New England Journal Of Medicine Presubmission Inquiry – Lisa Moore, PhD, ISMPP CMPPTM; Karen King, PhD, ISMPP CMPPTM; Jason Gardner, PhD, ISMPP CMPPTM, Complete Medical Communications, McCann Health Company, United Kingdom
Pharmaceutical companies are expected to responsibly share data from interventional clinical trials , and many pharmaceutical companies have committed to publishing all clinical trial data in peer-reviewed journals . In addition, the primary goal of many clinical researchers is the timely publication of a manuscript in a high-ranking journal.
New England Journal Of Medicine Presubmission Inquiry
A high-profile journal has a long-standing reputation for publishing high-quality research, a rigorous peer-review process, attracting a large global medical readership, and focusing on novel findings with major implications for general medical practice. As such, clinical trial manuscripts published in high-profile journals typically describe robust, well-performed proof-of-concept or hypothesis-testing clinical trials of pharmaceutical treatments or other interventions that address a significant unmet medical need (see Figure 1 below).
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The main advantage of publishing in a high-ranking journal is the associated confirmation of quality and relevance, and that the research has or can have a significant impact on improving outcomes in human lives. Because of this support and the broad global readership of high-profile journals, it is more likely that the medical community, including clinicians, payers, policymakers, and funding agencies, will read, acknowledge, and act upon the article. However, publishing in high-profile journals can be difficult and these journals have high rejection rates, typically up to 95% [3–5] .
Many authors consider the impact factor (IF) to be the most important feature in selecting a target journal, with a high IF journal synonymous with a high-ranking journal (see Figure 2 below for IF calculation).
IF is generally believed to build credibility for the article and its content, resulting in better exposure in the medical/scientific community. A major driver of journal selection for some academic authors is the prestige of publishing in a high-IF journal, which can strengthen the reputation of the author and the author’s institution. For medical-based research, there are three high-ranking journals according to IF
However, in today’s digital age, IF is much debated, and it is useful to consider other factors, such as time to publication (information time), rejection rate, readership, publication frequency, when giving guidance to authors on journal selection. and other broader features such as electronic IF (e.g., number of downloads of a published manuscript) and opportunities to improve the materials provided by journals. In addition, the type of content and its suitability for publication in high-profile journals is key to making an appropriate choice. Therefore, when considering publication of clinical trials in a high-ranking journal, it is usually useful to analyze recent publications both in the selected journal and in other potential target journals to assess appropriateness and novelty.
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, may, in certain cases, request submission of the manuscript after the data have been submitted at the congress, especially after late data submission. In the absence of such a request, another option is to send a pre-request to assess the journal’s interest – some journals actively encourage this . Although a pre-submission query can confirm the article’s compliance with the journal’s scope, it provides no indication of the likelihood of acceptance and can create false expectations among authors of manuscript acceptance if not managed correctly.
One of the other important considerations when choosing the right journal is timing. When selecting a target journal, authors should evaluate factors such as time required for manuscript development and estimates of time to submission for publication. Timing considerations are usually even more important when submitting to a high-profile journal, given the potential need to meet a specific publication date and/or achieve an accelerated peer review schedule, often with a larger number of authors.
Publishing in a high-profile journal requires careful consideration and planning before, during, and after manuscript submission. Once the author list has been confirmed, the manuscript development schedule is a critical tool , especially when a firm publication date is desired, such as parallel publication with data publication at a major scientific conference (which is mostly such high-profile journal publications) or publication of phase III data prior to product approval. Additionally, your article may be part of a series of publications in a multi-study Phase II or III clinical development program.
When establishing a dialogue with a high-profile journal, it is worth discussing the scope of the clinical development program with the editor of the journal, who may wish to simultaneously publish related research articles and thereby provide greater context and impact. readers – sometimes with the addition of a corresponding editorial article. This may mean expediting the development of a publication or accepting the delay of another publication if the research schedule is rescheduled. Alternatively, your article may be an interim analysis of an ongoing study or the first results of several consecutive studies. Again, dialogue with the editor will clarify whether it is preferable to publish immediately or wait until all the data are available. Authors should be prepared for these discussions by planning scenarios and aligning with authors of related publications.
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Typically, multi-author manuscript development facilitated by a professional medical writer can take six months or longer, depending on the complexity and challenges of the data and author content alignment/approval. Clinical trial pivotal publications in high-profile journals can often involve many more authors than other publications, so early involvement of authors in manuscript design and timelines is important. Indeed, with the consent and involvement of the author, it is possible to accelerate the submission deadline within two months of the manuscript’s kick-off call (especially if required for a specific scientific congress). Disagreements between authors regarding manuscript plans and content can occur at any time during manuscript development, so a proactive (“unanticipated delay”) plan should be built into development timelines.
As always, it is crucial to ensure that both the manuscript and any supporting materials are written and produced in accordance with the journal’s guidelines; failure to do so will only waste time after submission and may result in rejection. Also, some authors may wish to take time before submission and during post-submission revisions to refine the language of the manuscript. However, it is important to note that most high-profile journals make significant changes after approval to bring the manuscript into line with their own style, making extensive “embellishment” of the language redundant. The maximum number of words must also be taken into account; when most of the word count is spent on the “Methods” and “Results” sections, it leaves little room for contextualizing the findings in the “Discussion” section. Consequently, judicious use of supplementary materials for methods and results presentation can help reduce the space for important data interpretation points.
In one example, the authors intended the publication to coincide with an important international congress taking place three months after the data became available. Although in this case the target magazine
, does not advertise a pre-submission inquiry option, a positive pre-submission dialogue was established with the journal and (> 20) authors agreed on several approaches to speed up manuscript development (see Figure 3 below). In addition, the authors agreed to a “reserve journal,” which meant that the manuscript was designed for submission
Pdf) Update On The Endorsement Of Consort By High Impact Factor Journals: A Survey Of Journal
Another important planning consideration that is sometimes overlooked is the need to allow considerable time for post-submission journal comments for some high-profile journals—especially
– even if the authors have been invited to submit their data. In some cases, manuscripts describing initial phase III data may take up to 12 months to be published.
After the first submission. Although undesirable in situations where speed of publication is key, it is appropriate for situations where the time from availability of pivotal Phase III study data to final product approval is approximately 18 to 24 months.
So, your manuscript has just been approved for publication – congratulations! While this is exciting news, you may be too late if you haven’t already started preparing additional materials to expand the manuscript at publication time. Many high-profile journals offer additional features (also known as enhanced content) that bring your manuscript to life, including audio or video summaries, animations, infographics, slides, summaries, and social media capabilities. Factor these facilities into your planning (especially budget considerations and extra time for review) to ensure a return on investment.
Free Sample Letter And Advice For Drafting A Pre Submission Inquiry
Publishing in a high-profile journal is a goal for many medical researchers, but potential challenges exist even with data worthy of publication in a high-profile journal. Many of these challenges can be overcome by careful planning before and during manuscript development and by encouraging open and timely communication with authors and the target journal.
Remember: set the goal too high and you may incur costs and schedule delays as you have to redesign and resubmit to the backlog; purpose
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