1.3: Trial Objectives and Endpoints

Question 1

Describe endpoints:

Answer 1

• Quantitative measurements implied or required by the trial objectives
• They are determined in each study subject

Question 2

Hard vs Soft endpoints:

Answer 2

Hard:

• Well defined and reliable
• No subjectivity (objectively measured)
• e.g. death. presence or absence of a particular symptom, lab measurements

Soft:

• Difficult to define, subjective measures
• e.g. degree of satisfaction with treatment, amount of pain

Question 3

Continuous response data: Clinical outcome of interest

Answer 3

• Typically summarised in terms of group means or medians
• Clinical outcome of interest is often the difference (D) between the groups
• D hat denoted the estimated group difference