KEY TAKEAWAY
- When faced with an impending congress deadline, open lines of communication with all relevant stakeholders are critical to ensure conference abstracts are accurate and objective representations of scientific data.
The results of a clinical trial are often shared publicly for the first time as a conference abstract. As medical writers, we are frequently faced with ensuring accurate and transparent reporting of the trial results in the abstract, while meeting tight congress submission deadlines. A recent poll in the International Society for Medical Publication Professionals (ISMPP) MAP Newsletter asked publication professionals how they would react to a last-minute request to add in details of an adverse event to an abstract reporting the results of a clinical trial. Dr Eric Y Wong (Johnson & Johnson Innovative Medicine) broke down the results of the poll and provided additional perspective and recommendations.
The poll asked: 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?
The results of the poll, which was answered by 67 people, were:
- 88.1% – Connect and discuss with relevant stakeholders to understand the request and criticality of data inclusion. Propose to the 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.
- 10.4% – 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.
- 1.5% – 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.
- 0% – 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.
Analysing the results, Dr Wong agreed with the consensus, noting that proposing the abstract be submitted ‘as is’, with the additional data to be reported in the final presentation, would be the recommended approach. Amending the abstract to include additional detail for the adverse event could give too much emphasis to a single patient’s experience and would not generally be appropriate for an abstract intended to provide an overview of the trial’s efficacy and safety results. With 2 days to the abstract deadline, Dr Wong thought there was ample time to resolve the situation and therefore postponement of the submission was not necessary. Encouragingly, none of the respondents thought that submitting the current version, which does not currently meet author approval, was a valid approach.
In summarising, Dr Wong stated the need for all involved parties to be engaged to develop an abstract that is representative of the trial results as a whole. Publication professionals can refer to any relevant company policies or steering committee charters to determine appropriate next steps if escalation is required.
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