Baseline Assessment

Question 1

Define “Baseline” in a clinical trial.

Answer 1

The status of a participant before the start of intervention.

Baseline data:

• can be from interview, questionnaire, physical examination, lab tests, and procedures
• categorical or numerical

Question 2

What are three uses of baseline data in a clinical trial?

Answer 2

1) Describe the population of the study (supplementary table 1) so that we know who the study applies to.
2) Determine if randomization generated balanced groups.
3) Used in statistical analysis to control for imbalances in groups.
4) Form basis for subgroup analyses