Measurements in Clinical Trials

When clinical trials are conducted, medical details of participants (but not their identities) are collected for the purpose of statistical analyses in a computer database together with the results of any measurements made*. Statistical analyses are then conducted to formally assess the outcomes of the trial. These analyses cover three areas of interest:

• Descriptive statistics:
  
• Demographic and baseline information.
  
  
• Inferential statistics:
  
• Efficacy.
• Safety.
  

* In cases of emergency it must be possible to identify a participant (even after the completion of the trial).