Work on a clinical research manuscript as its professional writer
A professional medical writer working on a manuscript that reports a clinical study for a peer-reviewed journal contributes to it under the authors' guidance, and the work answers to professional ethics, best-practice standards, reporting guidelines and the journal's instructions. It assumes particular skills, and it runs from starting the project in an organised way, through drafting with annotated sources and timely queries, to preventing the pitfalls that undermine a manuscript and working with authors and clients who make the job harder.
What the writer contributes and answers to
Reports of clinical investigational studies are among the most impactful articles in peer-reviewed journals, and prompt publication of clinical trial results is essential to discussing their implications for clinical practice and any potential improvement in patient outcomes. Clinical investigators, however, balance clinical, research and other duties and usually have little time to prepare manuscripts, and their junior colleagues often have even less time and less training in writing them. Involving professional medical writers can improve the quality of these manuscripts and shorten publication timelines, and the writer lays the groundwork for a submission-ready manuscript as a specialist nurse or physician assistant does for a physician treating patients.
Writers can contribute to various aspects of a manuscript's preparation, in collaboration with the lead investigators and authors and under their guidance. For an early-career writer, such a project can be a daunting challenge. One freelance writer has sometimes been asked only for a partial or complete first draft, has at other times supported a manuscript from its conception through various revisions to readiness for submission, and has occasionally revised other people's work for submission to a different journal. A full assignment might begin with meetings with the authors, the biostatistician and other team members to discuss the main objectives of the publication, the key data, figures and tables, the target journal, authorship and the timeline, working from the protocol and from the interim or final analysis as compiled in tabulated data, the clinical study report, a partial analysis or an oral or poster presentation. The writer might then research the literature and write, edit, reference and annotate a first draft or detailed outline, data-check and fact-check it, and query missing data and other issues; track versions, compile review comments, incorporate the authors' edits and query unclear comments while revising; format the draft to the journal's requirements and prepare it for submission; and, after editorial and peer review, revise in response to reviewers' comments when the decision is a conditional acceptance or an option to resubmit.
The work must reflect four kinds of guidance: professional ethics, such as those of AMWA, EMWA and ISMPP; standards for best practice, such as the ICMJE recommendations, Good Publication Practice and the Council of Science Editors' recommendations; the health research reporting guidelines of the EQUATOR Network, such as CONSORT for randomised trials, STROBE for observational studies, PRISMA for systematic reviews and SQUIRE for quality improvement studies; and the target journal's instructions for authors, covering its editorial policies, its guidance for particular article types and its manuscript preparation and submission requirements. Within that guidance, one experienced writer's main goal is a succinct, clear, well-organised and accurate draft that reports the study's results and the authors' interpretation while following the target journal's guidelines. In her view, high-quality, data-supported work maximises the chance that the manuscript is accepted and minimises the work required of others, such as authors, editors and other collaborators.
The writer is usually not an author, because the contribution does not meet all four ICMJE criteria: a substantial contribution to the conception or design of the work or to acquiring, analysing or interpreting the data; drafting it or revising it critically for important intellectual content; approving the final version for publication; and agreeing to be accountable for every aspect of it, so that questions of accuracy or integrity are investigated and resolved. Under the ICMJE standards, journal guidelines and other best practice, the manuscript must acknowledge the contributions of the professional writer and of any medical editor, together with the source of funding for their work.
The skills and style guidance the work assumes
Writing research manuscripts calls for a variety of skills and high-level competencies; it is a profession, not a hobby that can be casually picked up. The essential knowledge and skills fall into five groups: interpersonal skills (communication and tact, being a team player, attention to detail, organisation, problem-solving and creativity, time management, and logical and analytical thinking); medical writing knowledge (manuscript construction, medical terminology and concepts, data and statistics, literature research, journal requirements, annotation, the art of the query, and the AMA Manual of Style); professional ethics and best practices (knowing them and how they apply, understanding one's responsibilities, and making good decisions); software skills (word processing, creating and manipulating tables and graphs, online research and reference management); and writing and editing skills (grammar and usage, sentence structure, spelling, punctuation, and planning and outlining).
Mastering the craft of medical writing is key to completing a research manuscript project successfully. One experienced writer applies the AMA Manual of Style's guidance alongside the journal's own manuscript preparation instructions, and finds that doing so makes her work more consistent and clearer and helps her educate authors, clients and colleagues on best practices in medical writing.
