What is the recommended approach when presenting conclusions about efficacy in the summary?

• A. Make broad promises about therapeutic benefit
• B. Emphasize favorable results while ignoring negatives
• C. Present balanced conclusions with reference to predefined endpoints and limitations
• D. Use marketing language

Answer: (C)

When presenting efficacy conclusions, the summary should be balanced and tied to what was defined in advance. The best approach is to state conclusions in the context of predefined endpoints, while also acknowledging study limitations. This means reporting the actual results—effect sizes, confidence intervals, and p-values as appropriate—and explaining whether the endpoints were met, partially met, or not met. It also involves candidly discussing limitations that could affect interpretation, such as sample size, missing data, protocol deviations, population characteristics, and generalizability. This objective, transparent framing ensures the conclusions reflect the data and the plan, rather than overstating benefits or downplaying downsides.

Overstating therapeutic benefit, selectively highlighting favorable results while ignoring negatives, or using marketing language would mislead readers and violate GCP principles, which require unbiased, accurate, and complete reporting.