Collaborative writing

A document with several authors has to be set up and steered to a finish: someone leads it, the calendar and the storyline are agreed before drafting begins, the scientific decisions and the disagreements over them have a process for settling them, each author's part of the drafting is set, the authors' several styles are kept to one voice, and the authors' review is brought to a close.

The writing team

Medical writing is often done in teams, and in research various people can bring different abilities to one: expertise in research methods, access to subjects, grant-writing experience, personal contacts in grant-funding agencies, and statistical skills. ¹ A writing group may be clinicians with similar abilities and experience, or may combine the young person with ambition and energy, the mid-level professional who knows how to get the job done, and the senior person whose participation helps assure eventual publication. ¹ Writing as a team has other advantages: when a member shares a good writing or research idea with others on the team, one of them is likely later to have a good idea of their own, in which the member might be included, and in this way the members gain writing experience and entries on their CVs, and their publication successes help advance medical knowledge and understanding. ¹ When everyone on the team has a task vital to the project's success, no one wants to let the group down, which one sociology professor called a group effect and which helps keep the writing project moving. ¹

It is not possible to write with everyone, and a writer does not always get to choose whom they write with. ²

A team in regulatory writing is a group of people assigned to a project, each with a particular responsibility or competency, such as safety scientist, toxicologist or regulatory partner, and in a big pharmaceutical company its members may be at different sites and in different time zones. ³ Most documents a regulatory writer works on require contributions from different team members, and many are developed in a team context, with meetings or teleconferences to discuss the salient points and resolve issues, and it helps a writer to have a good feel for team dynamics. ³

Ground rules and leadership

Every writing team has implicit rules for how each person will behave and contribute, and some groups have more explicit ones. ⁴ One set of suggested guidelines for a writing team is this: ⁴

1. Choose a leader. The leader is usually the one with the good idea and the one who calls the meetings, and need not be the most senior person but must have a strong commitment to the project.
2. Agree to regular meetings, perhaps monthly or every two weeks; the frequency matters less than that the meetings are accorded priority on everyone's schedule. Every member must show up or at least send a progress report, and if someone misses several meetings, the group must question that person's commitment.
3. Decide on the role of each member. The key person is the one who will lead the writing and who in most cases composes the first draft from everyone's contributions. All members then submit revision suggestions, and in an efficient team the lead writer has discretion to accept or reject them.
4. Establish deadlines and stick to them. Breaking a writing project into achievable deadlines makes it seem much more manageable. An admittedly tight schedule for a review article might have the data collected by the end of month 1, the outline by the end of month 2, the first draft by the end of month 3, the second draft by the end of month 4, a third revised draft finished and read by peer reviewers by the end of month 5, and the final draft completed and sent in month 6.
5. Decide early on the order of authorship.

⁴

Ten suggested rules for collaborating on multi-authored papers are these: ⁵

1. Build the writing team wisely.
2. Provide leadership when taking the lead.
3. Create a data management plan.
4. Jointly decide on authorship guidelines.
5. Decide on a writing strategy.
6. Choose digital tools to suit the team's needs.
7. Set clear timelines and adhere to them.
8. Be transparent throughout the process.
9. Cultivate equity, diversity and inclusion.
10. Consider the ethical implications of co-authorship.

⁵

Collaborative writing projects often stir up a mix of emotions in the writers tasked with completing them: they can provide an opportunity to learn new skills, generate new ideas and gain new perspectives, but negative feelings can overwhelm those involved and hinder the writing process. ⁶ Strategies for three key phases of the writing process can help rein in those negative emotions. ⁷ Planning should take a project-management approach: a feasible schedule that takes the project's scope, team members' work styles and their prior obligations into consideration; a file-naming convention the team agrees on; an organised storage structure, with older versions of files archived and the most up-to-date version of a document stored in each version folder; and a strong leader who can take on responsibility. ⁸ The leader's general duties include managing deadlines, updating team members, scheduling and directing meetings, combining drafted sections, coordinating with editors, proofreading, submitting the final product and following up with the client. ⁸

