KEY TAKEAWAY

• Open discussion between stakeholders is the key to maintaining transparency and reaching consensus.

Medical writers must often juggle multiple—and sometimes conflicting—requests from various stakeholders, all the while adhering to Good Publication Practice (GPP) guidelines. In a recent poll for their MAP newsletter, the International Society for Medical Publication Professionals (ISMPP) asked respondents how they would handle the resurrection of a two-year old real-world evidence (RWE) manuscript. The scenario required respondents to balance the new project owner’s desire to publish promptly with the lead author’s request for additional analysis and author list changes. Dr Eric Y. Wong (Johnson & Johnson Innovative Medicine) summarised and discussed the results of the poll.

The poll asked: You are the medical writer on a real-world evidence (RWE) manuscript that was initiated 2 years ago. The RWE analyses utilise the services of a third-party data analytics company. At first draft stage, the project was put on hold. The project owner has now left the organisation and the manuscript has been transitioned to a colleague. The lead author would like to perform additional analyses and include one of their colleagues as an author. Meanwhile, the new project owner/client would like to finalise and submit the article as soon as possible.

What would you do?

The results of the poll, which was answered by 131 people, were:

• 87.8% – Convene a conference call between all the authors and relevant internal stakeholders to take a consensus on the best way forward. If the new author is added, all authors need to agree, and the new author must review and approve the manuscript draft.
• 10.7% – Explain the value of performing additional analyses (and spending budget with the third-party analytics company) to the new project owner/client, although this will introduce further delays. Include the new author after aligning with all authors/stakeholders.
• 1.5% – Recommend to the lead author to continue with the manuscript in its current state, as the priority for the project owner is to publish as soon as possible and without inclusion of new author.
• 0% – The additional analyses look simple enough. Carry out the calculations in Excel and circulate the updated draft for final approval without including the new author.

Dr Wong concurred with the consensus opinion. A conference call would allow stakeholders—in this case authors and client leads—to discuss, deliberate, and document a range of options and reach consensus. Authorship changes are permissible so long as ICMJE criteria are met; however,  the project sponsor may lack the budget or timeline flexibility for additional analysis. Dr Wong emphasised that any limitations or mitigations (ie, authors agreeing to take on extra work to support the analysis, or timeline excursions) should be clearly documented.

Some respondents chose the option to explain the value of performing additional analysis (despite potential delays). Dr Wong acknowledged that this approach could be a precursor to a conference call. By contrast, he suggested that proposing that the lead author simply accept the manuscript be published as is would exclude other authors’ views. Dr Wong felt that the final option was inappropriate, invalid, and “off-the-cuff”, as only statisticians (or other appropriately trained professionals) should conduct calculations, which may or may not require a new author.

Dr Wong concluded by highlighting the role of the publication professional in stakeholder mediation. As ever, open discussion is the key to success.

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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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KEY TAKEAWAYS

• In a recent ISMPP poll, medical publication professionals were asked “What would you do?” when presented with a challenging hypothetical scenario.
• In the scenario, a manuscript had been inadvertently submitted to a predatory journal. The majority of respondents opted to seek legal advice, attempt to retract the manuscript (even if this was made difficult by the predatory journal), and submit the article elsewhere.

Despite widespread recognition that predatory journals are a threat to research credibility, there is no consensus on the best course of action if study sponsors or authors fall prey to them. A recent poll from the International Society for Medical Publication Professionals (ISMPP) asked publication professionals how they would deal with this sticky situation. Dr Eric Y Wong (Janssen) discussed the poll’s findings in the MAP newsletter, providing additional insight and recommendations.

The poll asked: You are a medical publication professional and have been supporting a client with a secondary manuscript for a Phase 3 study. You recommended target journals and worked with the author team throughout the submission process. After publication, it becomes apparent that the manuscript was submitted to a predatory journal. Unfortunately, the journal has no retraction policy and asks for a large sum of money in processing fees to retract the article. The authors have signed a copyright agreement giving the journal full copyright of the manuscript.

What would you do?

The results of the poll, which was answered by 72 respondents, were:

• Request the editorial office to retract the manuscript and seek legal advice from the sponsor company; at the same time plan a resubmission to another journal: 56.9%
• Suggest that the authors add some new and substantive data to support submission to a new, reputable journal as a secondary publication: 20.8%
• Working with co-authors, write a response to the journal highlighting their policies and exposing them as a predatory journal and showcase this letter via authors’ social media channels: 16.7%
• Recommend against retraction as this can negatively impact reputation, and review the copyright agreement to determine if you are able to submit elsewhere, such as to a preprint server: 5.6%

Dr Wong agreed that the option selected by most respondents was the most reasonable course of action in this difficult situation. Seeking legal advice is vital, particularly as copyright ownership is in question. While paying a retraction fee may be the quickest route to an initial resolution, Dr Wong warned of potential challenges in recouping this fee at a later stage, as contact and personnel details for predatory publishers are “often not available or fictitious”. He remarked that the other poll options would not resolve the primary concern for the authors, ie, that doubt may be cast on study credibility due to association with a disreputable journal.

Prevention is better than cure; hence, despite the challenges associated with identifying predatory journals, Dr Wong recommends that medical publication professionals maintain a comprehensive list of legitimate journals. Moreover, Good Publication Practice guidance states:

“If the credibility of a journal or conference cannot be reasonably ascertained, it should be avoided.”

Dr Wong therefore calls on publication professionals to remain vigilant and to carefully assess new journals.

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