Reporting and Critical Review of Trial Results

What are clinical trials results?

The results of a clinical study or trial are all the data and statistical analyses generated during that clinical trial or study. Results include the following elements: 

• Description of trial population: the number of participants per treatment arm who started, completed, or dropped out of the trial.
  

• Baseline data: data collected at the beginning of a clinical trial. These data include demographics such as age and gender, participant characteristics such as height, weight, performance status, blood pressure, etc., and trial-specific measures such as disease characteristics, previous treatment, etc.

• Measures capturing the effect of the treatment on participants. For example, medicine activity in a Phase II trial, participant survival, changes in variables indicative of disease status and/or quality of life in Phase III and Phase IV trials. 

• Adverse events experienced by the trial participants related or not to the tested treatment e.g. pain, nausea and other untoward effects.