In one writer's view, a medical writer is more realistically involved somewhere in the middle of a project, or comes in once the action is over and relates second-hand what was done, why, and why it matters, which is not the ideal pattern for medical writers and authors to follow. ⁹ The best model in that view is one in which the writer is involved from the beginning of the project, with a strong project leader who keeps it on course and does not tolerate nonsensical digressions, participants who have all given their consent, and a kickoff meeting at the start. ⁹

The kickoff meeting

A publication kickoff meeting is held between a medical writer and the members of the team drafting a manuscript before any writing is done. ¹⁰ It sets a clear direction, so that the writer knows what their responsibilities will be and the authors know what they can expect from the writer. ¹⁰

The topics a publication kickoff meeting can cover are these, though not every meeting needs all of them: ¹⁰

• Content. With all the authors present, pinpoint what the manuscript will include: the objectives, what data go in, and whether there are enough.
• Sharing of data. Before the meeting, ask the project manager how familiar the authors are with the data. If they are not familiar with it, it may help to discuss it at the meeting, and a writer who lacks the expertise to present it can ask the biostatistician or another colleague to do so.
• Authorship. Cover the criteria for authorship, the proposed author list and the order of authors, since investigators may not know authorship guidelines such as the ICMJE's and GPP3 or the distinction between naming someone as an author and in the acknowledgements. Before the meeting, check with the project manager or someone who knows the investigators well whether the order of authors might be contested.
• Medical writing support. If the authors want it, define at the start what the writer's responsibilities are: writing, editing, help with figures, outlining and drafting, involvement at all stages, or finding and gathering references; whether quality control is wanted, and to what degree; and who will submit and who will revise.
• Target journal. Author teams do not always know where to submit, so bring a list of four to six journals with details on each, such as audience, rejection rate, Impact Factor, and limits on words, tables and figures. Authors who see something that granular and concrete are more open to discussion.
• Publication policies and processes. Educate the authors on the company's or organisation's publication policies, emphasising that they exist to ensure the highest standards in medical publication, for example by requiring all authors to approve the manuscript before submission and by prohibiting ghostwriting.
• Timelines. Consider setting both soft and hard deadlines, honestly estimating the time needed to revise and review. Discuss schedules, and designate delegates to cover an author who is out of the office or has conflicting work.

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A medical writer is expected not only to draft the manuscript but also to drive the overall project, from preparing for and running the kickoff meeting or teleconference to addressing the final peer review. ¹⁷ Forms, including Gantt charts, should be distributed at the kickoff to remind participants of their roles and to facilitate submission of the final manuscript to the journal. ¹⁷ The kickoff lets the authors, the research and publication team, the writer, the project manager and the medical editor decide who will be the corresponding author and which journal best fits the research, and it answers why the team is reporting the findings and how it will organise and divide the labour to submit the manuscript. ¹⁸ Disclosure forms should be circulated there to facilitate submission, which can be labour-intensive; the disclosure form is distributed prospectively but can be completed only retrospectively, to ensure that all four ICMJE criteria for authorship have been met. ¹⁸ The writer should schedule one-to-one time with the corresponding author to become conversant with the key issues of the research and with how to engage the journal's readers. ¹⁸

Following up with the participants after the kickoff is essential, with minutes sent to all team members within five days that give the participants, the meeting's date, time and objective, the key decisions, the action items, and the outstanding items with their due dates. ¹⁶ The minutes serve both those who missed the meeting and the company's documentation. ¹⁶

The calendar

An editorial calendar circulated at the kickoff aligns everyone's expectations, lets the timelines be adjusted as necessary and secures buy-in to key roles, responsibilities and review dates. ¹⁸ One such calendar runs a 30- to 36-week publication cycle through planning and kickoff, drafting, editorial and author review, internal review, submission, peer-review responses, revision and resubmission, with a presubmission inquiry around week 2, initial submission around week 16 and publication around weeks 30 to 36. ¹⁸ Whenever possible, colleagues should have about the same amount of time to review a manuscript as the writer took to draft or polish it. ¹⁸

One lead author, most of whose many publications had multiple authors and input from large multidisciplinary teams, does not consider a project finished until it is published, and sets aside time to work on papers. ^{19, 20, 21} She looks ahead at the coming weeks for periods in which to concentrate on drafts or outlines or to arrange meetings with collaborators and co-authors, and many of her outlines and first drafts were put together on aeroplanes. ²¹ Key opinion leaders and subject-matter experts are usually busy, so a manuscript that needs their input has to be planned well ahead. ²¹

