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evidence-data· 16 May 2026· 13 min read
What good evidence generation looks like at IND
Decisions you make at IND show up in your HTA dossier seven years later.
Author
Chief Innovation Officer
Three decisions that compound
Endpoint choice, comparator strategy, and biomarker / subgroup definitions made at IND show up in your HTA dossier seven years later — usually as gaps you can't close without a new trial.
| Decision | Cheap at IND | Expensive at HTA |
|---|---|---|
| Primary endpoint | Pick OS-surrogate carefully; map to HTA expectations | Surrogate the committee won't accept |
| Comparator | Trial vs realistic SoC; plan ITC explicitly | Comparator nobody in EU5 uses |
| Subgroups | Pre-specify EU5-relevant subgroups | Post-hoc subgroup the ERG dismisses |
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