现实世界数据源识别和可行性评估的当代实践和考虑
Dony Patel1, Sonia Guleria2, Lina Titievsky3
1Global Database Studies Team, Real World Solutions IQVIA, London, UK.
Pharmacoepidemiology and drug safety
|August 30, 2024
概括
现实世界数据 (RWD) 指导在不同地区有所不同,这影响了其在监管研究中的使用. 目前的做法显示不一致,突出挑战在RWD评估和可行性,尽管广泛使用指南.
科学领域:
- 药学流行病学 药学流行病学
- 监管科学 监管科学
- 医疗健康数据分析
背景情况:
- 现实世界数据 (RWD) 源的快速增长需要对监管使用的明确指导.
- 现有的监管文件为评估RWD在药物流行病学中的适用性提供了指导.
研究的目的:
- 评估不同地区 (美国,欧盟,亚太地区) 的RWD指导的差异.
- 为了评估监管研究的RWD识别和评估当前实践的变化.
主要方法:
- 将11个RWD指导文件与14个关键评估标准进行映射.
- 对国际药物流行病学学会成员进行了关于当前RWD实践的在线调查.
- 分析了RWD识别方法和参考的指导文件.
主要成果:
- 在指导文件中观察到RWD评估标准的变化.
- 37名受访者使用RWD进行营销后承诺和背景流行病学.
- 文献和数据景观是主要的RWD识别方法;FDA,ENCePP和EMA是经常引用的指南.
- 挑战包括RWD可访问性,验证和提供者的响应能力.
结论:
- 现有的RWD指南被广泛使用,但缺乏对关键评估标准的一致反映.
- 在RWD可行性评估中持续存在的挑战需要进一步关注和潜在的指导改进.
更多相关视频
09:43Databases to Efficiently Manage Medium Sized, Low Velocity, Multidimensional Data in Tissue Engineering
Published on: November 22, 2019
6.2K
08:53Integrating Computerized Linguistic and Social Network Analyses to Capture Addiction Recovery Capital in an Online Community
Published on: May 31, 2019
5.1K
相关概念视频
Data Collection I
6.1K
Data collection gathers information needed to make accurate judgments about a patient's present condition. During a health history interview, subjective data is collected from the patient, their caregivers, or family members, and objective data is collected through observations and physical assessment. Patients are the primary source of subjective data. Thus information gathered from patients through interviews, observations, and physical examination is primary data. Secondary sources of...
6.1K
Data Validation
5.0K
Data validation is an essential part of a comprehensive assessment. Validation is confirming or verifying and opening the door to gathering more assessment data as it clarifies vague or unclear data. The process of checking and verifying the collected information is called data validation. The primary purpose of data validation is to ensure data is as free from error, bias, and misinterpretation as possible.
Nursing assessment guides are generally based on holistic models rather than medical...
Nursing assessment guides are generally based on holistic models rather than medical...
5.0K
Archival Research
16.0K
Some researchers gain access to large amounts of data without interacting with a single research participant. Instead, they use existing records to answer various research questions. This type of research approach is known as archival research. Archival research relies on looking at past records or data sets to look for interesting patterns or relationships. For example, a researcher might access the academic records of all individuals who enrolled in college within the past ten years and...
16.0K
Data Collection by Observations
11.9K
Data collection refers to a systematic way of obtaining, observing, measuring, and analyzing accurate information. Observational studies are one of the most widely used methods of data collection. It involves collecting data by observing the behavior and physical characteristics of a sample without making any modifications to the sample.
An astronomer viewing the motion and brightness of stars in the sky and recording the data is an example of observational data collection. A botanist recording...
An astronomer viewing the motion and brightness of stars in the sky and recording the data is an example of observational data collection. A botanist recording...
11.9K
Convenience Sampling Method
8.8K
Sampling is a technique to select a portion (or subset) of the larger population and study that portion (the sample) to gain information about the population. Data are the result of sampling from a population. The sampling method ensures that samples are drawn without bias and accurately represent the population.
Convenience sampling is a non-random method of sample selection; this method selects individuals that are easily accessible and may result in biased data. For example, a marketing...
Convenience sampling is a non-random method of sample selection; this method selects individuals that are easily accessible and may result in biased data. For example, a marketing...
8.8K
Data Collection III
2.7K
The physical assessment examines the patient for objective data that defines the patient's condition, and aids in formulating the nursing care plan. The purpose of physical assessment is a health status appraisal, which includes identifying health problems, and establishing a database for nursing intervention.
The principles to begin the physical assessment include conducting a comprehensive or problem-related history in a quiet, well-lit room, emphasizing privacy and comfort for the...
The principles to begin the physical assessment include conducting a comprehensive or problem-related history in a quiet, well-lit room, emphasizing privacy and comfort for the...
2.7K
