Statistical methods safety

  • How do you select an appropriate statistical technique?

    Selection of appropriate statistical method depends on the following three things: Aim and objective of the study, Type and distribution of the data used, and Nature of the observations (paired/unpaired)..

  • What is the role of statistical techniques?

    Statistical methods involved in carrying out a study include planning, designing, collecting data, analysing, drawing meaningful interpretation and reporting of the research findings.
    The statistical analysis gives meaning to the meaningless numbers, thereby breathing life into a lifeless data..

  • An event study, also known as event-history analysis, employs statistical methods, using time as the dependent variable and then looking for variables that explain the duration of an event—or the time until an event occurs.
  • For a statistical test to be valid, your sample size needs to be large enough to approximate the true distribution of the population being studied.
    To determine which statistical test to use, you need to know: whether your data meets certain assumptions. the types of variables that you're dealing with.
Mar 20, 2020Conclusion. The review demonstrated that statistical analysis of safety data in anti-malarial drugs for malarial chemoprevention in pregnancy 

Characteristics of The Reported Safety Data

Over half of the trials (10 trials, 55.6%) reported that they collected safety data using a combination of scheduled and non-scheduled visits (Table 2), while a third of the trials (6 trials, 33.3%) did not specify the safety data collection approach used.
The median retention rate (based on the defined efficacy outcome reported for respective tria.

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Characteristics of The Trials

The trials included in this review were conducted in Oceania (2 trials, 11.1%) and sub-Saharan Africa (16 trials, 88.9%) regions.
The 18 RCTs reviewed recruited 26,281 pregnant women with a median sample size of 374 (interquartile range (IQR): 173, 648) women per treatment arm in a trial.
Thirteen trials (72.2%) recruited more than 200 patients per.

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What is a safety methodology?

As safety knowledge is one of the most important asset of modern organisations, the methodology aims not only at analysing safety issues, but also at documenting them as experience feedback for the whole organisation.

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What is statistical analysis of safety data in clinical trials?

Statistical analysis of safety data in clinical trials is characterized by a challenge of multiple and related endpoints measured over time.
The safety endpoints may include:

  1. clinical and laboratory defined AEs

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