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Related Concept Videos

Clinical Trials01:16

Clinical Trials

6.6K
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...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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,...
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Hazard Ratio01:12

Hazard Ratio

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The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
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Data Collection by Experiments01:13

Data Collection by Experiments

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Data collection is a systematic method of obtaining, observing, measuring, and analyzing accurate information. An experimental study is a standard method of data collection that involves the manipulation of the samples by applying some form of treatment prior to data collection. It refers to manipulating one variable to determine its changes on another variable. The sample subjected to treatment is known as “experimental units.”
An example of the experimental method is a public...
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Observational Studies01:11

Observational Studies

8.1K
Observational studies are a type of analytical study where researchers observe events without any interventions. In other words, the researcher does not influence the response variable or the experiment's outcome.
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One...
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Data Collection by Observations01:08

Data Collection by Observations

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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...
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A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
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Linkage of Clinical Trial Data to Routinely Collected Data Sources: A Scoping Review.

Mehdi NajafZadeh1, Ana Fernández Oromendia1, Mehmet Burcu2

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Linking clinical trial data with routinely collected health data enhances trial insights. Most studies obtained prospective consent or ethical waivers for data linkage, demonstrating feasibility and diverse applications.

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Area of Science:

  • Health Informatics
  • Clinical Trial Management
  • Data Science

Background:

  • Routinely collected data (RCD) from healthcare interactions offer valuable insights.
  • Linking RCD to clinical trial data can deepen understanding of treatment benefits, risks, and costs.
  • Participant-level linkage supplements active data collection in trials.

Purpose of the Study:

  • To review clinical trials linked with RCD globally.
  • To identify use cases and designs of these data linkage studies.
  • To assess the feasibility and implementation of linking clinical trial data with RCD.

Main Methods:

  • Searched PubMed and MEDLINE for studies linking clinical trials to RCD (2016-2023).
  • Included studies on medications, vaccines, devices, procedures, and diagnostics.
  • Excluded opinion pieces, protocols, and behavioral intervention studies.

Main Results:

  • 71 studies were included, with 42 focusing on medications/vaccines/supplements and 29 on devices/procedures/diagnostics.
  • Common use cases included post-trial follow-up (31%), outcome capture (26.8%), outcome validation (23.9%), and cost analysis (16.9%).
  • 45.1% obtained prospective consent, and 46.5% received ethical waivers for data linkage.

Conclusions:

  • Linking clinical trial data with RCD is feasible and implemented across various applications.
  • Prospective consent or ethical waivers are commonly used for data linkage.
  • This approach provides a comprehensive overview of linking trials to RCD, enhancing research value.