Publication strategy

A publication strategy connects the evidence available with the audiences who need it, the forms in which it will be communicated and the time it should reach them. It coordinates a programme of publications across studies and the product lifecycle, with responsibilities, delivery milestones and evaluation planned together.

Purpose, scope and ownership

Publication strategy maps what, when and how research will be published, including article and journal types selected for the target audience; the research environment strongly influences the strategy. ¹ A publication plan structures dissemination of basic research and clinical data about a new product, a new use for an existing product or a new approach to disease management. ^{2, 3} It may schedule publications and presentations from one study or coordinate an entire development programme, from early phase 1 through large multicentre phase 3 studies. ^{4, 5, 6, 2}

Academic publishing primarily advances scientific and medical knowledge and is usually less regulated internally than commercial publishing, leaving academic researchers responsible for their own publication efforts. ⁷ Company plans may be developed in-house by pharmaceutical, biotechnology or device organisations or outsourced to medical communications or publication companies. ²

A publication steering committee and scientific publication team develop the plan with the publication lead and writers, aligning it with drug development and the product lifecycle through needs assessments and internal and external gap analyses. ⁸ Publications can also respond to medical queries received by medical information departments. ⁸ In pharmaceutical companies, the steering committee and finance department prepare publication-planning cost estimates. ⁸

In a survey emailed in August 2007, 40 of 61 respondents (66%) said their companies developed publication-planning strategies and 13 (21%) said sometimes; among pharmaceutical-company respondents, the figures were 75% and 19%. ^{9, 10, 11} Device and biotechnology companies appeared somewhat less likely than pharmaceutical and medical communications companies to plan formally, though numbers were small; the two pharmaceutical companies without formal planning were reported as based in India and Japan. ¹¹

Needs, data and timing

A needs assessment should establish each audience's current knowledge and information needs, including those of physicians, nurses and pharmacists, then determine when and in what format it should receive information. ² Planning aims to deliver the right information to the right audience at the right time. ^{12, 13} Four aspects are data availability, authorship, audiences and publication type, and publication steps. ¹⁴ A 2021 planning view treated peer-reviewed journal articles as the most prestigious communication vehicle because of reviewer endorsement, journal standing and scientific and ethical character. ¹²

Planning should begin as early as possible in the product lifecycle so gaps can be anticipated and addressed, rather than waiting until late development or having no plan. ^{15, 13} For example, recognising missing health-economic-outcomes data early can prompt proposed trials while the team can still generate them. ¹⁶ Plans can encompass preclinical, clinical, economic, epidemiological and real-world-evidence studies. ¹³

The data inventory starts with ongoing, planned and completed clinical studies and their key dates: last patient visit, statistical-report availability, and clinical study report preparation and finalisation. ¹⁴ Study designs and expected outcomes inform potential publication titles or brief descriptions, with the process repeated for local health-economic and epidemiological studies. ¹⁷ Addressing planning considerations stepwise helps secure appropriate data, audiences and timing, giving the time and effort invested in trials a published outcome. ¹³

Multicentre studies may support several publications about different findings or country-specific data; each should appear promptly, especially for phase 3 research, without jeopardising the others. ¹⁸ An early, well-chosen team can use expected data and delivery dates to identify meetings with abstract deadlines near anticipated database lock and assess how meeting dates affect journal submissions. ¹⁸ Regular meetings should update the plan as study dates change. ¹⁸

Commercial lifecycle objectives

A 2015 commercial-development framework held that publication strategy should be integrated with drug development and align personal and commercial interests, while commercial interests should influence timing rather than whether research is published. ¹⁹ Premature disclosure can sacrifice a competitive advantage, while an early publication may create anticipation; a high-quality paper in a reputable journal by an accepted opinion leader near launch was viewed as a marketing asset. ^{19, 20}

That framework set three aims. ²¹

1. Create anticipation before approval and launch. Examples include nonclinical efficacy and safety, a favourable pharmacokinetic profile such as once-daily dosing or no food effect, proof of concept in volunteers or patients, and positive dose finding.
2. Reinforce the launch campaign. Make good-quality publications available at launch, ideally with an editorial mention in a high-quality journal, describing efficacy, safety and added treatment value; papers on drug interactions, renal impairment or synergistic co-medication effects might encourage prescribing.
3. Maintain lifecycle momentum. Publish clinical experience that may reinforce use or persuade new prescribers, and reviews showing the treatment's potential addition to existing therapy.

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Scientifically interesting work without direct programme benefit, such as an investigator's report on recruitment difficulties, still needs guidance on timing to avoid premature sensitive disclosures. ²²

The relationship between science and marketing has been contested: in 2010, publication planners at a professional meeting reported a clear separation of the functions in their companies. ²³ Planning without integrity has been criticised as ghost management of scientific research for marketing purposes. ²

Delivery before public results posting

In 2008–2011, fixed US results-posting deadlines prompted sponsors to settle what, where and when to publish and who would author papers earlier in development, with accelerated manuscript preparation sometimes preceding completion of the clinical study report. ^{24, 25, 23} Sponsors preferred journal publication first to provide clinical context, reduce public misinterpretation and avoid problems from releasing unreviewed data; company procedures could prescribe the compliance sequence. ²³ Accelerated timelines left less time for analysis, interpretation and discussion. ^{24, 25}

Audiences, messages and communication formats

Audience planning starts with a main target and considers other potential readers: thought leaders, investigators, specialists and hospital doctors, primary-care physicians, epidemiologists, health economists, researchers and patients. ^{26, 27, 28} Open access means anyone may in principle read the publication. ²⁷ Topics should be tailored to audience interests and can include background, unmet need, mechanism of action, efficacy and safety, quality of life and cost benefits. ^{26, 27}

Publication formats include congress abstracts, abstracts for primary manuscripts or reviews, primary manuscripts, supplements, letters, editorials, short communications and other secondary manuscripts, including books. ^{27, 29}

A 2016 action plan for writers acting as communication specialists comprised three steps. ³⁰

1. Create a client roadmap.
2. Study journal options and align publication goals with them.
3. Offer improvements to messaging, tools and channels, and content: identify ancillary audiences, journals beyond impact factor, messages for new audiences and interactivity; consider print, online and spoken formats; propose bite-size, shareable content, ways to increase exposure, and formats for different audiences.

^{30, 31}

A roadmap can focus on a specific research set and align the client's communication goals with a journal; the resulting services place the writer in a consultant role. ^{31, 32} A manuscript can be repositioned as a newsletter, social-media content or a webinar. ³²

Evaluation and changing demands

Publication impact should be evaluated by asking whether target audiences read and understood the work, rather than treating publication as the end of the process. ¹⁶ Sources of feedback include independent websites, congress news, field-team feedback, social media, syndicated research, online forums and market-research insights. ¹⁶

Five areas were identified in January 2021 as growing opportunities for publication planning. ^{16, 33, 34, 35, 36}

1. Technology companies entering healthcare, including apps developed by Apple and Amazon, whose research would most likely need peer-reviewed publication.
2. Cell and gene therapies, with improved patient outcomes and high costs.
3. Genomic identification of variants or mutations associated with better treatment response.
4. Real-world-evidence research.
5. Health-economic outcomes.

^{33, 34, 35, 36}

By 2023, publication work encompassed phase 1–4 trials, real-world data, health economics and outcomes, biomarkers and translational studies, and preclinical research; teams could involve academia, sponsors, contract research organisations, alliance partners and patients. ³⁷ Wider audiences included investors, funders, payers, patients and families as well as clinicians and researchers, and one publication often required several deliverables with shorter timelines and more complex review and approval. ³⁷

Orphan-drug programmes bring four particular planning considerations. ³⁸

1. Small trial programmes provide fewer data-publication opportunities, so researchers may consider publishing clinical data sparingly.
2. Disease awareness may need review papers alongside data reports.
3. Few specialist journals and general journals' reluctance to publish rare-disease articles can complicate venue selection.
4. Author and expert-reviewer pools are small.

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