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分类: 内容与媒体无需 API Key

clinical-intelligence

对临床试验的深入分析,包括设计、招募、结果和竞争定位。用于试验监控、领域分析和竞争情报。关键词:临床、试验、NCT、招募、阶段、结果、研究设计

person作者: jakexiaohubgithub

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 |