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

Medical publication policies and guidelines offer a framework for best practices, but there may be situations when more than one approach seems reasonable. The primary purpose of “What Would You Do?” is to explore examples of such situations. With the limited information provided to interpret the scenarios, you may find yourself agreeing with one, more than one, or none of the proposed actions. And that’s the point ‒ you should debate, contemplate, and communicate (with a comment) before selecting your “best” answer. 

Now let’s find out how you responded and read through some commentary (for context only; not meant to be comprehensive) to the below scenario:

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.

Poll results represent a total of 91 responses.

The transparent presentation of pre-specified efficacy and safety endpoints in a fair and balanced manner is one of the core principles of proper clinical data reporting. When medical publication professionals feel there may be an imbalance that overstates efficacy, it should be flagged for discussion to ensure this is not the case.

Option D describes what is likely the most pragmatic approach to correcting a potential imbalance diplomatically because it enables the team to frame the flow of key takeaways for both efficacy and safety without necessarily calling out that the current draft may be leaning a bit too heavily towards efficacy outcomes. This is the main advantage of Option D over Option C (which is a bit more direct) and Option B (publication teams should encourage open scientific exchange over any concerns related to a manuscript instead of head-on “pushing back” against author recommendations, as this option suggests). Option A is not the recommended approach if there is a belief of an imbalance (and it may be more likely for publication professionals who have limited experience to simply accept author input without vetting the content appropriately).

For industry-sponsored studies, there are usually additional reviewers beyond the authors from functions such as R&D, clinical safety, regulatory, and medical affairs who serve as another line of defense to catch any imbalances in the reporting of results.  

Eric Y. Wong, PhD, MBA, ISMPP CMPP^TM, Johnson & Johnson Innovative Medicine

This article was prepared by the author in his personal capacity. The opinions expressed within are the author’s own and do not necessarily reflect the views of Johnson & Johnson Innovative Medicine.