In the past, a drug company would hand over the clinical trial report, name the main author and ask for a manuscript, and the first draft took as long as writing one takes, at one extreme two or three days for a very straightforward manuscript. ^{22, 23} The compliance around manuscript writing, which exists to keep the process ethical, now makes it much longer: inviting the authors to take part, obtaining authorship agreements, setting up kickoff meetings, making sure every author has input, collecting all their comments and getting all the approvals. ²³ On that basis, one experienced writer allows about three months for the first draft, to be on the safe side, because putting the compliance steps in place and getting the approvals of everybody who has to approve take that long. ^{23, 24} As a contingency, publication planning tends to work in quarters, setting submission in, for example, the first quarter of a year rather than on a specific date, because a project can run quickly but more often meets unforeseen delays. ^{24, 25}

How much time to add to a project for unforeseen delays is a tricky question that depends on several variables. ^{26, 27} The first is the number of authors, since the more authors there are, the more unpredictable things can happen. ²⁷ The authors' culture is another, depending on where the authors come from, and even authors from the same country may differ, for example by belonging to different political parties. ²⁷ A third is how stringent the sponsor's timelines are: a launch publication that does not exist when the product reaches the market is serious trouble, and in one experienced writer's view a medical writer who misses that kind of deadline will not be engaged again. ^{27, 28} In one exceptional case, for the launch of a new product, the results arrived on the day the submission dossier went to the regulatory authority, whose fast review assured feedback within a month, and the team had one month to write an article for a top-tier journal, practically from scratch, with twenty authors. ^{28, 29, 24} Disagreements between authors about the manuscript's plan or content can arise at any time during its development; addressed early, they are likely to be defused and be less of an issue later, and a proactive plan builds in a contingency for the delay they may cause. ³⁰ One way to set the buffer is to look first at why the article is being published and how many authors it has, and to calculate it as a percentage from there. ²⁴

Agreeing the storyline

In the same lead author's experience, a perennial challenge in working with co-authors is agreeing on the key messages: the analysis itself can be problematic, but framing the messages to best meet the needs of the primary audience can generate many discussions. ²¹ There can also often be disagreement about who the primary audience is. ²¹ A good paper often spans several disciplines, and each member of such a diverse team usually has a viewpoint on the key messages and their rank of importance; an experimental pathologist will want the pathology data positioned centrally, whereas a toxicologist might want the general toxicology data to take centre stage. ²¹ It is essential that the key messages and their priorities are discussed as early as possible and agreed at the outline stage, certainly before the first draft begins. ²¹

One way to agree the contents is a storyboard built from scratch. ²¹ The team starts with a blank sheet of paper and brainstorms, usually ending with bits of paper pinned over the wall and spread across the floor; it then goes through the story and decides how the data or key message on each piece contributes to the manuscript, and anything superfluous to the main story is put into a back-up pile for later consideration. ²¹ One of the most challenging parts is keeping the story as clear and simple as possible, because team members often want to include a piece of data solely because the work was done. ³¹ In one extreme case, a potential author argued for including data because he had spent hours generating statistics and beautiful graphics, and it took a while to convince him that the data, however well presented, were not relevant to the paper being constructed. ³¹

A storyboard is best started as a rough sketch rather than from the details of the data, asking what the key points are and how they assemble into a logical order, and a deliberately controversial straw man gets the team discussing. ³¹ A good, functional storyboard may be nothing more than a sketch of the results section, so elaborate diagrams and detailed tables should wait until the message is agreed. ³¹ The team should be prepared to drop data sets that add nothing to the story or, better, to consider how they might contribute to the next manuscript. ³¹

The scientific decision process

A medical writer often sits where the perspectives of the authors and key opinion leaders, other researchers including statisticians, and the life-sciences company or other grantor overlap, with institutions, journals, professional societies and government bodies influencing each group. ³² To achieve fair balance, the writer needs to learn and own the potentially disparate perspectives and agendas of different authors, reconciling the distinct and often competing perspectives and interests of the participants, and diplomacy may be required to craft sentences that inform readers' practice yet are mutually agreeable to key opinion leaders, their institutions, sponsors, regulatory and other agencies, and professional and patient-advocacy societies. ³²

