clinical-intelligence

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

• ClinicalTrials.gov API
• Trial Fields Reference
• FDA Database Links

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