clinical-intelligence
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
When & Why to Use This Skill
The Clinical Intelligence skill is a specialized analytical tool designed for pharmaceutical professionals, researchers, and competitive intelligence analysts to perform deep-dive evaluations of clinical trials. By aggregating real-time data from ClinicalTrials.gov, FDA, and EMA, it provides comprehensive insights into study designs, enrollment metrics, and clinical outcomes. This skill streamlines the process of monitoring the drug development landscape, allowing users to track NCT IDs, compare competitive positioning, and forecast trial milestones with high precision.
Use Cases
- Competitive Intelligence: Compare efficacy data (such as PFS or ORR) and safety profiles between your drug candidate and competitors to identify market advantages.
- Landscape Analysis: Map all active Phase 2 and Phase 3 trials for specific molecular targets (e.g., EGFR, KRAS) to understand research density and identify therapeutic gaps.
- Trial Monitoring & Feasibility: Analyze enrollment rates, site distributions, and recruitment statuses to evaluate the progress and potential delays of specific clinical studies.
- Protocol Optimization: Extract and review inclusion/exclusion criteria and primary endpoints from successful trials to inform the design of new clinical protocols.
| name | clinical-intelligence |
|---|---|
| description | | |
| 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 |
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 |