Starting the project
When the writer synthesises information and data from various sources into cogent, accurate drafts for the authors to develop, the second principle of the AMWA code of ethics must stay at the forefront: medical communicators should apply objectivity, scientific accuracy and rigour, and fair balance while conveying pertinent information in all media. Examples of sources for each major section are the authors' text and notes, the outline, the protocol, the references provided and the writer's own research, and the study report for the introduction and discussion; the protocol, the statistical analysis plan, the study report and the authors' notes for the methods; and the clinical study report or other study report, the tables, listings and figures, slide and poster presentations, and spreadsheets of data, figures and tables for the results. Notes from authors can come from meetings, emails and phone calls.
One experienced writer recommends seven steps for starting a manuscript project efficiently. First, study and organise the materials, and keep them organised. Organise them into standardised electronic folders; as a freelancer usually not bound by a company's internal processes, she files every project in five, Background, Communications, Paperwork, References and Text, each labelled with a client and project code. Make sure of the project specifications, the team's roles and responsibilities, the format of the deliverable and the timeline, and with a new group confirm the lines of communication, such as who will answer queries and who will supply the PDFs of reference articles. Keep the emails and notes from kick-off and follow-up calls and meetings, so that a paper trail documents everything. Second, decide what else is needed and what to ask or research, keep notes on questions and issues, and send queries to a key contact by email when digging deeper in the material does not resolve them, keeping track of the queries and responses. Her first questions are typically what source materials are available, such as the protocol, study report and key references; what the target journal is; when the first deliverable is due; whether the client wants sources highlighted and the first draft annotated, and in what format; and which reference management software, if any, may be used.
Third, study the journal's manuscript preparation instructions, and note its requirements and stylistic preferences: word counts for the abstract and main text, limits on tables, figures and references, the types of headings, and data format such as P values and significant digits. Find two or three studies in the target journal similar to the one being written, to help structure and format it, and a few recent papers by the lead authors for a general idea of their writing style. Fourth, set up the Word document, using the client's template if one is required and otherwise structuring it to comply with the journal's instructions; modify the heading styles to outline and navigate the draft, include a statement acknowledging the contribution as writer or editor and the source of funding, and work efficiently with the Quick Access toolbar, keyboard shortcuts, the Navigation Pane and the split-screen view.
Fifth, set up a reference management library for the project, such as EndNote, import citations from PubMed, other databases and journal websites, and if needed correct the EndNote style to match the journal's current format. Sixth, name reference PDFs in an easy, consistent format so that the right one is easy to find while drafting; her preferred format is the first author's last name, journal abbreviation and year, as in "Smith et al J Clin Oncol 2023", and a file should not be named by its title, which is too long and not how papers are cited, though a short phrase summarising the title can be added, as in "Smith et al J Clin Oncol 2023 [phase 3 drugX melanoma]". She no longer prints reference articles and other key sources, and works from the PDFs side by side with the draft, highlighting and annotating as she goes. Seventh, use a simple file-naming system that supports version control and so minimises confusion during reviews, such as "smith phase2 ms d1.0", with reviewers adding their initials to the file name or the writer renaming it on receipt. Where a lead author or client renames files to their own system, she sticks with theirs and keeps detailed notes of versions and author responses.
Annotation, queries and word counts while drafting
While researching and writing the first draft of a detailed outline or manuscript, one experienced writer highlights the references and annotates the corresponding PDFs. Examples of annotation formats range in detail from the first author, journal, year and page, through adding the column and section, to adding the column and the paragraph or line number. She puts notes and queries about potential issues, such as missing or unclear methods or inconsistent use of terms, in comment boxes or in brackets in the text, and emails small batches of the queries that need prompt attention because they affect how she proceeds, holding that issues are best resolved sooner rather than later and that a draft should not go out peppered with queries that should already have been resolved. A query in the text should be concise and polite, clearly marked to distinguish it from notes and annotations, addressed by name if it is meant for one person, and offer specific suggestions wherever possible; a query by email should be succinct, organised and polite, use bulleted lists, identify the relevant section of the manuscript, and be easy to read and answer.
Helping the authors comply with word count requirements, which for some journals are stingy, is part of the writer's job, and it can be hard during revision. The same writer tracks the word count throughout and updates both the main-text and the abstract counts before sending any draft for review; when the authors exceed the limit, she suggests edits in tracked changes that keep the meaning in fewer words, and sometimes suggests moving sections to an online supplement.
