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Increasing Efficiency and Cost-Effectiveness by Automating the Authoring of the Development Safety Update Report

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Abstract

Introduction

A Development Safety Update Report (DSUR) is a comprehensive review of safety information collected during an annual reporting period for an investigational drug. The creation of a DSUR is a resource-intensive process, requiring effective communication among, and collaboration with, various functional stakeholders.

Objective

To increase the efficiency and cost-effectiveness of generating a DSUR with the use of an electronic authoring platform. This computerized platform auto-populates the DSUR template using available source data.

Method

Requirements for the DSUR authoring tool were developed, and available data sources were mapped to respective sections of a company DSUR template. The DSUR authoring tool, mined, scanned, and extracted the relevant data from multiple-input source documents using Natural Language Processing logic. The data were then auto-populated into the template, as required by regulatory guidance ICH-E2F, with different text options based on questions and answers. The time- and cost-savings gained through automation were analyzed for DSURs authored during 2017–2019.

Results

The DSUR contains 31 sections (20 main sections and 11 sub-sections), of which 9 were fully automated, 12 were partially automated, and 10 were not automated in this release of the automation tool. Use of the DSUR automation tool resulted in a time-savings of approximately 25% per report, corresponding to a cost saving of US$4550 per report.

Conclusion

Deployment of the automation tool reduced the time and cost required to manually produce DSURs, as well as improved the quality, compliance, and consistency of company-prepared DSURs. This tool enhanced the potential of the organization to generate larger volumes of DSURs in a timely manner, without requiring additional resources or compromising quality. This or a similar authoring automation tool could be employed in the future to generate other regulatory submission documents, which also require various source documents and cross-functional contributions.

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References

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Acknowledgements

We thank Mr. Mehul Shah, Mr. Amit Choudhari, and Ms. Sunayana Saha from Otsuka Data Sciences for their assistance in the development of the DSUR authoring tool. Medical writing and editorial support for the preparation of this manuscript was provided by Dr. Suruchi Singh and Mr. Mradul Dubey (Tata Consultancy Services Pvt. Ltd.).

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Authors and Affiliations

  1. Otsuka Pharmaceutical Development and Commercialization Inc., 508 Carnegie Center, Princeton, NJ, 08540, USA

    Krystle Pianka, Jennifer Cichone, Akshay Vashist, Nipa Parikh & Mirza Rahman

Authors
  1. Krystle Pianka
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  2. Jennifer Cichone
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  3. Akshay Vashist
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  4. Nipa Parikh
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  5. Mirza Rahman
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Corresponding author

Correspondence to Jennifer Cichone.

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Funding

The research was funded by Otsuka Pharmaceutical Development and Commercialization, Inc.

Conflict of interest

All authors are employees of Otsuka Pharmaceutical Development and Commercialization, Inc., Princeton, NJ, USA.

Ethics approval

Not Applicable.

Availability of data and material

The data generated during the study will be made available upon request.

Code availability

Not applicable

Author contributions

Mirza Rahman, Jennifer Cichone, Krystle Pianka, Nipa Parikh, and Akshay Vashist were responsible for conception, planning and design of the study along with contributing to data collection, data analysis and interpretation of the results. Akshay Vashist was also responsible for conception and design of Information Extraction, Natural Language Processing (NLP)/Natural Language Generation (NLG). All authors listed in this manuscript meet the ICMJE criteria and qualify to be the authors. All authors have made substantial contribution to the drafting and revision of the manuscript. All authors had access to the study data, provided direction and comments on the manuscript, had final approval of the document, and made the final decision about where to publish these data.

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Pianka, K., Cichone, J., Vashist, A. et al. Increasing Efficiency and Cost-Effectiveness by Automating the Authoring of the Development Safety Update Report. Pharm Med 35, 297–305 (2021). https://doi.org/10.1007/s40290-021-00401-z

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  • DOI: https://doi.org/10.1007/s40290-021-00401-z

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