Monitoring Overall Survival in Pivotal Trials in Indolent Cancers
Overview
These guidelines are meant to provide a pragmatic, yet rigorous, help to drug developers and decision makers, since they are shaped by three fundamental ingredients: the clinically determined margin of detriment on OS that is unacceptably high (delta null); the benefit on OS that is plausible given the mechanism of action of the novel intervention (delta alt); and the quantity of information (i.e. survival events) it is feasible to accrue given the clinical and drug development setting. The proposed guidelines facilitate transparent discussions between stakeholders focusing on the risks of erroneous decisions and what might be an acceptable trade-off between power and the false positive error rate.
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- OK13 OK2026-08-05
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- OK14 OK2026-03-10
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- 75%
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- 56
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- RR 4.6.0 released · 2026-04-24
- 0.1.6Latest2025-07-17 · current release · diff ↗ ·
added 4 exports
calc_posterior, calc_predictive, find_pos, meeting_probs - RR 4.5.0 released · 2025-04-11
- RR 4.4.0 released · 2024-04-24
- 0.1.52024-03-21 · diff ↗
- 0.1.42024-03-05 · diff ↗
- 0.1.32023-10-31
- RR 4.3.0 released · 2023-04-21
Package metadata
- First published
- 2023-10-31
- Total releases
- 4 / 3 yrs
- License
- MIT + file LICENSE OSI · relicensed from GPL (>= 3) in 0.1.6
- Download size
- 138 KB
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