Your Easy Guide to Clinical Studies

Statistics is the discipline that deals with the collection, organisation, analysis, interpretation, and presentation of data.

 

Statistics is all about understanding numerical information, such as:

• Trends: observable pattern or direction in data (e.g. increase, decrease, or some other pattern) that can be quantified (e.g. the average global temperature has increased during the last decade)
• Relationships: a potential association between two or more variables (e.g. differences in salaries are related to the level of education)

 

A relationship can either be:

• Causal: occurs when a change in one variable causes a change in another variable (e.g. an increase in temperature causes a change in ice-cream sales)
• Non-causal: occurs when variables move together without a causal link (e.g. sales in ice creams and sunglasses are positively correlated (e.g. they tend to increase together). Still, this relationship does not imply causality

As a SP-INV, make yourself familiar with how statistics is used, such as to:

• Summarize data by providing summary measures like averages, percentages, and graphs
• Describe, make predictions, and draw informed conclusions (i.e. based on a study question).
• Disclose important inherent information that might otherwise be missed

References

ICH Topic E9 statistical Principles for Clinical Trials – see in particular

• 1.1. Background and Purpose