AgentSkillsCN

clinical-intelligence

深入分析临床试验,包括设计、入组、结果和竞争定位。适用于试验监测、格局分析和竞争情报时。 关键词:临床、试验、NCT、入组、阶段、结果、研究设计

SKILL.md
--- frontmatter
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

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

What's Included

SectionDescriptionData Source
Trial OverviewNCT ID, title, status, datesClinicalTrials.gov
Study DesignPhase, type, arms, endpointsClinicalTrials.gov
EnrollmentTarget, actual, rate, sitesClinicalTrials.gov
EligibilityInclusion/exclusion criteriaClinicalTrials.gov
OutcomesPrimary/secondary endpointsClinicalTrials.gov, publications
Competitive MapSimilar trials comparisonAggregated
TimelineMilestones and readoutsEstimated

Output Structure

markdown
# 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

code
/clinical NCT03704547
/clinical-intelligence NCT01234567

By Target/Drug

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

Competitive Analysis

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

Enrollment Analysis

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

Running Scripts

bash
# 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

bash
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

PitfallSolution
Too many resultsAdd phase, status, or date filters
Outdated statusTrial status changes, verify current
Missing resultsResults may be in publications only
Duplicate trialsSame study may have multiple NCTs
Terminated trialsCheck why before analysis