Susan C. Scott, Scott Pharma Solutions Ltd, Ashwell, UK
While there are many factors, such as author selection, full disclosure and acknowledgement, and data access, that are common to planning any publication,1,2 different issues arise when managing a publication that is likely to have a big impact on the clinical community compared to a paper that merely adds to established practice. It is likely that a primary publication reporting the top-line results from a pivotal trial of a newly launched drug product will make a splash, whereas a publication on a non-interventional study of a drug that has already been marketed for several years may have more difficulty in getting published.
However, there are exceptions to this rule. For example, positive findings in a Phase 3 trial of a well-established drug in a new indication with few treatment options may well be of similar importance to a new agent in that indication; in fact, it may elicit even more interest because it already has a known safety profile. In immuno-oncology, even a study with negative results for the primary endpoint, but which shows unexpectedly high numbers of durable complete responses in specific patient sub-groups, may turn out to be practice-changing. On the other hand, the pharmacokinetic profile of a new agent will most likely appeal to a limited audience.
With the high cost of undertaking clinical research, sponsors endeavor to design programs such that the results of all their clinical studies count; however, there can be situations which do not achieve this ideal; for example, when a sponsor discontinues development of an asset, thus resulting in a manuscript that has difficulty finding a journal ”home.”
On balance, as a publication planner, it is helpful to categorize your publications into those that will have high, medium, or low impact on clinical practice, as well as whether the product is new to the market or well-established. Research the relevant literature yourself and talk to the authors; don’t just rely on the lead sponsor clinician’s assessment as it may be their pet project and they may no longer have a balanced opinion.
What Are the Factors to Consider in Publication Planning?
In addition to such obvious topics as choice of congress and journal, softer considerations, such as managing the budget and timeline differently and the authors’ and sponsor’s level of engagement, play important roles in successful publication planning for all publications. Figure 1 summarizes the key points.
Figure 1. Key Points to Consider in Publication Planning for High, Medium, and Low Impact Publications
Choice of journal. Selecting a suitable journal should ideally depend on the anticipated impact of the publication, although the authors ultimately decide on the target journal. Unless the results are truly of high clinical impact (negative or positive) in a relatively common disease that is underserved by current medical practice, the authors should be gently steered away from the best-known general medical journals, such as New England Journal of Medicine, The Lancet, etc., which have a high rejection rate. Valuable time can be lost, although one benefit is that you will know quickly whether the journal is interested in the manuscript.
In each therapeutic area, there are several specialist journals (including specialty sub-journals of the top-tier journals, such as Lancet Neurology, etc.) with different levels of influence and readership whose websites describe which topics they are interested in publishing and give good advice when consulted in a pre-submission inquiry. For an innovative study that will potentially influence clinical practice, it is often worthwhile to engage journal editors or members of editorial boards of the target journal regarding its design and objectives, perhaps as part of an advisory board or through author contact, well before the results emerge. This can pique their interest, resulting in an invitation to submit to their journal. Also consider submitting specialist material, such as health economics or pharmacokinetics, to journals dedicated to these topics.
When planning a high or medium impact publication for which you wish to achieve maximum exposure, consider choosing a journal that offers digital options, such as videoclips or infographics, and/or broadcasts important results on social media.
For a low clinical impact publication (perhaps with inconclusive results) that has already been rejected from an appropriate journal, consider if it could be re-shaped into a short communication for another journal that may improve its chance of acceptance. If still unsuccessful, you may decide to abandon the goal of publication in a scientific journal and ensure that the results are posted on a publicly available disclosure website, such as ClinicalTrials.gov or the European Clinical Trials Database (EudraCT).
Choice of congress. For every publication, carefully consider the audience and timing of the congress to first disclose the trial results. The abstract should be accepted before the manuscript is published, and the congress should preferably occur beforehand as well to raise interest. For a study with potentially high impact, the top international conference in that therapeutic area is the ideal choice, while for a medium or low impact study, a regional or national therapeutically-aligned conference should be targeted. Specialist conferences may well be the best choice for study results in pharmacology, pharmacokinetics, or health economics.
In selected rare cases of publications with high clinical impact, the sponsor and authors may coordinate with the congress organizers and journal editor to simultaneously present results publicly at the congress and publish the full manuscript. This requires a high degree of coordination and strict adherence to embargo rules.
Budget and timeline. Manuscripts and congress materials reporting data of high and medium clinical impact are usually adequately funded and appropriate time and resources allocated. With the advances in open access for all publications, factor these fees into the budget and ensure it also includes the cost of any digital enhancements. Make sure the plan includes time for preparation and review of digital material and notify reviewers in advance to expect digital, as well as traditional text and slide material, if you choose this option.
Be aware that high impact publications accepted in the top general medical journals will likely have several rounds of peer and statistical review, often with accelerated timelines, so alert the authors and other reviewers to this factor. If the manuscript is intended for publication to coincide with the launch of a new product, device, or indication, this can be a logistical headache with longer than expected peer review delaying the publication date past the launch date or, conversely, a rapid acceptance and publication before the launch is ready; explain the issue to the journal editor and enlist his or her help.
In contrast, publications with low potential impact often struggle to retain their budget and clinical, statistics, and writing resources in the face of conflicting priorities. Restricting the members of the publication team to the bare minimum and publishing only the primary data are pragmatic solutions. When sponsors discontinue development of the asset and move their staff to other projects, it can be helpful to remind senior managers of company policies and GPP3 guidelines,2 which commit to publish the results of all clinical trials and offer guidance that publications should be submitted no later than 18 months after study completion.
Author and sponsor enthusiasm. Two very different scenarios present themselves for high and low clinical impact publications with regards to author and sponsor enthusiasm.
As advised by GPP3,2 it is a good idea to set up a publication steering committee (PSC) before results are available, especially for a trial which is likely to yield results with high potential impact. This should have a charter describing members’ responsibilities and the working process. Authors drawn from the PSC must understand and agree to meet multiple document reviews with potentially very compressed timeframes, but the advantage is that both the effort and the pressure can be shared. There should be a non-disclosure agreement for PSC members, sponsor staff, and medical communication agency staff to sign and follow, avoiding premature disclosure that could jeopardize successful publication. Ensure careful coordination with Public Relations and compliance staff so that press releases are enthusiastic and accurate but do not over-reach.
Conversely, it can be difficult to maintain authors’ engagement in a publication that will have little impact; emails may be unanswered and telephone calls not returned. A practical step is to restrict the number of authors as much as is ethical, to avoid replication of the problem. Another approach is to offer a good deal of writing support, providing it is properly acknowledged. If necessary, a personal visit to the lead author(s) may help motivate them and resolve as many matters as possible.
Effective planning for publications relies on correctly identifying whether the resulting publication and congress communications will have a high, medium, or low impact on the clinical and scientific community. You are then in a position to guide such factors as choice of congress and journal, as well as anticipate, manage, and resolve potential budget, timeframe, and team motivation issues.
- International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals. Updated December 2017. Accessed at www.icmje.org/recommendations on 2 April 2018.
- Battisti WP, Wager E, Balzer L, Bridges D, Cairns A, Carswell C, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med 2015; 163: 461-464. Doi:10.7326/M15-0288.
Thanks to Farah Dunlop, PhD, at Sirtex Medical Ltd, for her constructive review.