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@huifer/drug-discovery-skills
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SKILL.md

name clinical-intelligence
description Deep analysis of clinical trials including design, enrollment, outcomes, and competitive positioning. Use for trial monitoring, landscape analysis, and competitive intelligence. Keywords: clinical, trials, NCT, enrollment, phase, outcomes, study design
category Clinical Intelligence
tags clinical, trials, intelligence, fda, nmpa
version 1.0.0
author Drug Discovery Team
dependencies clinicaltrials-database, fda-database, ema-database

Clinical Intelligence Skill

Comprehensive clinical trial analysis for drug development and competitive intelligence.

Quick Start

/clinical NCT03704547
/clinical-intelligence EGFR inhibitors --phase 3
Analyze all trials for KRAS G12C inhibitors
Compare NSCLC trial designs across companies

What's Included

Section Description Data Source
Trial Overview NCT ID, title, status, dates ClinicalTrials.gov
Study Design Phase, type, arms, endpoints ClinicalTrials.gov
Enrollment Target, actual, rate, sites ClinicalTrials.gov
Eligibility Inclusion/exclusion criteria ClinicalTrials.gov
Outcomes Primary/secondary endpoints ClinicalTrials.gov, publications
Competitive Map Similar trials comparison Aggregated
Timeline Milestones and readouts Estimated

Output Structure

# Clinical Trial Analysis: NCT03704547

## Executive Summary
FLAURA2 study evaluating osimertinib ± chemotherapy in first-line
EGFR-mutated NSCLC. **Status**: Active, not recruiting. **Results**: Positive PFS benefit.

## Trial Overview
| Field | Value |
|-------|-------|
| NCT ID | NCT03704547 |
| Title | Osimertinib With or Without Chemotherapy in EGFR-Mutated NSCLC |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Start Date | November 2018 |
| Primary Completion | October 2022 |
| Sponsor | AstraZeneca |

## Study Design
**Type**: Randomized, double-blind, placebo-controlled

**Arms:**
| Arm | Intervention | N |
|-----|--------------|---|
| Arm A | Osimertinib + chemotherapy | 279 |
| Arm B | Osimertinib + placebo chemo | 278 |

**Primary Endpoint:** Progression-free survival (PFS)
**Key Secondary:** Overall survival (OS), ORR, DoR

## Enrollment
| Metric | Value |
|--------|-------|
| Target Enrollment | 557 |
| Actual Enrollment | 557 |
| Enrollment Rate | On target |
| Sites | 150+ centers |
| Countries | 25+ countries |

## Key Results
- **PFS HR**: 0.62 (95% CI: 0.44-0.89)
- **Median PFS**: 25.5 vs 16.7 months
- **ORR**: 82% vs 74%
- **OS**: Mature (68% events)

## Competitive Landscape
| Trial | Drug | Phase | Status | Readout |
|-------|------|-------|--------|--------|
| NCT03704547 | Osimertinib + chemo | III | Positive | 2023 ESMO |
| NCT04035486 | Lazertinib + amivantamab | III | Recruiting | 2025 |
| NCT04887080 | Furmonertinib + chemo | III | Recruiting | 2025 |

## Site Distribution
| Region | Sites | Patients |
|--------|-------|----------|
| North America | 45 | 180 |
| Europe | 60 | 210 |
| Asia Pacific | 45 | 167 |

Examples

Trial Lookup

/clinical NCT03704547
/clinical-intelligence NCT01234567

By Target/Drug

/clinical EGFR trials --phase 3
/clinical "sotorasib" studies
Analyze all KRAS G12C clinical trials

Competitive Analysis

Compare osimertinib trials vs competitors
/clinical NSCLC --company AstraZeneca
Map phase III trials in EGFR-mutated NSCLC

Enrollment Analysis

/clinical NCT03704547 --focus enrollment
Compare enrollment rates across similar trials
Analyze site distribution for KRAS trials

Running Scripts

# Fetch trial data
python scripts/fetch_trial_data.py NCT03704547 --output trial.json

# Search for trials by condition
python scripts/fetch_trial_data.py --condition "NSCLC" --phase 3 -o results.json

# Search by drug/intervention
python scripts/fetch_trial_data.py --intervention osimertinib -o osimertinib.json

# Competitive trial mapping
python scripts/fetch_trial_data.py --target EGFR --phase 2-3 --map-competition

Requirements

pip install requests pandas

Additional Resources

Best Practices

  1. Use NCT ID: Most precise way to look up trials
  2. Specify phase: Narrow down to relevant trials
  3. Check status: Trials may be terminated/suspended
  4. Verify enrollment: Actual vs target enrollment matters
  5. Cross-reference: Check publications for results

Common Pitfalls

Pitfall Solution
Too many results Add phase, status, or date filters
Outdated status Trial status changes, verify current
Missing results Results may be in publications only
Duplicate trials Same study may have multiple NCTs
Terminated trials Check why before analysis