In academia and medical research, the majority of my writing involved research grants and publication manuscripts. Success in one drove success in the other, a relationship that some of us saw as a “vicious cycle” and others as an “upward spiral.” More planning efforts went toward the research than the publication. Of course the main objective was to obtain and communicate good results from well-designed investigations, but equally important were tenure, professional advancement and funding to keep the lab operating.
In most research “communities” the major players are well known to each other. Each has a certain perception of the others. I’m not crazy about the term “branding,” but that is what it comes down to; branding of both labs and researchers that is largely determined by funding and publications. In the world of pharma, the identities and characteristics of most products are established well before they are licensed and marketed. Much of this is achieved through publication of the clinical trial results supporting the product’s registration and licensing by regulatory authorities (e.g. the FDA in the US or the EMA in Europe). Publication of post-marketing trials continues this “branding” process.
A good publications plan assures that the market is ready for the product at the same time that the product is ready for market. So what is it all about? The primary objective of a publication plan is to show how clinical trial results can be communicated at congresses and in peer-reviewed publications in a timely manner, i.e., within a year or two of study completion. As a rule, there should be original, primary research publication reporting on each trial and at least one congress presentation. Why is this important? Investigators and study sponsors must post their clinical trials on publicly accessible internet sites, such as www.clinicaltrials.gov, before enrolment begins. The absence of subsequent publications thus becomes noticeable. Additionally, publications are just about the only chance for a peer-reviewed, validated discussion on the significance of trial results. So what do you base your plan on? Start with a list of ongoing and planned trials and a folder full of protocols and clinical trial summaries. Given the info in the protocols and summaries, submission deadlines for relevant congresses can be matched to trials as data become available, and timelines can be generated for the primary publications of the trial results.
Choosing journals and identifying authors ought to be part of your plan too, but that’s beyond the scope of this short blog piece (more about that another time). Additional, secondary publications including subgroup analyses, topics for pooled data analyses, post-hoc analyses, systematic reviews and the resources required for them, such as statistical analyses, can also be proposed as well as publications for additional audiences with re-analysis of data. However, duplicate publication of results must be avoided. How is all this done? Many pharma companies have organized publication steering committees to help ensure appropriate, efficient, and complete communication of results. Formalized publication procedures to guide manuscript development and submission are also becoming the rule rather than the exception. Planning is thus a team effort, including stakeholders from medical affairs, marketing, regulatory affairs, pharmacovigilance, medical writing, and others. Protocols, study report summaries, product positioning strategies, and competitive benchmarks all contribute to the interpretation of data.
Essentially, these determine what can legitimately be said about the trial results within the specific medical, clinical and regulatory contexts. Steering committee activities concerned with a specific publication plan may be organized by internal publication managers with or without the assistance of project managers, medico-marketing consultants, and writers from external agencies. That’s just some of my take on pub planning, and it’s just the “tip of the iceberg” so to speak, with more being unsaid than said. It was hard to pick a point at which to stop the blog. Want more info? Try the “The Publication Plan” discussion group at LinkedIn.com and check out the International Publication Planning Association (TIPPA) website at http://www.publicationplanningassociation.org/. The International Society for Medical Publication Professionals (ISMPP) at http://www.ismpp.org/ also has pub planning resources.
To get some ideas on how pub planning relates to pub writing, take a look at their guidelines in Good Publication Practice (GPP and GPP2) on their website and published in the British Medical Journal (BMJ) (2009;339:b4330). Well, cheers and bye for now. If there are other aspects of pub planning you’d like me to give my views on, just ask in a comment.