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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.2K
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

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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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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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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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Stereotypes, Prejudice, and Discrimination02:55

Stereotypes, Prejudice, and Discrimination

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Humans are very diverse and although we share many similarities, we also have many differences. The social groups we belong to help form our identities (Tajfel, 1974). These differences may be difficult for some people to reconcile, which may lead to prejudice toward people who are different. Prejudice is a negative attitude and feeling toward an individual based solely on one’s membership in a particular social group (Allport, 1954; Brown, 2010). Prejudice is common against people who...
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Uncertainty in Measurement: Accuracy and Precision03:37

Uncertainty in Measurement: Accuracy and Precision

100.5K
Scientists typically make repeated measurements of a quantity to ensure the quality of their findings and to evaluate both the precision and the accuracy of their results. Measurements are said to be precise if they yield very similar results when repeated in the same manner. A measurement is considered accurate if it yields a result that is very close to the true or the accepted value. Precise values agree with each other; accurate values agree with a true value. 
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Purification of a High Molecular Mass Protein in Streptococcus mutans
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Group B Streptococcus: Trials and Tribulations.

Hannah G Davies1, Clara Carreras-Abad, Kirsty Le Doare

  • 1From the Paediatric Infectious Diseases Research Group, Institute of Infection & Immunity, St George's University of London, London, United Kingdom.

The Pediatric Infectious Disease Journal
|June 18, 2019
PubMed
Summary
This summary is machine-generated.

A maternal Group B Streptococcus (GBS) vaccine could prevent infant deaths and disease. Alternative licensure pathways are proposed due to low GBS incidence, focusing on safety and protection correlates.

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Area of Science:

  • Neonatal Health
  • Vaccinology
  • Maternal Health

Background:

  • Group B Streptococcus (GBS) caused 319,000 neonatal cases and 90,000 infant deaths in 2015.
  • GBS is linked to maternal sepsis, preterm birth, stillbirth, and neonatal encephalopathy.
  • Neurologic impairment is a significant issue for GBS survivors.

Purpose of the Study:

  • To explore alternative pathways for Group B Streptococcus (GBS) vaccine licensure.
  • To address the challenges of conducting large Phase III efficacy studies for GBS vaccines.
  • To propose a strategy involving correlates of protection and safety evaluations for regulatory approval.

Main Methods:

  • Reviewing current GBS disease burden and prevention strategies.
  • Evaluating the feasibility of traditional Phase III vaccine trials.
  • Proposing alternative regulatory pathways for GBS vaccine approval.

Main Results:

  • Intrapartum antibiotic prophylaxis is not feasible in many low-resource settings.
  • Maternal vaccination offers a potential strategy to reduce GBS-related maternal and neonatal morbidity and mortality.
  • Alternative licensure pathways, including correlates of protection and safety studies, are proposed.

Conclusions:

  • A maternal GBS vaccine could significantly reduce global infant mortality and disease.
  • Alternative regulatory pathways are necessary for GBS vaccine licensure due to low disease incidence.
  • Post-licensure studies will be crucial for evaluating real-world vaccine effectiveness.