Clinical
Skill BioTender-max/awesome-bio-agent-skills/skills/labclaw/clinical
A curated collection of AI agent skills for biomedical research, covering genomics, proteomics, single-cell analysis, clinical AI, and protein design.
npx -y skills add BioTender-max/awesome-bio-agent-skills --skill clinicalAssembled from the repository path, not quoted from the project. Check it against their README if it does not work.
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SKILL.md
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Clinical Research
Overview
Clinical study design, statistical analysis, and regulatory compliance for medical research.
Study Designs
| Design | Level of Evidence | Best For |
|---|---|---|
| RCT | I | Treatment efficacy |
| Cohort (prospective) | II | Risk factors, prognosis |
| Cohort (retrospective) | III | Exposure-outcome associations |
| Case-control | III | Rare diseases, risk factors |
| Cross-sectional | IV | Prevalence, correlations |
| Case report/series | V | Novel observations |
Common Analyses
- Survival analysis: Kaplan-Meier curves, Log-rank test, Cox regression
- Diagnostic accuracy: Sensitivity, specificity, ROC curve, AUC
- Meta-analysis: Fixed/random effects, forest plot, heterogeneity (I-squared)
- Propensity score matching: For observational study confounding
- Nomogram: Predictive model visualization for clinical use
Sample Size Calculation
- Define: alpha (usually 0.05), power (usually 0.80), effect size, outcome type
- Tools: G*Power, R
pwrpackage, Pythonstatsmodels - Report: formula used, assumptions, expected dropout rate
Regulatory Compliance
- IRB/Ethics committee: Required for all human subjects research
- Informed consent: Written, voluntary, comprehensive
- ClinicalTrials.gov: Registration before enrollment (ICMJE requirement)
- GDPR/HIPAA: Data privacy for patient information
- GCP (Good Clinical Practice): ICH E6 guidelines
Reporting Guidelines
| Guideline | Study Type |
|---|---|
| CONSORT | Randomized controlled trials |
| STROBE | Observational studies |
| PRISMA | Systematic reviews / meta-analyses |
| STARD | Diagnostic accuracy |
| TRIPOD | Prediction models |
| SPIRIT | Study protocols |