在临床试验风险评估中对人工智能应用的范围审查
Douglas Teodoro1, Nona Naderi2, Anthony Yazdani3
1Department of Radiology and Medical Informatics, Faculty of Medicine, University of Geneva, Geneva, Switzerland. douglas.teodoro@unige.ch.
NPJ digital medicine
|July 29, 2025
概括
人工智能 (AI) 增强了临床试验安全性和效率的风险评估. 人工智能模型看起来很有前途,但需要解决数据质量等挑战,以便更广泛地采用.
科学领域:
- 临床研究 临床研究
- 人工智能的人工智能
- 风险管理 风险管理
背景情况:
- 人工智能 (AI) 越来越多地被用于临床试验风险评估,以提高安全性和运营效率.
- 越来越多的研究正在探索AI应用,用于预测临床试验中的安全性,有效性和运营风险.
研究的目的:
- 对应用人工智能的临床试验风险评估研究进行范围审查.
- 识别人工智能技术,数据源和安全,有效性和运营风险预测中的应用.
- 评估AI驱动的临床试验风险评估的性能和挑战.
主要方法:
- 在2013年至2024年间发表的142项研究的系统搜索和分析.
- 基于风险预测重点的研究分类:安全性 (55),有效性 (46) 和操作性 (45).
- 识别和合成人工智能方法 (机器学习,深度学习,LLM) 和使用的数据源.
主要成果:
- 人工智能技术,包括传统的ML,深度学习和因果ML,用于预测不良事件,治疗效应和试验阶段过渡.
- 利用多种数据来源,从分子数据和协议到患者信息和出版物.
- 大型语言模型 (LLM) 显示了最近应用的激增,在2023年33项研究中的7项中出现,报告的性能高达96%AUROC.
结论:
- 基于人工智能的风险评估显示了提高临床试验安全性和效率的巨大潜力.
- 解决诸如选择偏见,有限的前景验证和数据质量等挑战对于实现人工智能的全部影响至关重要.
- 人工智能有望改变临床试验,特别是在开发基于风险的高级监测框架方面.
相关概念视频
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
176
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
176
01:11Clinical Trials: Overview
3.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.4K
01:16Clinical Trials
8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
8.5K
01:28Preclinical Development: Overview
4.8K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.8K
01:29Issues And Trends In Healthcare Delivery System
5.8K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.8K
01:19Pharmacovigilance
996
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
996