Publishing real-world evidence (RWE) research involves a comprehensive journey of strategic planning, collaborative alignment, and clear communication from initial study design to the final publication. Therefore, the publication process begins long before the first word of an abstract or manuscript is written—considerations for the final publication start at the research design stage. Success in publishing RWE hinges on consistent, transparent, and proactive stakeholder interaction.
Successful RWE research demands early and ongoing communication between medical experts/potential authors, researchers, and publication professionals. This alignment starts during study design, where teams must ensure that the research objectives will meaningfully contribute to the body of literature, predict potential challenges in publishing the findings (e.g., sample size, limited applicability of the data), and proactively develop solutions and/or explanations for study limitations. Identifying and following appropriate consensus reporting guidelines before the study is designed will help kick-start an effective process from conception to final publication. Several consensus reporting guidelines are available via the EQUATOR Network. Commonly used checklists for RWE research are STROBE, CHEERS, SRQR, and CROSS.
Publication Considerations During Study Design
Aside from the study design details and methodology, other factors should be considered at this stage. Obtaining institutional review board (IRB) approval or exemption from an independent ethics committee before research commences is critical to seamless publication. In addition to ensuring ethical compliance, this step prevents journal desk rejection related to ethical concerns. Researchers must meticulously document why research might be exempt and include detailed explanations in their submission. Diversity in authorship affiliation can also enhance the credibility of the publication. Including external experts alongside the sponsor researchers during the research design phase can mitigate potential perceptions of industry bias, adding depth and objectivity to the research narrative. Bias can also be reduced by completing a literature review before developing the study materials. The literature review will inform the study design and methods and minimize the risk of conducting duplicative research that will be difficult to publish. Finally, using consensus reporting checklists and incorporating key elements within the research is not only best practice for research design and manuscript development, but journals often require completed checklists with submissions.
Author Alignment on Data Interpretation
Aligning the sponsor’s goals for publishing data with the authors during the initial data review is another critical step in the journey toward RWE publishing. Therefore, researchers, sponsor authors, and the medical writing team should prepare for an all-author kickoff meeting. During the author meeting, discuss the study objectives, review key figures and tables for upcoming publications, and discuss data interpretation. Ensure all key topics are discussed, both positive (i.e., contribution to patient care) and negative (i.e., study drawbacks or limitations).
Navigating Journal Selection
Selecting the right journal for RWE publication is an art that requires strategic thinking. First, consider who will be best positioned to apply the results to improve patient care. For RWE research, common audiences include clinicians (physicians, advanced practice providers, or nurses), pharmacists, health system managers or payers, and other researchers. Once the audience has been selected, consider the type of journal that is the best fit. Instead of pursuing the highest-tier aspirational journals, consider where similar types of research have previously been published and double-check the journal’s aims and scope to ensure alignment. The author meeting is the ideal time to choose a primary journal for manuscript submission and alternative journals in case of rejection. Lastly, consider sending a pre-submission inquiry to the first-choice journal editor, including the title and a brief description of the manuscript in development.
Manuscript Development
Developing a successful RWE manuscript demands rigor equal to the research itself. A compelling publication articulates knowledge gaps and the study’s rationale, provides comprehensive methodology, and explicitly addresses how the results do and do not add to the existing literature. Including detailed study design figures, explaining potential limitations, and demonstrating research value are crucial elements of an effective RWE manuscript. Clearly describing the study design elements, sampling constraints, methodological nuances, and the study strengths in the cover letter and manuscript can preemptively allay concerns that the journal editor or peer reviewers may raise. Finally, the relevant consensus guideline checklist should be submitted alongside the IRB approval or exemption letter.
Journal peer review feedback should be regarded as an opportunity for improvement rather than an obstacle. Addressing reviewer feedback necessitates meticulous attention to detail and a professional attitude. Each comment warrants a thoughtful and comprehensive response detailing the changes made and justifications for preserving the original text when revisions are not incorporated.
The final, often overlooked stage of the publication journey is post-publication evaluation and feedback. Organizations can create a cycle of continuous improvement by capturing success metrics, analyzing performance indicators, and systematically sharing peer review feedback with research teams. This feedback loop allows teams to iteratively enhance their research design, publication strategies, and communication approaches. Each publication becomes a learning opportunity, driving increasingly sophisticated and impactful RWE research.
Successful RWE publication is a dynamic and collaborative journey. Research teams can transform complex real-world data into meaningful, credible scientific communications that drive healthcare understanding and innovation by embracing a collective approach that engages all stakeholders from strategic planning through final publication of RWE research findings.
Authors
Rebecca Hahn, MPH, CMPP
Medical & Scientific Communications, Sr. Director
Rebecca is a medical writer specializing in scientific publications of real-world evidence, including HEOR and patient-reported outcomes research. As a certified medical publication professional, she effectively communicates complex research across many therapeutic areas to a variety of audiences via manuscripts and conference abstracts/posters.
Nicole Garberg
Head of Real World Evidence
Nicole has been consulting with clients across all areas of the healthcare industry for 20+ years. Her expertise in patient experience, QoL and journey mapping is leveraged to improve patient outcomes and business performance for her clients and their patients. Nicole holds a MS in Experimental Psychology and BA degrees in Psychology & Sociology.
Laura McCormick, PhD
Medical & Scientific Communications, VP
Laura is a seasoned Medical Affairs and Publications professional with more than 20 years of experience guiding clients toward innovative solutions to meet their communications needs. As VP, Medical & Scientific Communications at KJT, Laura oversees the writing and project management team to ensure quality.
