数字生物标志物 (dBM) 作为临床试验终点的趋势:对开放数据的二次分析
Mizuki Morita1,2, Mina Honjoh2, Takahiro Yamane1
1Department of Biomedical Informatics, Faculty of Interdisciplinary Science and Engineering in Health Systems, Okayama University.
Studies in health technology and informatics
|August 8, 2025
概括
数字生物标志物 (dBM) 越来越多地被用作临床试验的终点,特别是对于内分泌和代谢条件. 建议进一步扩大疾病范围和设备种类,以最大限度地提高它们的研究效用.
科学领域:
- 生物医学研究的研究.
- 临床试验方法论 临床试验方法论
- 数字健康数字健康
背景情况:
- 数字生物标志物 (dBM) 是临床研究中的新兴工具.
- 需要为dBM在临床试验中的使用制定指南.
- 了解dBM应用的当前趋势至关重要.
研究的目的:
- 分析2005-2023年间的临床试验数据.
- 评估作为终点 (dEP) 使用的数字生物标志物的频率和类型.
- 为了确定与dEP相关的目标疾病和设备类型.
主要方法:
- 临床试验数据 (2005-2023) 的回顾性分析.
- 按器械类型和目标疾病对dBM进行分类.
- 评估dEP作为主要和次要终点.
主要成果:
- 自2020年以来,使用dEP的临床试验显著增加 (每年15-20次).
- 内分泌和代谢条件是dEP最常见的目标.
- 动图和血糖传感器是最常见的设备,具有特定的应用.
结论:
- 数字生物标志物作为临床试验的终点的使用正在增长.
- 目前的应用集中在特定的疾病领域和设备类型.
- 扩大疾病范围和设备多样性将提高dBM在临床研究中的实用性.
更多相关视频
07:40Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
17.2K
07:20Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies
Published on: January 28, 2014
36.7K
相关概念视频
Clinical Trials
8.4K
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...
8.4K
Clinical 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
Issues 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
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
174
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,...
174
