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Why Consistency in Patient Safety Narratives is Crucial

“You would not be able to tell 40 different writers were authoring these. It looked as though one person was writing them! The writers wrote a streamlined and visually-cohesive and consistent story that made reviewing the large set by only a few reviewers extremely efficient. This software is extremely valuable.”
— Associate Director, Medical Writing

Narrative writing is an integral part of medical writing services. Sponsors are asked to deliver large batches of these deliverables in short periods while most traditional methods prove unsuccessful in providing both consistency and quality. This can lead to questions and potential discrepancies in the reporting of a drug’s safety. Fortunately, through the advancement and use of technology, there are options to deliver patient safety narratives on time, the right way.

What are Patient Safety Narratives?

Patient safety narratives are documents that contain brief descriptions of adverse events (AEs) or adverse drug reactions (ADRs) experienced by participants during a clinical study (or by patients while taking a marketed product).​ Safety narratives are required components of Clinical Study Reports (CSRs) in all phases and included as an appendix to the report. They are also required to support pharmacovigilance activities (eg, Periodic Safety Update Reports [PSURs]).​

Narratives follow a specific Style Guide—the sponsor’s set of rules for style and presentation—and a unique template for writing while providing a full and clinically relevant, chronological account of the progression of an event experienced during or immediately following a clinical study.

Narratives may also be submitted to the Food and Drug Administration (FDA)/other regulatory health authorities if the regulatory authority identifies and requests narratives for any event/s of interest due to safety concerns. Or, narratives may be submitted for the Data Safety Monitoring Board review if there are any safety concerns for the study drug which need evaluation by an independent committee on an ongoing basis.

Regulatory authorities review narratives to evaluate whether the data are suitable for support of the safety analysis; to identify and closely examine AEs/serious AEs that require further monitoring; and to identify and monitor frequency, severity, and seriousness of unexpected AEs; to name a few objectives.

Challenges in Narrative Production

A major challenge in narrative production comes with high volume, and that is ensuring consistency. Consistency means saying the same thing, in the same way, each time and in each place, whether it be the standard template language used or how data is presented to align with the template language. Depending on the phase of the trial or the number of participants, the patients that meet the criteria for writing a narrative may be as few as a handful or as many as thousands.

Experience shows when there are thousands of narratives to write, the source material is dense and the writing team is large. The data to include in the narrative template may be dense and complex depending on the trial size and the health of the patient population. As a result, it may be difficult to write in summary or report language and difficult to harmonize across narratives.

On any team, every writer has his/her writing style, no matter how closely the writer thinks he/she is following the template (some things can be interpreted at the discretion of the writer, right?). While some deviations from the template are acceptable for special cases and data, too many may result in the template reading sloppy and contribute to overall inconsistency in the deliverable set. What if an agency reviewer identifies major inconsistencies between the ways you are reporting the same or similar data across your narratives? What if these inconsistencies result in unclear safety messaging and introduce questions and potential discrepancies in the drug’s safety? The agency could ultimately reject the drug/submission.

Guaranteeing Consistency in Patient Narratives

Certara can guarantee consistency, while working with a hefty team, in a large narrative submission through the use of technology-enabled authoring. Our unique software, Synchrogenix Writer, enables us to map clinical data to narrative templates while setting standards for presentation. We move beyond dragging and dropping in data to also apply sophisticated logic and code to the templates we build. The template that is produced guarantees an abidance to the standardization of the data that is pulled in and the surrounding template text. The writing team then uses this template without the need to edit the programmed text. No edits mean no potential to introduce inconsistencies.

Implementing technology in your process from the start saves time and money, avoids the need for rounds of revisions, and ensures uniformity throughout the drafting efforts. Using technology to create a template, paired with producing samples to align expectations at kickoff allows the sponsor and writing team to prepare the best narratives for the submission. Consistency is key in all submissions and provides for a higher quality product for regulatory reviewers.

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About the author

Gabriella Mangino
By: Gabriella Mangino

Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.

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