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BASICS << Right message, right audience, right time – phasing publications
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Right message, right audience, right time – phasing publications
Published 2 October 2008, written by Julia Donnelly
The planning, execution and completion of clinical trials are time-consuming and resource-expensive, therefore the communication of the data they generate and the messages they support needs careful consideration and planning. Scientific publications, especially in well-respected peer-reviewed medical journals, not only offer the most credible communication vehicle for such data, but are also essential for supporting key messages and claims in other literature.
Defining the right message, right audience and right time forms the basis of strategic publication planning and these will often evolve in parallel with drug development. During early development, the right messages will predominantly encompass scene-setting and awareness, aimed specifically at key thought leaders and investigators who will be essential for conducting the early clinical trials. Data demonstrating the mechanism of action, pharmacology and preclinical results can be published to generate noise and create awareness. In addition, review articles comparing the new entity with existing treatments or interventions will provide a useful context. As development progresses, then a wider clinical audience will be required to recruit and conduct the growing number of larger phase II and III trials. This audience will want information on the efficacy and safety profiles of the product. At this time, early clinical trials, such as volunteer and dose-finding studies should be communicated. In addition to publishing as full manuscripts, these data will provide useful opportunities at major congresses to increase awareness of the product and evaluate the reception of such data by meeting delegates. At the time of launch, the target audience will include the ultimate prescribers and payors, who will be specifically interested in how the product differs from the competition and the cost implications. Publication of the major phase III results will be essential to support the launch of the product. The major results will be published as the primary publication, but greater detail on specific findings or sub-populations can be usefully delivered as secondary publications or to secondary audiences, such as health professionals in other specialities than the primary audience. Publications presenting cost and outcome data will also be useful, if available and will help answer many of the prescriber questions.
At each of these stages, publications can be used to deliver the important messages – although, apart from awareness and scene-setting, these will depend on data availability. The right target audiences can be reached by a careful selection of journal or meeting. The right timing, however, is the most difficult part to achieve, as it depends on data availability, busy company, external and journal reviewers and journal lead times. Bad publication practice in the past saw delays in data release to coincide with important development events and both over- and under-reporting of results. However, with the advent of protocol registration and the posting of clinical trial results within a fixed time of last patient-last visit, submission, if not acceptance of the primary manuscript may be desirable before results posting in the public domain. Some publication phasing will still be possible by carefully considering journal lead times, and by using the quicker on-line access journals. Presentation of key data at meetings will still be a useful tool in publication phasing as will the development of worthwhile secondary publications.
Once the strategic elements have been agreed upon, the proposed tactical delivery of your publications can be plotted in the publication plan and you can be satisfied with your ‘perfect plan’. However, irrespective of whether your ultimate plan is a simple word document or spreadsheet, or a sophisticated specialised publication planning repository, delivery of the planned publications is the most challenging part of the publication planning process. Data availability, matching resource with ever moving timelines, conflicting reviewer commitments and journal timelines all confound to disrupt your carefully constructed plan. As a publication manager, perhaps the best you can strive for is an accurate overview of current status and good relationships with a raft of writers, internal colleagues and external authors (perhaps even a journal editor) – and of course excellent powers of persuasion!!
Strategic publication planning is always a difficult balance between the idealistic and realistic. In addition, new initiatives and guidelines are already impacting upon publication phasing and new ways of delivering ethical scientific publications are already in practice. Timing will always be the major challenge, but should ultimately not be allowed to jeopardise publication quality or ethical process.
About the author:
Julia Donnelly (E: Julia@juliadonnelly-solutions.com) is an out-contracted publication manager, working directly with pharmaceutical clients to deliver a series of publication plans. With 20 years experience within the pharmaceutical and communication industries, Julia has developed over 50 publication plans and delivers training at EMWA in publication planning and strategy.
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Feedback: Do you have any comments about this article? Contact the Editor, Mary Greenacre.
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