What the guideline expects for and of the medical writer
Good Publication Practice sets out what should and should not happen to a professional medical writer on a company-sponsored publication: the writer is treated ethically and enabled to work ethically, is agreed to by the authors before the project starts, joins their meetings and working group, works under their direction from before the outline, may be an author on the same terms as anyone else, leaves the final data check to the authors, and is disclosed. Applying it well takes familiarity with the whole guideline and with the setting it is applied in.
The writer's place in the 2022 edition
Under the general principles for ethics and good publication practice in its main body, the 2022 edition makes clear that professional medical writers should be treated ethically, enabled to follow ethical practice and able to do their work ethically. The guideline's authors discussed whether this needed saying at all, and decided that the fact they were having the discussion meant it was probably safer to say it than not. One speaker on the edition includes medical editors in what it expects of the professional medical writer. Following on from GPP3, the edition continues to emphasise the professional roles of medical writers, and it states that medical writers enhance the quality of publications. Its supplement carries practical guidance for a writer's day-to-day work in several sections, including Section B on publication professional roles and professional development, Section D on publication steering committees, Section F on publication working groups, Section G on authorship and contributorship determination and Section H on the publication process.
Agreeing to the writer's involvement
The authors must agree to work with a writer before the start of the project, and the employment of professional writing support should be agreed by the authors (Supplement Section G). A writer should not be employed or engaged before the team has agreed to their involvement, so no medical writer should arrive at a job to find that the people there are surprised to see them, or are not willing or eager to work with a writer. The roles of medical writers, along with those of authors, other contributors and reviewers, should be defined prospectively (Supplement Section D).
Meetings and the working group
The writer should be included in the appropriate meetings, such as kick-off and data dissemination meetings, so that they can capture the authors' views and directions (Supplement Sections F and H). Once the authors have been gathered and are about to discuss how the publication will be written up, the writer should be in the room. The writer is a full member of the working group. They should receive adequate resources and information rather than be left to piece a manuscript together on their own, and they should receive information about their own role in the writing, not only provide it to others.
Direction from the authors
Medical writers should work under the authors' direction and get guidance rather than write things up without it. The authors must provide that direction and an initial outline to the writer. Under GPP3, the writer must receive direction from the authors at the earliest possible stage, for example before the outline is prepared. Projects sometimes land in a writer's lap once the process is under way, so one writer welcomed the 2022 edition's recommendation that the writer be included earlier. In that writer's experience, a writer brought in late may not be sure who is leading the work when there is a principal investigator and someone else steering, and it sometimes falls to the writer to act as an intermediary in conflicts.
A co-author of GPP3 who led its professional medical writer section objected in 2016 to the drafting process set out in an article in the previous issue of a medical writing journal. As she read it, the process did not bring the author in until the writer had had a content outline approved by the client, had written a shell draft with bulleted text for the introduction and discussion and text paragraphs for the methods and results, and had had that shell draft approved by someone the article did not name. She noted that the article never explicitly stated that the authors must give final approval of the manuscript, and did not include authors in its list of approvers. She held that the process description was at best ambiguous and at worst clear, in which case readers who followed it could risk non-compliance with GPP3, and that omitting early author direction and input is not acceptable even if inadvertent. Consistent with COPE guidelines, she asked for the article to be revised and a correction published.
The article's authors replied that they had not intended to undermine the role of authors. They described the article as proposing a project management process for publication writing projects, with special emphasis on work in agencies, focused on the business aspects, process and day-to-day activities of contract research organisations or agencies, and as in no way an extension of publication writing guidelines. They pointed to steps in the article that bring authors in early. Against the risk of minimal data sources in the pre-drafting phase, the article proposed a kick-off meeting with the authors to get credible data sources and decide the direction and flow of the manuscript. Its initiation section said the scope should be discussed in great detail with the client so that both parties' expectations are aligned, which its authors took to indicate the early involvement of stakeholders including authors. They explained that "client" was a collective term for stakeholders in agency work, and that the researchers, statistics head and clinical team head among the final approvers are potential authors. They allowed that, because terms such as authors, researchers, clients and approvers are used interchangeably from a contract research organisation's standpoint, the article may have led to confusion and misinterpretation, and they agreed with the editor's suggestion to make minor changes to address the objection. The journal's editor agreed with the objection and announced that the original article on the journal website would be replaced with a revised version addressing the editor's and the objector's concerns.
Authorship and the final data check
Medical writers, as with all publication contributors, qualify as byline authors if they meet the authorship criteria, which are applied to the professional writer on the same terms as to every other stakeholder involved (Supplement Section G). A writer may be listed as an author on fulfilling all the ICMJE criteria, and is not disqualified from authorship by paid employment as a medical writer. The authors must perform the final data check to ensure the publication's quality and accuracy, and the professional writer should not be assigned the final data integrity check. In the supplement's terms, a writer who is not a byline author should not be asked to perform it (Supplement Sections F and H), which helps ensure adherence to the ICMJE authorship criteria. The point draws many questions, and one reason for it is accountability: authors taking accountability for the work need to be the last people who check it and cannot delegate that responsibility, because their names are on the work, and the guideline does not want to interfere with their ability to be accountable for it.
Disclosure and professional conduct
Medical writing support needs to be disclosed, and publications should include the writer's name, professional qualifications, affiliation and funding source. These are typically the minimum, along with any other information the journal or conference requires (Supplement Section H). Writers should not use their personal social media accounts to share information on company-sponsored research publications. They should engage in professional development and in sharing best practices (Supplement Section B). They should also engage in formal training offered by relevant organisations, such as EMWA, AMWA and ISMPP.
Applying the guideline in practice
One assessment of the 2022 edition for medical writers concluded that it provides important clarifications on the transparency, recognition, roles and responsibilities of medical writers, and that medical writers should be aware of these updates and communicate them to their clients and collaborators.
Medical writers are highly encouraged to keep the guideline on hand as a key reference and to consult it when questions or uncertainties arise at work: it may not give the exact answer for every situation, but its principles and processes may provide an approach to developing a solution. One of the 2022 edition's coauthors recommends that freelance writers new to the guideline be closely familiar with the entire document, especially its ethical and quality principles, rather than focus on particular sections of it, and hopes it becomes an essential reference for all medical writers. For medical editors and those who work with them, the detailed publication process the 2022 edition describes can help identify where an editor's insights and input are needed.
The same coauthor sees the global nature of publications as a challenge for adopting the 2022 edition, in navigating cultural differences: authorship practice in another culture may require more nuanced handling, including how authors are asked for feedback and approval, and anticipating problems and finding solutions may require a good understanding of the culture and practice of the region concerned. Writers supporting authors and sponsor staff in China through the obvious and less obvious elements of the guideline's second edition, GPP2, held that successful navigation requires detailed knowledge of GPP2, experience of applying it in China, and cultural sensitivity.