How do I install the Clinical Trial skill?

Run npx skillmds@latest add beita6969/clinical-trial in your terminal (requires Node.js), paste this page's agent-chat prompt into Claude, Cursor, or any MCP-connected agent, or download the SKILL.md file and copy it into your agent's skills directory.

Is Clinical Trial safe to use?

This skill has not completed SkillMD's automated safety review yet. Capability flags: docs only. SkillMD never runs a skill's scripts for you; review the SKILL.md before installing.

Which AI agents work with Clinical Trial?

This skill is tagged as working with Claude Code, Claude.ai, OpenAI Codex. SKILL.md is an open format, so most agents that read a skills directory can load it too.

Is Clinical Trial free to use?

Yes. Installing skills from SkillMD is free, and the skill stays under its author's original license.

Who published Clinical Trial?

beita6969 (@beita6969) published this skill. Their other Agent Skills are listed on their SkillMD profile.

Clinical Trial by beita6969 — Agent Skill

Name: Clinical Trial
Rating: 4.2 (5 reviews)
Author: beita6969

Clinical Trial

Designs and analyzes clinical trials including sample size calculation, randomization schemes, endpoint selection, CONSORT reporting, and interim analysis planning; trigger when users ask about RCTs, Phase I-IV trials, or clinical study design.

beita6969 Updated Sep 9, 2026

File contents

When to Trigger

Activate this skill when the user mentions:

Clinical trial design, RCT, randomized controlled trial
Sample size calculation, power analysis for trials
CONSORT, STROBE, SPIRIT guidelines
Phase I, II, III, IV trials
Primary/secondary endpoints, composite endpoints
Interim analysis, adaptive trial design, futility
Blinding, randomization, allocation concealment
Intention-to-treat (ITT), per-protocol analysis

Step-by-Step Methodology

Define the research question - Specify PICO (Population, Intervention, Comparator, Outcome). Determine if superiority, non-inferiority, or equivalence design is appropriate.
Select trial phase and design - Choose phase (I: safety/dose, II: efficacy signal, III: confirmatory, IV: post-market). Consider parallel, crossover, factorial, or adaptive designs.
Primary endpoint selection - Define primary outcome (must be clinically meaningful). Specify measurement timing and minimal clinically important difference (MCID).
Sample size calculation - Specify alpha (typically 0.05, two-sided), power (typically 80-90%), expected effect size, and dropout rate. Use appropriate formula for the endpoint type (continuous, binary, time-to-event).
Randomization and blinding - Recommend randomization method (simple, block, stratified, minimization). Specify blinding level (open-label, single, double, triple).
Statistical analysis plan - Pre-specify primary analysis method (t-test, chi-square, log-rank, mixed models). Define interim analysis schedule with alpha-spending function (O'Brien-Fleming, Lan-DeMets).
Reporting - Follow CONSORT for RCTs, STROBE for observational, SPIRIT for protocols. Include flow diagram, enrollment numbers, and all pre-specified analyses.

Key Databases and Tools

ClinicalTrials.gov - Trial registration and results
Cochrane Library - Systematic reviews of trials
FDA / EMA guidance documents - Regulatory requirements
nQuery / PASS / G*Power - Sample size software
CONSORT / SPIRIT checklists - Reporting standards

Output Format

Sample size as a table: assumptions, formula, per-arm and total N.
Trial design as a structured summary: phase, design type, arms, blinding, duration.
CONSORT flow diagram description with all participant numbers.
Statistical analysis plan with pre-specified primary and secondary analyses.

Quality Checklist

PICO clearly defined
Primary endpoint is clinically meaningful and measurable
Sample size assumptions explicitly stated with references
Dropout rate factored into sample size
Randomization and blinding method specified
Multiple comparison adjustment for secondary endpoints
Interim analysis boundaries pre-specified if applicable
ITT and per-protocol populations defined
Regulatory guideline alignment noted (FDA/EMA/ICH)

---name: clinical-trialdescription: Designs and analyzes clinical trials including sample size calculation, randomization schemes, endpoint selection, CONSORT reporting, and interim analysis planning; trigger when users ask about RCTs, Phase I-IV trials, or clinical study design.--- ## When to Trigger Activate this skill when the user mentions: - Clinical trial design, RCT, randomized controlled trial - Sample size calculation, power analysis for trials - CONSORT, STROBE, SPIRIT guidelines - Phase I, II, III, IV trials - Primary/secondary endpoints, composite endpoints - Interim analysis, adaptive trial design, futility - Blinding, randomization, allocation concealment - Intention-to-treat (ITT), per-protocol analysis ## Step-by-Step Methodology 1. **Define the research question** - Specify PICO (Population, Intervention, Comparator, Outcome). Determine if superiority, non-inferiority, or equivalence design is appropriate. 2. **Select trial phase and design** - Choose phase (I: safety/dose, II: efficacy signal, III: confirmatory, IV: post-market). Consider parallel, crossover, factorial, or adaptive designs. 3. **Primary endpoint selection** - Define primary outcome (must be clinically meaningful). Specify measurement timing and minimal clinically important difference (MCID). 4. **Sample size calculation** - Specify alpha (typically 0.05, two-sided), power (typically 80-90%), expected effect size, and dropout rate. Use appropriate formula for the endpoint type (continuous, binary, time-to-event). 5. **Randomization and blinding** - Recommend randomization method (simple, block, stratified, minimization). Specify blinding level (open-label, single, double, triple). 6. **Statistical analysis plan** - Pre-specify primary analysis method (t-test, chi-square, log-rank, mixed models). Define interim analysis schedule with alpha-spending function (O'Brien-Fleming, Lan-DeMets). 7. **Reporting** - Follow CONSORT for RCTs, STROBE for observational, SPIRIT for protocols. Include flow diagram, enrollment numbers, and all pre-specified analyses. ## Key Databases and Tools - **ClinicalTrials.gov** - Trial registration and results - **Cochrane Library** - Systematic reviews of trials - **FDA / EMA guidance documents** - Regulatory requirements - **nQuery / PASS / G*Power** - Sample size software - **CONSORT / SPIRIT checklists** - Reporting standards ## Output Format - Sample size as a table: assumptions, formula, per-arm and total N. - Trial design as a structured summary: phase, design type, arms, blinding, duration. - CONSORT flow diagram description with all participant numbers. - Statistical analysis plan with pre-specified primary and secondary analyses. ## Quality Checklist - [ ] PICO clearly defined - [ ] Primary endpoint is clinically meaningful and measurable - [ ] Sample size assumptions explicitly stated with references - [ ] Dropout rate factored into sample size - [ ] Randomization and blinding method specified - [ ] Multiple comparison adjustment for secondary endpoints - [ ] Interim analysis boundaries pre-specified if applicable - [ ] ITT and per-protocol populations defined - [ ] Regulatory guideline alignment noted (FDA/EMA/ICH)

Frequently asked questions