bio-clinical-biostatistics-adaptive-designs
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 re-estimation, or master/platform-trial designs.
npx skills add BioTender-max/awesome-bio-agent-skills --skill adaptive-designs --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
## 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 **FDA 2019 Final Adaptive Designs Guidance** (Federal Register 2019-25986, Dec 2 2019) finalised the 2010 and 2018 drafts. Recognises 5 design types: group-sequential, blinded SSR, unblin
- Version Compatibility
- Regulatory Status -- The 2024-2026 Landscape
- Algorithmic Taxonomy
- Decision Tree by Scenario
- Group-Sequential Designs
- O'Brien-Fleming -- the regulatory default
- Pocock -- constant nominal
- Lan-DeMets spending function -- the modern flexibility
- Sample-size for group-sequential
- Sample-Size Re-Estimation
- Blinded SSR (Friede-Kieser 2006)
- Unblinded SSR (Cui-Hung-Wang 1999)
- Mehta-Pocock Promising Zone (2011)
- Combination Tests and CRP Principle
What does the bio-clinical-biostatistics-adaptive-designs skill do?
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 re-estimation, or master/platform-trial designs.
How do I install it?
Run `npx skills add BioTender-max/awesome-bio-agent-skills --skill adaptive-designs --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From BioTender-max/awesome-bio-agent-skills, a repository with 135 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.