Efficacy Results Section
ICH E3 provides a dedicated efficacy evaluation/results structure within a clinical study report, including analysis populations, measurements, statistical/analytical presentation, and efficacy conclusions. Keep this scoped to regulatory CSR efficacy reporting; ordinary journal Results sections may organize the same evidence differently and should follow the target publication standard.
An Efficacy Results section presents the study’s efficacy analyses and findings in the structure required for a clinical study report.
Key details
Important caveats
Scope Boundary
Keep this scoped to regulatory CSR efficacy reporting; ordinary journal Results sections may organize the same evidence differently and should follow the target publication standard.
Further guidance
Content
Present efficacy populations, endpoints/measurements, analyses, estimates and supporting tables/figures in a sequence that lets reviewers connect methods to findings.
Purpose
An Efficacy Results section presents the study’s efficacy analyses and findings in the structure required for a clinical study report.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E3 Structure and Content of Clinical Study Reports (opens in a new tab)U.S. Food and Drug Administration · FDA-hosted ICH E3 guidance defining the structure and content of a core clinical study report