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What does your job involve?
The role of the Global Publications Manager in AstraZeneca is to ensure full publication of data from our clinical trials, working closely with investigators and authors to facilitate the publication process. To achieve this, we lead cross-functional teams in-house, and also work with medical communication agencies who provide writing or editorial support to the authors. On a more day-to-day basis, we could be involved in the development of anything from an abstract to a technical product review, and working with a whole range of specialist colleagues including preclinical scientists, pharmacokineticists, statisticians and physicians.
How did you get to where you are?
I completed a Pharmacy degree at Manchester, and followed this with a couple of years in retail. When I realised that wasn’t going to keep my interest, I went back to University to undertake a PhD. I then joined Sanofi Winthrop as a Clinical Research Associate, and spent a couple of years becoming very familiar with UK motorways. In 1994, I joined Zeneca, as we were then called, working in the Clinical Pharmacology Unit, developing and reporting first-into-man studies, and then spent a few years in various roles supporting phase II and phase III trial programmes. With such a strong Clinical background, it seemed a natural progression for me to move into Publications 3 years later. It’s been a happy 7 years, initially supporting our Lung Cancer programme, and the last four years in Breast Cancer.
What do you enjoy most and least about your job and/or publication planning?
I really enjoy the interactions with physicians, getting real insights to their current practice and future directions. I also enjoy working with our other Publications Managers; I’ve known many of them for years, and we are a strong, experienced group.
I can’t say I really enjoy the more business-related activities such as forecasting resource and budget.
What are your favourite online resources?
We are very fortunate with the resources available to us in AstraZeneca. Most importantly, we have e-access to all the major publishers and journals, but we also have access to the Peerview applications: Journal Selector and Conference Authority. In terms of keeping up-to-speed on ethical and political issues etc, we have a very strong Publications Skills Group, with a number of Publication Managers having specific skills responsibilities to train or keep the rest of the group abreast of the ‘external environment’.
What are the most important issues in publication planning – past 5 years, present, future?
In the last few years, the acceptance that (with full disclosure) professional writers play a valued, and sometimes essential, role in the delivery of industry-sponsored communications has been a real step forward. There is still some scepticism with regard to the industry-funding of Medical Writers, but hopefully the ever-increasing transparency of the role of the pharmaceutical industry will continue to allay these concerns.
Currently, we are feeling the squeeze opposite the shortening timelines in place for posting results on our Clinical Trial Website. I believe that delivery of data in a credible scientific journal, following appropriate peer-review, is still the ideal scenario as opposed to posting of raw data without interpretation or discussion. Achieving this, however, is becoming increasingly difficult.
With regards to the future, I think we are yet to see the full impact of online publication and e-journals, and indeed, Open Access.
What are the challenges in deciding authorship of papers reporting large, multicentre studies with many investigators?
Great question, this is a really difficult area – it is so important for authors to take ownership and public responsibility for the content of the paper. We adhere to ICMJE guidance, but there can still be discussion with respect to fulfilment of the three criteria. For large, multi-centre studies, Steering or Writing Committees should be formed at an early stage, and it would be their responsibility to take authorship or make the appropriate decisions.
Have publication planners got the balance right between ethics and the commercial needs of the pharma industry? Do journal Editors have the right balance between ethics, needs of their readers and the commercial needs of their journal?
At AZ, we run an ethical Publication Policy, but all publication planners will know that their outputs will be used in a commercial manner, be it on a global basis or within local Markets by reps. As long as pharma publication activities are transparent to all, ethics and commercialism can co-exist within the same environment. However, there can be no trade-off - if ethics and commercial needs come into conflict, then ethics must always win.
In my experience, most journals have a fairly distinct separation between their editorial teams and those looking after their commercial interests. This works well, but again, ethics must always take precedence in times of conflict or uncertainty.
Does the future lie with online journals or will print journals continue to dominate for the forseeable future?
I am a little surprised that online operations don’t dominate yet; as an industry, we seem to be generally slower in moving to the e-world. In the foreseeable future, I think we’ll see online continue to grow at its current rate – it will be a long time before print copies disappear.
What changes in publication planning practice and journal policies would help to achieve timely and high quality publications?
I think it is already happening – the pharmaceutical industry and journals/publishers are starting to build good working relationships. We have been able to cut lead-times for example, for publication of some pivotal clinical trial manuscripts – to the benefit of both physicians and patients. We have had some very successful interactions in recent years, and I can only see this increasing.
How will posting of clinical trial results on registries affect journal publications?
Well, the timelines involved have certainly made manuscript delivery more interesting! The issue is the posting of data before full publication of the primary paper – AstraZeneca now commit to posting within 12 months of last subject, last visit for licensed products. Thankfully, most journals appear to be recognising the challenge and, in welcoming the openness this offers, they have addressed their prior publication rules to allow for it.
Is 'marketing' a dirty word in relation to publication planning?
On the contrary. The key to effective marketing is the identification and clear communication of the key benefits and risks of the products. In that sense, the goals of all those involved – be it marketing, publication planning, or indeed anyone whose role is to make a meaningful difference to patient health – are aligned rather than in conflict.
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Feedback: Do you have any comments about this article? Contact the Publisher, Peter Llewellyn.
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