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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.8K
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

5.0K
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...
5.0K
Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

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Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
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Trial and Error and Algorithm01:12

Trial and Error and Algorithm

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A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
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Relative Risk01:12

Relative Risk

2.2K
Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
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Factors Affecting the Risk of Infection01:26

Factors Affecting the Risk of Infection

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The hosts' susceptibility to infection depends on several factors. The integrity of the skin and mucous membranes helps protect the body against microbial attacks. When the skin is altered, the chance of infection, limb loss, and even death increases.
The integrity and count of the white blood cells help the body resist pathogens and fight infection. When impaired, it reduces the body's resistance to pathogens. The acidic pH levels of the gastrointestinal, genitourinary tracts, and skin...
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In Silico Clinical Trials for Cardiovascular Disease
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Risk-based Monitoring of Clinical Trials: An Integrative Approach.

Dimitris K Agrafiotis1, Victor S Lobanov1, Michael A Farnum1

  • 1Covance, the Drug Development Division of LabCorp, Princeton, New Jersey.

Clinical Therapeutics
|August 14, 2018
PubMed
Summary
This summary is machine-generated.

Risk-based monitoring (RBM) in clinical trials enhances oversight efficiency and effectiveness. This approach intelligently deploys resources, improving quality and reducing costs by focusing on critical data and processes.

Keywords:
RBMXcellerateclinical informaticsrisk-based monitoringstatistical monitoring

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Area of Science:

  • Clinical research methodology
  • Drug development processes
  • Regulatory science

Background:

  • Clinical trial monitoring is crucial for drug development, ensuring subject safety, data integrity, and protocol adherence.
  • A shift towards risk-based monitoring (RBM) is advocated by regulatory bodies and industry groups to focus oversight on critical study aspects.
  • Implementation challenges, including varied methodologies and technological limitations, have hindered widespread RBM adoption.

Purpose of the Study:

  • To present a holistic solution for implementing risk-based monitoring (RBM) in clinical trials.
  • To enable comprehensive risk assessment and mitigation at study, site, and subject levels.
  • To address the need for clearer RBM implementation strategies.

Main Methods:

  • Describing a solution integrating data access, advanced analytics, and existing technology infrastructure.
  • Applying this solution to assess and mitigate risks throughout clinical trial conduct.
  • Utilizing data from completed RBM studies over the past four years.

Main Results:

  • Demonstrated improvements in the efficiency and effectiveness of clinical oversight.
  • Measured enhancements across quality, timeline, and cost dimensions.
  • Evidence of superior outcomes from the implemented RBM methodology.

Conclusions:

  • The proposed RBM methodology significantly enhances the clinical oversight process.
  • Intelligent deployment of monitoring resources leads to lower costs.
  • The approach effectively directs attention to sites requiring the most support.