用分散元素进行临床试验的患者中心性和数据完整性的评估方法:一项对的试验
Jiyeon Park1, Ki Young Huh1, Jae-Yong Chung2
1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Clinical and translational science
|September 4, 2025
概括
在分散的临床试验中评估患者中心性和数据完整性. 这些工具有助于评估将试验活动转移到传统地点的影响,从而改善未来的试验设计.
科学领域:
- 临床试验方法
- 以患者为中心的护理
- 数据完整性
背景情况:
- 分散的临床试验通过将活动转移到场外来增强患者的中心性.
- 在分散的试验中进行远程数据收集会对数据完整性带来风险.
- 目前评估这些关键因素的方法有限.
研究的目的:
- 提出和验证在分散的试验中测量患者中心性的方法.
- 引入一个分析框架来评估分散的试验元素中的数据完整性.
- 在试点研究中探索这些方法的可行性.
主要方法:
- 通过将自我评估负担与传统方法进行比较来衡量患者中心性.
- 通过准确的性能率,错误来源和后果来评估数据完整性.
- 实验性临床试验的方法
主要成果:
- 在可穿戴药物监测方面,患者中心性最高 (4.30),在远程同意方面最低 (1.80).
- 数据完整性最低的可穿戴式监控 (88.6%),因设备问题和连接而导致的错误.
- 自动收集便的数据完整性较低 (90.0%),导致分析延迟.
结论:
- 拟议的方法为评估分散试验影响提供了基础.
- 这些工具可以帮助预测和管理与患者中心性和数据完整性相关的挑战.
- 这些方法的进一步应用可以优化分散的临床试验设计.
更多相关视频
相关概念视频
Clinical Trials
7.8K
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...
7.8K
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
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
Study Designs in Epidemiology
410
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
410
Blind Procedures
12.1K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
12.1K
Analysis of Population Pharmacokinetic Data
382
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
382


