Which data are typically included under efficacy data in a clinical trial report?

• A. Serious Adverse Events
• B. Endpoint analyses
• C. Source documents
• D. Audit findings

Answer: (B)

Efficacy data in a clinical trial report come from analyses of predefined endpoints that measure the treatment effect. These endpoint analyses capture how well the intervention achieved its intended benefit—things like changes in a primary outcome, response rates, or time-to-event results—and they provide the evidence that the study was designed to obtain about efficacy. Serious adverse events are safety data, describing harm or risk rather than benefit. Source documents are used to verify that data were collected and recorded correctly, supporting data integrity rather than providing efficacy outcomes. Audit findings relate to the conduct and quality controls of the trial, not to the efficacy of the treatment. So, endpoint analyses are the best representation of efficacy data in the report.