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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.1K
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

319
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,...
319
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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Clinical Trials: Overview01:11

Clinical Trials: Overview

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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...
4.4K
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

751
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...
751
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

75
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Advancing Clinical Trial Efficiency and Data Accuracy through Direct EHR-to-EDC Integration.

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Related Experiment Video

Updated: Dec 17, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

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eSource-Enabled vs. Traditional Clinical Trial Data Collection Methods: A Site-Level Economic Analysis.

Eric L Eisenstein1, Maryam Y Garza2, Mitra Rocca3

  • 1Duke University, Durham, NC, United States.

Studies in Health Technology and Informatics
|June 24, 2020
PubMed
Summary

Electronic source (eSource) data extraction from electronic health records can improve clinical trial efficiency. Study characteristics like patient enrollment and data element volume significantly influence the economic viability of eSource compared to traditional methods.

Keywords:
HL7 FHIRclinical trialdata collectioneSourceeconomic analysis

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Area of Science:

  • Clinical research informatics
  • Health data management
  • Clinical trial operations

Background:

  • Traditional clinical trial data collection is time-consuming and prone to errors.
  • Electronic source (eSource) data aims to streamline data capture directly from electronic health records (EHRs).
  • Understanding the economic factors influencing eSource adoption is crucial for optimizing clinical trial processes.

Purpose of the Study:

  • To identify key clinical trial characteristics that affect the economic attractiveness of eSource data capture.
  • To compare the economic feasibility of eSource versus traditional data collection methods across different trial scenarios.

Main Methods:

  • The study analyzed factors influencing the economic viability of eSource.
  • Key variables included patient enrollment numbers, data element quantity, and data collection time.
  • The percentage of data extractable via eSource software was also assessed.

Main Results:

  • Site patient enrollment numbers directly impact eSource economic attractiveness.
  • The volume of study data elements and coordinator data collection times are significant factors.
  • The proportion of data extractable via eSource software influences its cost-effectiveness.
  • The impact of these factors varies depending on the specific clinical trial design.

Conclusions:

  • The economic benefits of eSource are contingent upon specific clinical trial attributes.
  • Factors such as patient volume and data complexity must be considered when evaluating eSource implementation.
  • Optimizing eSource adoption requires a nuanced understanding of its interplay with trial design and site-specific metrics.