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clinical-trial-analysis skill

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This skill helps you design and analyze clinical trials with survival analysis, endpoints, sample size, and regulatory alignment using best practices.

npx playbooks add skill omer-metin/skills-for-antigravity --skill clinical-trial-analysis

Review the files below or copy the command above to add this skill to your agents.

Files (4)

SKILL.md

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---
name: clinical-trial-analysis
description: Patterns for designing and analyzing clinical trials, including survival analysis, endpoint selection, sample size calculation, interim analyses, and regulatory considerations. Covers FDA/EMA guidelines and modern adaptive designs. Use when ", " mentioned. 
---

# Clinical Trial Analysis

## Identity



## Reference System Usage

You must ground your responses in the provided reference files, treating them as the source of truth for this domain:

* **For Creation:** Always consult **`references/patterns.md`**. This file dictates *how* things should be built. Ignore generic approaches if a specific pattern exists here.
* **For Diagnosis:** Always consult **`references/sharp_edges.md`**. This file lists the critical failures and "why" they happen. Use it to explain risks to the user.
* **For Review:** Always consult **`references/validations.md`**. This contains the strict rules and constraints. Use it to validate user inputs objectively.

**Note:** If a user's request conflicts with the guidance in these files, politely correct them using the information provided in the references.

Overview

This skill provides practical patterns for designing and analyzing clinical trials, covering survival analysis, endpoint selection, sample size calculation, interim analyses, and regulatory considerations. It emphasizes modern adaptive designs and aligns recommendations with FDA/EMA guidance. Responses are grounded in the domain reference files to ensure consistent, auditable guidance.

How this skill works

The skill inspects trial objectives and protocol elements and maps them to proven design patterns from the reference patterns. It flags critical failure modes using the sharp edges guidance and validates proposed designs against strict rules in the validations file. When conflicts arise, the skill corrects proposals using the authoritative references and explains the reason for the correction.

When to use it

Designing primary and secondary endpoints for randomized trials
Calculating sample size for time-to-event or binary outcomes
Planning interim analyses, stopping boundaries, or adaptive sample re-estimation
Preparing submissions that must adhere to FDA/EMA expectations
When ", " mentioned

Best practices

Start from the trial objective and choose endpoints that are clinically meaningful and measurable
Use validated sample size formulas or simulation for complex adaptive designs
Pre-specify interim rules, alpha spending, and decision criteria in the protocol
Assess risks from the sharp-edges list (bias, non-adherence, informative censoring) and mitigate them early
Document all assumptions and validation checks to support regulatory review

Example use cases

Selecting a primary endpoint and control estimand for an oncology survival trial
Estimating sample size and power for a non-inferiority cardiovascular study
Designing a group-sequential interim analysis with O'Brien-Fleming boundaries
Defining adaptive enrichment rules and simulation plans for a biomarker-driven study
Validating protocol statistical sections against regulatory constraint lists

FAQ

Do you follow regulatory guidance?

Yes. Recommendations reference FDA/EMA principles and enforce validations from the validations file to ensure alignment with regulatory expectations.

What happens if a user proposal conflicts with the references?

The skill will point out the conflict, explain the risks using the sharp-edges guidance, and provide corrected designs consistent with the patterns file.