As proactively as possible, the writer needs to identify the philosophical "seams in teams" that might rend a writing project, such as a life-sciences company inviting a dyed-in-the-wool clinician to coauthor an observational study with a paucity of high-quality patient-level data. ³² In many cases the corresponding author is relied on to modulate, if not resolve, such conflicts, and the GPP3 panel of 2015 advocated that the authors of a paper proactively establish a process based on honest scientific debate to reconcile differences in their perspectives on, and inferences about, the study data. ³²

According to the GPP3 panel, the relationships between the sponsor, the authors, the medical writer and other supporting personnel should be delineated in formal correspondence, ideally before the kickoff meeting, and that correspondence or other formal, recorded interaction between the sponsor and the prospective authors should also delineate the protocol for reconciling differences of opinion among the members of the writing team. ³³ The process should be conducted in an objective, evidence-based manner; one approach is to default the decision to the corresponding author if the participants are at loggerheads, a contingency that should be spelled out clearly at the kickoff meeting or before drafting begins. ³³

Dividing the drafting

Collaborative documentation is increasingly becoming the norm, but teams collaborate in many different ways, and writers play very different roles depending on their team's collaboration style, which affects how they conceptualise, draft and revise collaborative documents. ³⁴

Three collaborative writing methods are layering, combining and stitching. ³⁵ In layering, the team meets to discuss the content and overall direction while one person, usually the team leader, writes the first draft, and the other members then weave their ideas into it, which allows a more continuous writing style. ³⁵ In combining, the team meets to discuss content and outlines major themes or sections, and each section is delegated to a member and returned to the leader, who combines them into one document, which is time-efficient and lets each writer use their strengths. ³⁵ Stitching is a highly structured and focused approach in which the team outlines each paragraph, including its topic sentence, each member is assigned a paragraph, the leader stitches them together and the team refines the result; it requires more meetings to plan specific content, but the time invested up front can save time later. ^{35, 36} The best process is the one that works for the team, and knowing the members' strengths, weaknesses and professional goals can help identify the most appropriate methods for every major phase of the work. ³⁷

Over one year, a team of four medical writers at the Duke Clinical Research Institute helped groups of multidisciplinary authors, among them clinicians, bioethicists, regulatory experts and patient advocates, produce twelve manuscripts for a theme issue of the journal Clinical Trials on ethical and regulatory issues in pragmatic clinical trials. ³⁸ Unlike projects in which authors are assigned topics to write independently, each group worked collaboratively over recurring web conferences and teleconferences and an intensive two-day in-person working meeting, at which the authors refined their ideas and presented draft summaries to the other groups for evaluation and feedback. ³⁸ Depending on each group's needs, the writers facilitated discussions, helped outline, draft and edit the manuscripts, provided reference materials and generally served in a supporting role, with project managers providing operational support and the issue's guest editors the leadership. ³⁸

One voice across several authors

Each author's style is their fingerprint: in a chapter written in turn by two or three authors, one editor of multi-author reference books can tell where authorship changes, even when the font is the same throughout, because the style abruptly changes. ³⁹

One of the authors of Good Publication Practice 2022 holds that authors and writers get so engrossed in the parts of a publication they are passionate about that they may forget to make other parts consistent throughout, so a document needs an outside voice: someone who oversees it, reads the whole thing and makes sure it is all consistent. ⁴⁰ When the global team wrote that document, the person responsible for its language consistency pointed out that six different words had been used to mean the same thing, which had sounded acceptable to authors used to moving between different contexts, and in that author's view the document could not have reached the quality it did without that person. ^{41, 40} Some of its reviewers and authors were very specific about the wording they wanted, and in the end, for consistency's sake, the team decided to thank them for their comments and keep the document consistent. ⁴² That can be a difficult conversation when people feel strongly about wording, and it comes down to compromising without affecting the consistency of the whole manuscript. ^{42, 43}

