Clinical Trial
- 17 installs
- 869 repo stars
- Updated June 8, 2026
- beita6969/scienceclaw
clinical-trial is a skill that designs and analyzes clinical trials, covering sample-size calculation, randomization, endpoint selection, CONSORT reporting, and interim analysis.
About
Clinical-trial is a skill that designs and analyzes clinical trials. A developer or researcher uses it to calculate sample size and power, choose randomization and blinding schemes, select endpoints, and plan interim analyses following CONSORT, STROBE, and SPIRIT standards. It follows a 7-step methodology from PICO definition through reporting. It is triggered by questions about RCTs and Phase I-IV trial design.
- Designs RCTs with sample-size calculation, randomization, and endpoint selection
- Follows CONSORT, STROBE, and SPIRIT reporting guidelines
- Plans interim analysis with alpha-spending functions
Clinical Trial by the numbers
- 17 all-time installs (skills.sh)
- Ranked #1,286 of 2,065 Data Science & ML skills by installs in the Skillselion catalog
- Data as of Aug 2, 2026 (Skillselion catalog sync)
clinical-trial capabilities & compatibility
- Capabilities
- clinical trials search · clinicaltrials database · biostatistics
- Use cases
- research · data analysis
- Pricing
- Free
What clinical-trial says it does
Designs and analyzes clinical trials including sample size calculation, randomization schemes, endpoint selection, CONSORT reporting, and interim analysis planning
Follow CONSORT for RCTs, STROBE for observational, SPIRIT for protocols.
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| Installs | 17 |
|---|---|
| repo stars | ★ 869 |
| Last updated | June 8, 2026 |
| Repository | beita6969/scienceclaw ↗ |
What it does
Design and analyze clinical trials including sample size, endpoints, randomization, and CONSORT reporting.
Who is it for?
Designing RCTs and Phase I-IV trials with proper power analysis and reporting
When should I use this skill?
A user asks about RCTs, Phase I-IV trials, sample size, or clinical study design
What you get
- Sample-size table with assumptions and per-arm N
- Structured trial-design summary
- Statistical analysis plan
By the numbers
- 7-step methodology
- 9-item quality checklist
Files
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 / GPower** - 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)
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What reporting standards does clinical-trial follow?
CONSORT for RCTs, STROBE for observational studies, and SPIRIT for protocols.
What does the sample-size step require?
Alpha (typically 0.05 two-sided), power (typically 80-90%), expected effect size, and dropout rate.