Common pitfalls and their prevention
Five common pitfalls each have a prevention: accidentally plagiarising published information or repurposing unpublished content, prevented by paraphrasing and citing; perpetuating inaccurate data and facts, prevented by fact-checking and research; inserting erroneous data, prevented by copying data carefully and performing quality control checks; creating a disorganised, inconsistent manuscript structure, prevented by checking for consistency and keeping parallel structure; and introducing typos, spelling mistakes and poor grammar, prevented by proofreading. Most of these errors are unintentional and caused by taking shortcuts. Where medical editors are on the team they will also check for these problems, but they might not be involved until later, and the writer should give them and the authors a well-written, organised draft to work on.
Text should not be copied from protocols, clinical study reports and other unpublished documents, whose style is often unsuitable for a journal article because it may be passive, formulaic and verbose; it is better to paraphrase, pay attention to active and passive voice, and avoid archaic terms such as "subject" and "Caucasian". One experienced writer is also cautious about copying whole tables or parts of them between files, because disruptive formatting codes might carry over into the manuscript, and in 2023 she would not use any content generated by an artificial intelligence program such as ChatGPT.
Another common pitfall is incorporating data and information cited in other documents, such as protocols, clinical study reports and published articles, without fact-checking the accuracy of each citation. The same writer checks that the cited reference does provide the information, often with the PDF search field to find specific numbers or terms, and where the cited information is more than one or two years old, depending on the field's pace of research, searches the literature for more recently published sources; she holds this especially important in a rapidly advancing field such as oncology, where, for example, the American Cancer Society publishes new statistics every year. Even when the project specifications do not require it, she highlights references and annotates the detailed outline or first draft to keep a record of the sources of any information and data included. In her experience, this step does not take long, and it saves time and trouble during review and revision when authors and other project participants raise questions about data accuracy, conflicting information or other issues.
Compiling data into tables and figures is among the most tedious tasks of the project, and keeping track of and accurately copying numbers from large tables prepared for clinical study reports, tables, listings and figures, and other study reports is hard. To avoid losing track while copying, one experienced writer places the documents next to each other on a large screen and enlarges both; copies or retypes, and where necessary rounds, small batches of numbers at a time; highlights the copied data in the source document to mark her place; and every two or three rows backtracks and double-checks the values to correct any typos. Before any rounding, it is important to confirm with the authors how many significant digits they want throughout the manuscript.
To create a well-organised, easy-to-read manuscript, the writer must ensure that terms, abbreviations and data are used consistently across the abstract, the main text, the tables, the figures and the online material; for example, the definition of an outcome measure in the methods and results should match the one in a table. Numerical inconsistencies might especially occur where numbers are rounded in one place, such as the results text, and not in another, such as a table, figure or abstract. One experienced writer uses Word's split-screen view to help verify that numerical data are reported the same way across sections. Subheadings, paragraphs and sentences that discuss similar information should also have parallel structure; for example, the presentation of information in the methods should match the sequence and content of the data the results discuss. Although some of these tactics may appear subtle, together they improve the manuscript's clarity and maintain the reader's interest.
Challenging authors and clients
Some authors and clients are easy to collaborate with; others might pose challenges, being for example unresponsive, set in their ways, condescending, overly demanding or inexperienced. Whatever the case, the authors have the final say over, and responsibility for, the content of their manuscript, and the writer can offer suggestions and education, but all final decisions are theirs. Patience and tact are essential with challenging individuals. For example, when one experienced writer must answer an irritating email, she drafts a reply and steps away from it for at least several hours before editing it, usually to tone it down, and sending it; sometimes discussing the matter with a trusted colleague before communicating further with the difficult person might help. She also keeps every project email organised, continuing the paper trail kept from the start of the project, so that she can verify earlier responses, which is especially helpful when someone asks for one thing one week and something completely different the next, ignores several polite emails asking for clarification or further instructions, or demands a draft earlier than agreed.
Other tactics are to be clear, concise and tactful in every form of communication, whether email, in-draft queries or voicemail; to suggest concrete solutions for issues in the authors' writing, such as rewording an unclear passage into what it seems to mean and asking the authors whether the edited version is correct, rather than only saying it is unclear; and to use the AMA Manual of Style, the journal's author guidelines and examples from articles in the same or more prestigious journals to educate about formatting and style decisions. For example, authors sometimes spend their review time changing "ie" and "eg" to "i.e." and "e.g." without understanding that the writer used the unpunctuated forms on purpose to follow the journal's style, even when the first page notes that the manuscript is formatted for that journal; in such cases the same writer declines the changes and explains her rationale, citing the appropriate style manual or manuscript preparation instructions. Another tactic is to try other ways of communicating: someone who does not answer email might be reached by a phone call, or by first speaking with an administrative assistant or another member of the project team, and an online meeting with a shared screen, editing live, might work well for authors who never find the time to review drafts and send their comments in tracked changes.