Problems in the team

Problems can develop in writing teams for several reasons. ⁴⁴ Leadership may be confused, with the member who agreed to be in charge not leading; one person should be tasked with taking charge, assigning roles, setting agendas and keeping the group moving. ⁴⁴ Members may disagree about how the authors will be listed, and teams have been known to dissolve in anger over it. ⁴⁴ A slacker may not be getting the job done, which is especially onerous if they hold a vital responsibility such as seeking funding or performing the statistical analysis, and the team then needs an intervention with a gentle but firm confrontation. ⁴⁴ Wordsmithing by two people is tedious and by more than two worse still, and wordsmithing is and should be a solitary activity, based on written suggestions from the others on the team. ⁴⁴ In a power play, someone exerts undue force, as a challenge to the leader or an attempted veto, such as refusing to let the paper be submitted with their name on it unless a sentence is omitted, and the whole team must then be involved in negotiating a satisfactory solution without caving in to power. ⁴⁴

In one commentator's experience, the most frequent practice among researchers is for the first author to send a manuscript to the co-authors, without an order of authors, with a vague request to say what they think; the troubles begin there, and an "atomic war" is triggered when the order in which the authors are listed has to be decided. ⁵

The same lead author deals firmly with collaborators who do not fulfil their obligations. ⁴⁵ Developing a manuscript quickly and efficiently requires good leadership, and once the storyline is agreed and the authors know their responsibilities, a firm hand is needed to drive the project and keep to the schedule. ⁴⁵ Because collaboration and networking are the lifeblood of good science, her decisions always leave her a way forward: she follows up a difficult decision with a phone call and then with an email confirming in writing what was agreed. ⁴⁵ Where people lose interest or do not deliver on their commitments, she escalates the issue, usually by email so that there is a written record, and states that if there is no response by a specific date, it will be assumed they no longer want to be part of the paper; that is the ultimate sanction, and no one really wants to use it. ⁴⁵

She also led a consortium of some forty scientists from academia, industry and the regulators, each of whom contributed to the consortium's work to some extent but not all to its paper, so authorship, acknowledgement and no part played had to be teased apart, on top of the approval-to-publish processes of forty different institutions. ⁴⁶ She nearly gave up on it, but determination paid off, and, as with any project, early discussion and agreement of the story and the authorship, and good project management, paved the way for a successful if drawn-out outcome. ⁴⁶

Closing the authors' review

Once a trial's results are available, the first thing prepared for any publication is an outline, which normally sets out the points to be made in the introduction, the methods, the results and the discussion; the authors revise it, and the first draft of the manuscript is prepared from the revised outline. ⁴⁷ The authors revise the first draft, which is sometimes ready as it is but most often needs a further cycle of revision, or more than one, until the authors have the draft they think final; that is the version they have to approve before it is submitted to a journal, or to a congress if it is an abstract, a poster or an oral presentation. ^{47, 48}

The people a writer drafts a manuscript for are the ones who will be named as its authors, and they will have strong opinions about what should be written in it. ⁴⁹ The people who review a writer's documents criticise them and write all over them in red pen or track changes, and sometimes they might be wrong. ^{50, 49} The writer then has to be able to tell them very diplomatically why the writer thinks they are mistaken, treating them as the authors of the document while being, at the same time, sometimes the person who knows how to write better than they do. ⁵⁰ In one experienced writer's view, such criticism comes most days of the week, and the writer has to see it as something positive, because the critics are authors and it is good that they are motivated, interested in what the writer is doing and helping. ⁵¹

Keeping the authors of a document focused and on track matters a great deal, because otherwise they tend to go too deep sometimes. ⁵² A messy process among the authors is acceptable, but without somebody able to guide them back onto the right path, they will never finish. ⁵³

Even in the most favourable case, with the writer involved from the study protocol onwards, an author group that already knows one another, and drafting begun as soon as the statistical analysis is ready, everyone arrives at the discussion and the conclusions with a different mind and wants to change a word, add a comma or alter something. ⁵⁴ What matters is a good timeline that everyone has been made aware of and is aligned with, and a comment period that is explicitly ended: this is the time for comments, then no more comments, this is the version everyone has agreed, and all that remains is to approve it for submission. ⁵⁵ Process-management tasks of that kind are sometimes the only way to survive a never-ending revision. ^{55, 26} A congress abstract is simpler because it has a submission deadline and in the end everybody understands it, but the overwhelming majority of journal articles have no such strict timing, so the writer has to set the timing for everyone. ²⁶