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

Bioavailability Study Design: Healthy Subjects Versus Patients

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,...
Hazard Ratio01:12

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...

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E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
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General practice-based clinical trials in Germany - a problem analysis.

Eva Hummers-Pradier1, Jutta Bleidorn, Guido Schmiemann

  • 1Department of General Practice/Family Medicine, University Medical Centre Göttingen, Humboldtallee 38, 37073, Göttingen, Germany. eva.hummers-pradier@med.uni-goettingen.de

Trials
|November 10, 2012
PubMed
Summary
This summary is machine-generated.

Clinical research in German primary care faces significant barriers due to systemic issues and lack of resources. Addressing these challenges requires developing structural and procedural prerequisites for better implementation of clinical trials.

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Area of Science:

  • Health Services Research
  • General Practice
  • Clinical Trials

Background:

  • Clinical trials and comparative effectiveness studies are rare in German primary care despite recognized value.
  • A network of German academic general practice researchers investigated reasons for this low implementation.

Purpose of the Study:

  • To analyze barriers to clinical trials in German primary care.
  • To define structural and procedural prerequisites for improved implementation.

Main Methods:

  • Comprehensive literature review.
  • Expert group discussions.
  • Problem analysis and definition of prerequisites.

Main Results:

  • Germany prioritizes basic science over clinical research; funding is competitive and favors innovation.
  • Academic general practice is underdeveloped; GPs lack research time, funding, training, and support.
  • Compulsory Good Clinical Practice (GCP) training is required.

Conclusions:

  • Numerous deeply rooted barriers hinder clinical research in German general practice.
  • Systemic and academic traditions pose challenges.
  • Recent developments in the German research landscape offer potential for positive change.