track how much of each cancer drug patients actually receive and how often they need to reduce it, and use that to change the official dose when the label is too high.
Many oncology drugs are labelled at doses most patients cannot tolerate; dose reductions in practice are common but invisible to regulators. Project Optimus addresses dose selection before approval; nothing systematic addresses it after. The proposal uses structured prescribing data to publish real-world dose intensity, reduction rates and toxicity per drug annually, with a regulatory pathway to update labels when the real-world modal dose differs from the label.
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
- 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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