Developing subject narratives from clinical study data is often a manual, tedious, and time-consuming task for medical writers and/or safety specialists. Narratives typically include summary information regarding subject demographics and baseline characteristics, adverse events (AEs) and serious adverse events (SAEs), as well as laboratory values. These data are provided in statistical outputs (eg, tables and listings), which historically are then manually copied/pasted into the narratives. In addition, a list of subjects requiring a narrative must be manually developed based on the study-specific criteria used and the actual narratives generated. Altogether, this results in additional costs, resources, and project time to develop the narratives and then verify their data via quality check (QC) review.
Our client, a large pharmaceutical company, conducted an evaluation of their subject narrative management process and found the following:
Based on these findings, our client wanted to see if there was a way to automate the narratives generation process using a simple-to-use utility that capitalized on existing tools and systems.
Initially, ArborSys collaborated closely with the client to identify the business requirements for the automated narratives utility. Some of these key requirements included:
ArborSys worked with the client to define a ‘core’ subject narrative template to use as the starting point for all TAs; this was to ensure consistency in the generated narratives in terms of both format and the baseline data included (eg, demographics and medical history data points). In addition, multiple TA-specific templates were developed based on the ‘core’ requirements, to allow for the automated inclusion of additional data points for a specific TA. Once all the templates’ prespecified data points were identified, ArborSys worked with the client to map where the source data originated from in the CRFs and/or SDTM datasets; the client’s statistical programming group then provided an MS Excel output of the required data in the correct format.
Once all the requirements and data specifications were agreed upon, ArborSys developed an MS Word-based utility that would address these needs by providing the following capabilities:
An overview of the utility’s end-to-end process is illustrated below.
After production deployment, the new utility immediately yielded positive results such as increased narratives quality, reduced development time, and decreased costs. Initial savings were estimated to range from 30-57% based on the TA; actual savings ranged from 67% for a more complex TA such as oncology, to 25% for a simpler TA such as primary care. Auto-population of prespecified data points reduced the need for downstream data verification and QC review. It also expedited the development of the narrative itself, because the author could focus on writing the narrative text, and not have to tediously find and then copy/paste the required data from the statistical outputs. Utilization of TA-specific templates ensured consistency in the generated narratives, so that teams did not have to “recreate the wheel” each time; standard file naming conventions and a subject list facilitated easy navigation of the narratives within the CSR by Health Agencies’ or other reviewers.
In fact, some time after the initial utility was released, the client asked ArborSys to develop another utility to assist with the compilation of all the individual subject narratives, along with the narratives list, into a single combined document that becomes an appendix of the CSR. This additional utility allowed a user to specify which section in the combined document the narratives should be inserted, and then automatically placed each narrative into its proper section, along with the appropriate bookmarks and hyperlinks, for more efficient PDF publishing as part of the CSR downstream. With the introduction of this supplemental utility, additional savings of 33-45% was realized in the narratives compilation process.
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