IN ONE SIMPLE SENTENCE
Planning and performing statistical analyses to answer the study questions.
What is this service?
After data cleaning, appropriate statistical methods are needed to understand what the findings actually mean. A few percentages or charts are not enough for a defensible scientific conclusion.
GOAL
Turn data into defensible conclusions and answer the study questions using appropriate statistical methods.
What can MICT do here?
Prepare the statistical analysis plan, calculate key measures, analyze subgroups and confidence intervals, assess trends and produce final tables and charts.
TYPICAL INPUTS
What we usually need to start
- Cleaned dataset
- Protocol / CIP
- Endpoints
- Study hypotheses and objectives
TYPICAL OUTPUTS
What this stage can deliver
- Statistical Analysis Plan (SAP)
- Statistical tables and figures
- Primary and secondary results
- Subgroup analyses
- Outputs for CSR, CER and PMCF
Important terms in plain language
Biostatistics
Application of statistical methods to medical and biological data.
SAP
The pre-specified plan describing which analyses will be performed and how.
Confidence Interval
A range that expresses uncertainty around an estimate.
Subgroup Analysis
Separate analysis of groups such as older users, women or people with diabetes.
Statistical Significance
A measure of how compatible an observed difference is with chance; it does not by itself establish clinical importance.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
A blood-pressure monitor may have acceptable average error while subgroup analysis shows larger errors in users with very large arm circumference.