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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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...
Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
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Unlocking Data for Clinical Research - The German i2b2 Experience.

T Ganslandt1, S Mate, K Helbing

  • 1Center for Medical Information and Communication, Erlangen University Hospital , Erlangen, Germany.

Applied Clinical Informatics
|April 26, 2013
PubMed
Summary

The i2b2 platform is suitable for clinical data querying in German medical research. Integrating privacy tools enhances data protection, with development tools simplifying data import from standard formats.

Keywords:
Information Storage and RetrievalMedical Record SystemsSingle-Source

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Area of Science:

  • Medical Informatics
  • Clinical Research Data Management

Background:

  • Clinical care data is increasingly utilized for research.
  • The i2b2 platform facilitates data integration and querying for clinical users in the US.

Purpose of the Study:

  • Assess i2b2 applicability in Germany for use cases, functionality, and privacy tool integration.
  • Evaluate i2b2's suitability for networked medical research in Germany.

Main Methods:

  • Tested i2b2 v1.4 with four research scenarios, including data import and ontology generation.
  • Developed setup/administration tools and an extraction tool for CDISC ODM data.
  • Implemented interfaces for TMF privacy enhancing tools (PID Generator, Pseudonymization Service).

Main Results:

  • Successful data import from various sources and i2b2 ontology generation.
  • Seamless integration of TMF privacy tools without platform modification.
  • Identified limitations in query performance compared to native SQL and for temporal queries.

Conclusions:

  • i2b2 is a viable platform for clinical data query tasks in German networked medical research.
  • Integrated privacy tools support data protection compliance.
  • Simplified setup and import tools, like for CDISC ODM, can lower entry barriers.