| 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
- Use NCT ID: Most precise way to look up trials
- Specify phase: Narrow down to relevant trials
- Check status: Trials may be terminated/suspended
- Verify enrollment: Actual vs target enrollment matters
- 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 |