Adaptive Trial Designs for Assessing Predictiveness of a Biomarker in Early Phase Drug Development
Libby Daniells, Julia Geronimi, Hugo Hadjur, Sandrine Guilleminot, Pavel Mozgunov · 2026
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Description
Libby Daniells and co-authors design smarter early drug trials in 2026 for spotting patients a drug will truly help. A marker is predictive if it flags who gains from a treatment, not just who fares well anyway. Proving that in the small trials of early development is statistically hard, and one known test, though better than rivals, still lacks power when arms are small and uneven.
Their fix adapts as the trial runs: if an interim check hints at a marker effect, enrollment grows where it counts. Past adaptive designs mostly narrowed entry rules instead. More power in small trials matters because a missed marker can kill a drug that would have helped a clear subgroup, or send a weak drug onward.
Catalog record
| CREATOR | Libby Daniells, Julia Geronimi, Hugo Hadjur, Sandrine Guilleminot, Pavel Mozgunov |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 96 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |