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    ONE DAY WORKSHOP - 10 JUNE 2008 - LONDON

    Successful publication planning – strategy, ethics and rules of engagement

    An overview report written by Mary Greenacre, Editor of The Publication Plan

    This informative and lively event, featuring characters as diverse as the Spice Girls and Goldilocks and the Three Bears, was ably led by Liz Wager (Publications Consultant, Sideview) and Rosie Stather (Editorial Director, Adis Journals).

    Liz began the day with an overview of the key considerations for publication planners, outlining the features of a good publication: right message, right audience, right time, and, importantly, respected by its readers. Liz went on to highlight the components of a strategic publication plan:

  • What (number of publications): need to achieve wide dissemination of trial results to different audiences, avoiding 'salami slicing'
  • Why (messages): ideally one message per paper
  • How (publication types): abstract, primary paper, secondary paper, short report, editorial etc
  • When timing of publications
  • Who target audiences
  • Where which journals and conferences?

    The 'soft skills' needed by a publication planner must not be underestimated. Publication planning and delivery involve a large team of people, each with different needs that are not always compatible – a minefield to be negotiated by the publication planner. Good communication is needed to get agreement on a strategy ('tell me what you want, what you really, really want'!).

    The day had a strong focus on publication ethics, an indication of the progress made in this area during the past few years. Clinical trial registries started in the 1980s, but received a major push from the ICMJE in 2004 with the decision that member journals would not publish papers reporting unregistered trials. The objectives of registries are to reduce non-publication of negative findings and redundant publications, prevent selective publication of only positive results and identify related publications. Register entries must be made before patients are recruited, and should contain the study design, the WHO minimum dataset and a description of statistical methods.

    The recent FDA Amendment Act (FDAAA) further requires that results of phase II-IV trials of drugs to be submitted to the FDA are posted onto www.clinicaltrials.gov within 12 months of the end of the trial. This will be phased in from September 2008, with an increasing amount of information required. The ruling has presented journal Editors with a quandary about whether such postings will qualify as prior publication of results – an issue to be discussed by the ICMJE this month (June 2008).

    Rosie Stather went on to discuss a number of authorship issues. She outlined the ICMJE's criteria for authorship (www.icmje.org), highlighting issues such as guest authorship (e.g. including a department head who made little contribution to the paper), ghost authorship (e.g. a pharmaceutical company employee who was substantially involved in preparing the paper but was not listed as an author), statisticians as authors and acknowledgement of medical writers. Most journals now ask authors to declare conflicts of interest and funding sources, but vary in their exact requirements. Some journals now do not accept review or commentary-style articles which are funded by industry or where the author has significant conflict of interest. Although many potential conflicts of interest exist, most journals focus on financial conflicts.

    Choosing the right journals is an important part of publication planning, and key criteria include: scope and format, types of articles, current topics, rejection rate, publication timelines, readership, indexing, author preferences, geography, reputation, impact factor, contacts and cost. Liz Wager described the Goldilocks and the Three Bears strategy for journal selection: the Daddy Bear strategy is over-ambitious, leading to rejection and delays, the Baby Bear strategy is over-cautious, leading to lack of prestige, low impact and unhappy authors, whilst the Mummy Bear strategy achieves a balance that is just right! Liz went on to describe some of the differences between open access journals and traditional journals:

    Open access

  • Author retains copyright
  • Articles can be distributed and copied if the source is acknowledged
  • Publisher charges an author fee
  • Free access to all

    Traditional

  • Copyright lies with journal
  • Permission required to copy or distribute
  • Publisher charges for reprints
  • Subscription based

    As well as the full open access journals such as PLoS, there are also optional open access journals where individual articles are freely available if the author pays a fee. Other journals offer delayed open access once an article reaches a certain age.

    Advantages of open access journals lie mainly with their wide access and ability to re-use articles without a copyright fee, but they can be expensive, have less of a reputation than traditional journals or may not have an impact factor (often simply because they are new), and are only available on-line.

    Rosie Stather concluded the day with a presentation on dealing with journals and editors. She recommended an initial approach to the journal to assess the general suitability of the article, perhaps with an abstract or outline, together with information on the authors and likely timelines. Editors are looking for innovation (e.g. a new drug, population or topic), credibility (big names or institutions) and relevance (important to the clinical practice of their readership). Common reasons for rejection include:

  • Unrealistic journal
  • Paper reports nothing new
  • Overlap with previous papers (including 'salami slicing' of trial results)
  • Not clinically relevant
  • Flawed design
  • Peer review comments not adequately addressed
  • Paper has been rejected before, but problems were not addressed before resubmission
  • Fraud (e.g. plagiarism, sometimes a particular problem with authors who are not writing in their first language) Rosie concluded with advice to follow the journal's requirements in terms of instructions to authors, journal policies and documentation, to stick to deadlines and to make clear from start any involvement of agencies or medical writers. Finally, if rejected, try to take on board any advice from the journal or peer reviewers before submitting elsewhere.

    To summarise, this is an interesting time for publication planners. The FDAAA is likely to have a considerable impact and clinical trial registers have already started to improve transparency of trial reporting. However, the components of a good publication and a good plan remain the same – good data, well written and thought out, clinically relevant, a clear message, delivered to the right people at the right time and respected by readers.

    To make sure you're included in announcements about future events just email Peter Llewellyn, if you haven't already done so, to register your interest.

  • SPONSORED BY:

    Wolters Kluwer Health
    Wolters Kluwer Health

    LED BY:

    Liz Wager, Publications Consultant, Sideview and Rosie Stather, Editorial Director, Adis Journals

    Liz Wager worked as an Editor at Blackwell Scientific before joining the pharmaceutical industry, most recently working as Head of International Medical Publications at GlaxoSmithKline. She now manages her own company, Sideview. Liz is the secretary of COPE (Committee on Publication Ethics) and is a member of both the BMJ’s Ethics Committee and the WHO Advisory Group on trial registration. Liz's publications, presentations and consultancy work have gained her recognition as one of the world's leading experts on medical publishing and she has run courses on five continents.

    Rosie Stather is Editor of Drug Safety and Editorial Director of the Adis Journals group, managing 12 Editors and 17 biomedical journals. Prior to her 15 years at Wolters Kluwer Health, Rosie worked for a medical communications agency in the UK and conducted research at the University of Reading and the University of Cambridge. Rosie has an MA with Honours in Natural Sciences from the University of Cambridge.

    Companies
    attending
    included:

    Axon Communications
    BioMed Central
    Catalent Pharma Solutions
    Chameleon Communications
    CHOICE PHARMA
    Discovery London
    Envision Pharma
    excellaspro
    Future Science Group
    GeoMed
    HealthCare 21 Communications
    Huntsworth Health
    Jane Fraser Associates
    Medical Education Partnership
    Medical Writing
    Ogilvy 4D
    Ogilvy Healthworld Medical Education
    PharmaCodes Medical Communications
    PPSI
    PraeMedica
    Publicis Healthcare Group
    Scope Medical
    Solaris Health
    Strategic Consultants International
    Wiley-Blackwell
    WordMedica Communications
    Zaicom MMC


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