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.
A medical writer worked with authors to develop a congress abstract for a Phase 2 clinical study. Two days before submission, the lead author requests an additional ‘medical narrative’ statement to be added detailing the management steps and time to resolution of an adverse event seen in one patient. What would you do?
A. It is too late to add anything to the abstract, and you are already at the character limit. Go ahead and submit the abstract since you already received the lead author’s approval email.
B. It is too late to add anything to the abstract, and the adverse event is too important to exclude from the submission. Propose to the lead author and internal stakeholders that submission of the abstract be postponed and retargeted for the next appropriate congress instead.
C. It is critical to amend the abstract. Contact the relevant stakeholders (Clinical Trial Lead, Biostats authors) immediately to obtain the relevant information. Prepare to edit the abstract, re-circulate for all-author approval, follow up with all authors, and submit the abstract – hopefully, you will still meet the deadline!
D. Connect and discuss with relevant stakeholders to understand the request and criticality of data inclusion. Propose to lead author that the submission be completed with the abstract as is, with the additional data to be generated and included within the congress poster/oral presentation, if accepted.
This poll is closed. Poll results will be released in May 2024.