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Related Concept Videos

Clinical Trials01:16

Clinical Trials

11.1K
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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Clinical Trials: Overview01:11

Clinical Trials: Overview

5.4K
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...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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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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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,...
520
Blinding01:11

Blinding

4.1K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Drug Discovery: Overview01:26

Drug Discovery: Overview

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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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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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Activating clinical trials: a process improvement approach.

Diego A Martinez1, Athanasios Tsalatsanis2, Ali Yalcin3

  • 1Department of Emergency Medicine, Johns Hopkins University, 5801 Smith Avenue Baltimore, Baltimore, 21209, MD, USA. dmart101@jhmi.edu.

Trials
|February 25, 2016
PubMed
Summary
This summary is machine-generated.

Streamlining clinical trial activation is crucial. This study uses network analysis and simulation to identify bottlenecks, suggesting efficiency gains in contract and budget development can significantly reduce trial activation times.

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Area of Science:

  • Clinical research administration
  • Process improvement methodologies
  • Health informatics

Background:

  • Clinical trial activation is often inefficient, characterized by high costs and lengthy timelines.
  • Previous research focused on identifying barriers and solutions for administrative delays.
  • This study integrates social network analysis and discrete-event simulation for enhanced process improvement.

Purpose of the Study:

  • To analyze the administrative process of clinical trial activation.
  • To identify key bottlenecks and participants in the activation workflow.
  • To model and evaluate potential process modifications for efficiency gains.

Main Methods:

  • Operational data from industry-sponsored clinical trials at the University of South Florida (July 2011-June 2012) were analyzed.
  • Value stream mapping described the process, social network analysis examined participant interactions.
  • Discrete-event simulation modeled the impact of process modifications.

Main Results:

  • The process involved 5 sub-processes, 30 activities, and 8 participants, with a mean activation time of 76.6 days.
  • Contract and budget development were identified as rate-limiting sub-processes.
  • Simulation showed increasing trial volume by 11% would extend activation time; improving contract/budget efficiency could reduce it by 28%.

Conclusions:

  • The developed analytic framework effectively identifies administrative barriers in clinical trial activation.
  • It facilitates the design and evaluation of improvement scenarios.
  • The framework's strength lies in its systems analysis approach, accounting for process variability and interdependencies.