Clinical Trial Results Presentations: A Basic Guide
中國醫藥大學 安南醫院副院長
精神醫學及神經科學教授
Key Components for effectively presenting clinical trial results:
- CONSORT flow diagram (Figure 1)
- Shows participant flow through each stage of the trial
- Includes numbers assessed for eligibility, randomized, allocated to each group, followed up, and analyzed
- Baseline characteristics table (Table 1)
- Compares demographic and clinical characteristics between treatment groups at baseline
- Helps assess if randomization produced comparable groups
- Primary outcome results (Figure 2+)
- Graph showing change in primary outcome measure over time for each group
- Often uses repeated measures analysis or mixed models to assess differences
- Statistical methods:
- Chi-square tests for categorical outcomes (e.g. remission rates)
- T-tests or ANOVA for continuous outcomes at single timepoints
- Mixed models for longitudinal data with multiple timepoints
- Intention-to-treat (ITT) analysis to handle missing data
- Per-protocol analysis as secondary approach
- Safety/adverse event data
- Secondary outcomes
- Subgroup analyses (if pre-specified)
- Survival Analysis:
- Use Kaplan-Meier curves and log-rank tests for time-to-event data
- Apply Cox proportional hazards models for multivariate analysis
Key considerations:
- Use clear figures and tables to illustrate main findings
- Clearly state primary and secondary outcomes
- Report effect sizes and confidence intervals, not just p-values
- Include subgroup analyses if pre-specified
- Follow CONSORT guidelines for transparent reporting
- Discuss limitations and generalizability of results
This framework allows for systematic presentation of trial design, participant characteristics, and key efficacy and safety outcomes. Let me know if you would like me to elaborate on any part of this overview.
