艾昆纬-人工智能领域有前景的新发展-利用生成性和代理性人工智能进行创新_以提高临床试验的效率和质量（英）-2025_12页_2mb

报告摘要

QOVIA White Paper Summary: Promising New Developments in Artificial Intelligence for Clinical Trials

Abstract

The clinical trial landscape has been transformed by the successful integration of Generative AI (GenAI) and Agentic AI into research processes. This whitepaper explores how these technologies enhance efficiency and quality while ensuring safety and compliance in clinical trials.

Key Concepts

AI Classification

Generative AI: Produces content/output based on processed data
Agentic AI: Handles complex, multi-step problems independently
Self-awareness: Recognizing limitations to provide accurate responses

Critical Safeguards

Five key categories optimize AI use in clinical trials:
1. Curating and containerizing data
2. Human-in-the-loop oversight
3. Harmonization of responses
4. Objectivity and context-awareness
5. Recognizing knowledge gaps and uncertainty

Success Use Cases

Scientific Q&A Chatbot:

Accelerated protocol query resolution
Improved decision-making while maintaining compliance
Successfully used in Phase III trials with high user satisfaction

Agentic AI for Data Review:

Comprehensive safety risk analysis
Identifies patterns invisible to human reviewers alone
Detects inconsistencies in adverse event grading

Agentic AI Monitoring Platform:

Integrates 400+ risk metrics and KPIs
Provides harmonized, accurate reporting
Enhances process efficiency and user experience
Reproducible scientific analysis

Implementation Principles

Human oversight reserved for critical decisions while automating routine processes
Technology developed with pediatric intelligence analogy ("proper training")
Inner-loop integration maintains safety standards