设计现实世界研究的战术考虑:适合目的的设计,将研究与实践联系起来
Nancy A Dreyer1, Christina D Mack2
1Dreyer Strategies LLC, Newton, MA, USA.
Pragmatic and observational research
|October 3, 2023
概括
从真实世界数据 (RWD) 获得的真实世界证据 (RWE) 提供了对不同患者群体和日常护理的见解. RWE补充了传统的试验,为临床实践和决策提供了信息.
科学领域:
- 临床研究 临床研究
- 医疗信息学 医疗信息学
- 基于证据的医学基于证据的医学.
背景情况:
- 现实世界证据 (RWE) 越来越多地被利用,这些证据是从常规临床实践中生成的现实世界数据 (RWD) 中得出的.
- RWD包括电子健康记录,患者报告的结果和来自生物传感器的数据,反映了经常被传统试验排除在外的不同患者群体.
- 这种方法旨在在现实环境中提供有关疾病影响,治疗坚持和干预有效性的见解.
研究的目的:
- 描述从RWD生成RWE的方法.
- 为临床医生提供关于设计和执行RWE研究的指导.
- 突出数据质量,透明度和偏差缓解在RWE产生的考虑因素.
主要方法:
- 讨论机会主义的研究设计和务实的临床试验.
- 强调研究参与者的代表性和数据来源.
- 通过记录链接和随机化加强RWE研究的策略.
主要成果:
- RWE研究在现实使用条件下评估医疗干预,服务和诊断,包括长期跟踪.
- 指导方针涉及参与者的代表性,数据透明度,质量评估和偏见缓解.
- 临床记录,患者生成的数据和RWD的整合对于强大的研究设计至关重要.
结论:
- 现实世界证据 (RWE) 对于在传统随机临床试验 (RCT) 之外为临床实践和决策提供信息至关重要.
- 未来的RWE一代将依赖于强大的研究设计,高效的数据采集,强大的数据策划以及临床医生,患者和研究人员之间的合作.
- 虽然RCT仍然是药物开发的核心,但RWE将显著影响临床,监管和支付人的决策.
更多相关视频
00:08A Cross-Disciplinary and Multi-Modal Experimental Design for Studying Near-Real-Time Authentic Examination Experiences
Published on: September 4, 2019
7.1K
13:40Combining Computer Game-Based Behavioural Experiments With High-Density EEG and Infrared Gaze Tracking
Published on: December 16, 2010
16.8K
相关概念视频
Study Design in Statistics
8.2K
A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
8.2K
Study Designs in Epidemiology
262
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...
262
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
145
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,...
145
Naturalistic Observations
15.5K
If you want to understand how behavior occurs, one of the best ways to gain information is to simply observe the behavior in its natural context. However, people might change their behavior in unexpected ways if they know they are being observed. How do researchers obtain accurate information when people tend to hide their natural behavior? As an example, imagine that your professor asks everyone in your class to raise their hand if they always wash their hands after using the restroom. Chances...
15.5K
Group Design
9.0K
The most basic experimental design involves two groups: the experimental group and the control group. The two groups are designed to be the same except for one difference— experimental manipulation. The experimental group gets the experimental manipulation—that is, the treatment or variable being tested—and the control group does not. Since experimental manipulation is the only difference between the experimental and control groups, we can be sure that any differences between...
9.0K
Experimental Designs
11.5K
An experimental design is a systematic process that allows researchers to evaluate the relationship between dependent and independent variables. There are three widely used types of experimental design - pre-experimental design, true experimental design, and quasi-experimental design. In pre-experimental design, the researcher compares the data before and after some interventions or treatments. The true-experimental design has more than one purposefully created group, a commonly measured...
11.5K
