Another blog entry on pub plans? OK, It seemed like a good idea when I first thought of it because pub plans are important and many medical writers get involved in writing them. They are important because phase 2 through phase 4 industry-sponsored, academic and publicly funded drug and medical-device trials must be posted online. Many high-impact journals require that to be considered for publication, trials be posted before subject enrolment begins. Do a search at www.clinicaltrials.gov if you want to see what’s going on. The postings are summaries of clinical trial protocols giving the rationale, objectives, description, sponsor, and chief investigators.
Results of trials of FDA-approved drugs must also be posted within 12 months after trial completion and, once the FDA approves or issues an approvable or not approvable letter, results of completed trials must be posted within 30 days. ClinicalTrials.gov has a Results Database that includes subject disposition, demographics, outcomes, statistics and safety data as well as links to any journal publications. So there you have it. Publication is really the final step in conducting a clinical trial. Publication is essentially the only way to disseminate an interpretation of study results, as that is not included in the internet postings. Publication has thus become even more imporatant now that clinical trials and their results must be posted on open access internet sites in a timely fashion without interpretation or discussion.
So where does this leave publication planning? Successful publication of original research, supportive and derivative articles helps assure that the market is ready for a product at the same time that the product is approved for the market. How can you plan for this? Well, for starters, good project management. In fact, an app like MS Project Manager can reveal the timing of key milestones from protocol to publication for all stakeholders to see. Timing? So now you know when you can begin to write about the expected study results. Your mission if you choose to accept it will be to transform clinical study summaries, which are designed mainly for regulatory authorities, into articles that journal editors, reviewers and their readers will want to read and will understand. Other questions to consider? Which journals and which readers are you going to target? What you can say about the significance of the study results in primary publications and in review articles becomes more clear when you can answer two other questions: What is already known? What do these results add that’s new?
Where do the answers come from? You or others in your team will have done a competitive product and market analysis, pulled together a library of previous relevant publications and compiled a series of key messages and target audiences. When all of this is in place you should be able to develop a “thumbnail” of each article that you want to include in your plan including a working title, clinical trial ID, target journal, estimated timing, key results and significance, objective of publication, key messages. Authorship? There are definite guidelines for choosing authors. See this from the International Committee of Medical Journal Editors: http://www.icmje.org/ethical_1author.html.
Resources? These are generally (hopefully) in place when you arrive on the scene. Human resources typically involve a “Publication Steering Committe” including numerous stakeholders from corporate Medical Affairs, Marketing, Regulatory, Writing, and often outside agencies – and others. Also, as you must have guessed, nowadays pub planning cannot be done, and the plans cannot be written, communicated and kept up to date without the help of dedicated computer software, corporate intranets and the internet.
OK – I’ve just told a few of my own views on pub planning based on my own experiences. It’s not the whole story by far, but what seems to me to be the central issues and the rationale for doing the planning well. Any questions or comments – just let me know. Cheers for now. Clem Weinberger, PhD, The Stylus Medical Communications.