bio-clinical-biostatistics-adaptive-designs SKILL.md skillA
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mdr add pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs@git:20260821.2d1b678Pins git:20260821.2d1b678 in mdr.lock. Pin the fingerprint instead.
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skills/bioskills/bio-clinical-biostatistics-adaptive-designs/SKILL.md- Versions recorded
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Designs adaptive clinical trials including group-sequential (O'Brien-Fleming, Pocock, Lan-DeMets spending), sample-size re-estimation (blinded Friede-Kieser, unblinded Cui-Hung-Wang, Mehta-Pocock promising zone), seamless Phase 2/3 with treatment-arm selection, population enrichment, and response-adaptive randomisation. Covers FDA 2019 Final Adaptive Designs Guidance, FDA 2022 Master Protocols, and ICH E20 Step 2b/3 draft (June 2025, NOT final). Use when planning interim analyses, sample-size…
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What the file says
## Version Compatibility
Reference examples tested with: R `rpact` 4.2+ (Wassmer/Brannath), `gsDesign` 3.6+ and `gsDesign2` 1.1+ (Anderson/Merck), `adaptr`, `simtrial`. Commercial: East/EastHorizon (Cytel), ADDPLAN (ICON), FACTS (Berry Consultants).
Before using code patterns, verify installed versions match. If versions differ:
- R: `packageVersion('<pkg>')` then `?function_name`
- Python adaptive packages are limited; R is the regulatory de facto standard
If code throws an error, introspect the installed package and adapt the example to match the actual API rather than retrying.
# Adaptive Clinical Trial Designs
**"Design an adaptive trial"** -> Pre-specify a design with one or more interim adaptations (early stopping, sample-size re-estimation, treatment selection, population enrichment, randomisation ratio changes) that strongly controls Type-I error at the trial-wide level via combination tests or the Conditional Rejection Probability principle.
## Regulatory Status -- The 2024-2026 Landscape
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mdr add pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs@sha256:a8614f0850d06053The line at the top of this page pins the label git:20260821.2d1b678, which is what most people want. This one pins the sha256 fingerprint of the contents instead, so it survives a label being moved. Either way the exact version is written to mdr.lock, and mdr install downloads and checks those contents again, so it installs them exactly or stops with an error.
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The registry has recorded 1 version of this file, committed on Aug 21, 2026.
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Source
pku-yuangroup/openai4s · 638 stars · license MIT · pushed 2026-10-21 · branch main
API
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