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Clinical Trials

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: Overview

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...

Preclinical Development: Overview

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...

Methods of Documentation V: CBE

Methods of Documentation V: CBE

Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...

Hazard Ratio

Hazard Ratio

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 evaluating a...

Methods of Documentation VII: EMR

Methods of Documentation VII: EMR

Electronic Medical Records (EMRs) primarily center around electronically documenting patients' health information within a single healthcare organization or practice. They contain essential clinical data related to a patient's medical history, diagnoses, medications, treatment plans, lab results, and other pertinent information relevant to the specific encounter or episode of care. EMRs are designed to streamline documentation and workflow processes within individual healthcare settings,...

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Related Experiment Video

Updated: Jun 10, 2026

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

[Searching clinical trials registries: procedure and documentation].

Elke Hausner¹, Thomas Kaiser

¹Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Dillenburger Strasse 27, 51105 Köln. elke.hausner@iqwig.de

Zeitschrift Fur Evidenz, Fortbildung Und Qualitat Im Gesundheitswesen

|August 13, 2010

Summary

Searching clinical trials registries is crucial for systematic reviews to find unpublished drug data. This guide details effective search strategies and registry selection for researchers.

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Area of Science:

Pharmacovigilance
Clinical Trial Data Management
Evidence-Based Medicine

Context:

Systematic reviews require comprehensive data, including unpublished findings.
Clinical trial registries are underutilized despite their importance for identifying all relevant studies.
Challenges include registry heterogeneity, variable quality, and limited search functionalities.

Purpose:

To highlight the importance of searching clinical trials registries for systematic reviews.
To describe the German Institute for Quality and Efficiency in Health Care (IQWiG)'s approach to registry searching.
To provide guidance on selecting registries, conducting searches, and documenting the process.

Summary:

This paper discusses the challenges and methods for searching clinical trials registries to locate unpublished drug data.
It outlines IQWiG's systematic approach, including registry selection, search execution, and data selection criteria.
The goal is to assist researchers in performing thorough searches of clinical trial registries.

Impact:

Enhances the completeness and reliability of systematic reviews by including unpublished data.
Improves the quality of drug assessments and health technology evaluations.
Provides a practical framework for researchers to navigate and utilize clinical trial registries effectively.