Phase 2/3 clinical trial design via gsDesign / gsDesign2: sample size, GS boundaries, multiplicity
Config is the same across clients — only the file and path differ.
{
"mcpServers": {
"io-github-wei-ai-lab-clinical-trial-design": {
"args": [
"-y",
"clinical-trial-design"
],
"command": "npx"
}
}
}Are you the author?
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Phase 2/3 clinical trial design via gsDesign / gsDesign2: sample size, GS boundaries, multiplicity
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A Claude Code plugin and MCP server for end-to-end clinical trial design.
clinical-trial-design helps biostatisticians and clinical trialists design Phase 2 and Phase 3 confirmatory studies through a conversational interface, backed by validated R packages (gsDesign, gsDesign2, graphicalMCP).
v0.0.13 — pre-beta. Nine MCP tools across single-primary endpoint design (binary, continuous, time-to-event under PH and four NPH frameworks), multi-hypothesis design (co-primary, multi-population, graphical multiplicity / Maurer-Bretz), Monte-Carlo verification, and Word/PDF reporting. Reasoning-chain schema with sponsor-confidential redaction. Operational kernel solves accrual ↔ duration ↔ N, plus optional
max_n/max_durationfeasibility warnings. 288/288 R tests, 18/18 MCP smoke. Published to npm (clinical-trial-design) and the official MCP registry (io.github.wei-ai-lab/clinical-trial-design). Full change history in CHANGELOG.md; API contract in API_STABILITY.md.
clinical-trial-design has four layers:
| Layer | Role |
|---|---|
R package (r-package/ClinicalTrialDesign) | Pure R statistical computation engine. Wraps and extends established packages (gsDesign, gsDesign2, graphicalMCP, simtrial) behind a unified result schema. |
MCP server (mcp-server/) | Exposes the R functions as typed tools over the Model Context Protocol so Claude Code — or any MCP client — can call them. |
Skill (skills/clinical-trial-design/) | Domain-expert prompt. Translates a user's design brief into the right tool calls and interprets results in clinical-trial terms; includes a 9-step Phase 3 orchestration workflow with waypoints. |
Benchmark corpus (benchmarks/) | 176 curated public-trial designs across 21 family directories. Each case is human-readable Markdown plus machine-readable YAML with expected outputs and tolerances. |
Plus an eval harness under eval/ (11 reproducible scenarios × six scoring dimensions × multi-vendor Claude family) and an examples gallery under examples/ (5 published trials reproduced end-to-end).
| Family | Status |
|---|---|
| Fixed-sample binary | ✅ super / NI / equivalence |
| Fixed-sample continuous | ✅ super / NI / equivalence |
| Fixed-sample TTE — PH log-rank | ✅ super / NI |
| Fixed-sample TTE — NPH MaxCombo / RMST / milestone | ✅ superiority |
| Group-sequential binary / continuous | ✅ super / NI; futility via test.type |
| Group-sequential TTE — PH | ✅ super / NI; events via Schoenfeld + OBF inflation by default (regulatory-defensible; events_calc selector) |
| Group-sequential TTE — NPH (MaxCombo / WLR / AHR) | ✅ superiority |
| Multi-hypothesis — co-primary endpoints | ✅ fixed-sequence / alpha-split / Bonferroni |
| Multi-hypothesis — multi-population (subgroup + ITT) | ✅ nested or disjoint relations |
| Multi-hypothesis — graphical (Maurer-Bretz) | ✅ initial weights + transition matrix + Rule-3 validator |
| Adaptive (SSR, enrichment, selection) | ⏳ corpus has cases; wrappers are roadmap |
| MAMS / platform / basket / umbrella | ⏳ corpus has cases; wrappers are roadmap |
| Layer | State |
|---|---|
| R package | ✅ 288/288 testthat |
| MCP server | ✅ 9 tools over stdio, esbuild bundle, 18/18 smoke |
| Skill | ✅ 9-step Phase 3 orchestration workflow + waypoints |
| Benchmark corpus | ✅ 176 curated public-trial cases / 21 families |
| Plugin manifest | ✅ .claude-plugin/plugin.json + marketplace.json |
| npm package | ✅ clinical-trial-design@0.0.13 published 2026-04-29 |
| Official MCP registry | ✅ io.github.wei-ai-lab/clinical-trial-design |
| CI release-gate | ✅ .github/workflows/release-gate.yml (R tests + R CMD check + MCP build/smoke + scenario validation) |
| LLM benchmark harness | ✅ 11 scenarios × 6-dimension rubric (eval/) |
| Pre-beta hand-off | ✅ items tracke |