Level of Detail for Efficacy and Safety Data in a Clinical Study Publication?

You are a medical publication professional in a pharmaceutical company, working on a clinical trial publication for an investigational drug that has the potential to change clinical practice in the treatment of a life-threatening disease. Some of the authors are keen to emphasize the promising efficacy outcomes without, in your opinion, incorporating the same level of detail about certain adverse events. What would you do?

1. Follow the guidance of the authors and describe the efficacy outcomes in more detail than the safety outcomes.
2. Push back against the authors’ recommendation and report the efficacy and safety results in similar detail, providing more information on safety outcomes than proposed by the authors.
3. Point out to the authors that it is best practice to present the trial results in a balanced manner with efficacy and safety described to a similar extent, and then, if these authors persist in asking to emphasize efficacy over safety, follow their guidance.
4. Discuss with the authors how the trial results can be communicated to demonstrate the overall benefit to patients and describe the side effects to ensure that healthcare professionals and patients make informed decisions based on a holistic understanding of the drug’s effects.

This poll is now closed. Results will be posted in October 2025.