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Planning Benefit-Risk Assessments Using Visualizations

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Abstract

A Benefit Risk Assessment Plan (BRAP) describes the assessments planned to determine whether the benefits of an investigational drug outweigh the risks. The plan can have two sections, one with timelines for aligning resources with decision milestones and the other for pre-specifying assessments for decision milestones. Regulatory guidance recommends a proactive planning process over an ad-hoc process. However, very little has been published about proactive plans themselves. This article works through a hypothetical example visualizing a series of assessments across the drug development lifecycle. Based on a regulatory framework, the planning process starts with assessing the medical condition and current treatment options. These early assessments bring out major considerations in assessing the investigational drug.

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Data Availability

No data is presented in this manuscript; however, further information on any of the content can be requested from the corresponding author.

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Acknowledgments

The authors thank Cindy McShea, Statistical Sciences & Innovation Safety Standards Lead, UCB BioSciences, for final edits and support.

Funding

No financial support for this article's research, authorship, or publication was declared.

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Authors and Affiliations

  1. Statistical Sciences & Innovation, UCB Biosciences, Inc, 4000 Paramount Parkway Suite 200, Morrisville, NC, 27560, USA

    Michael W. Colopy

  2. Statistical Sciences & Innovation, UCB Celltech, UCB Pharma S.A, Slough, UK

    Lovemore Gakava

  3. Statistical Sciences & Innovation, UCB Pharma S.A, Brussels, Belgium

    Chen Chen

Authors
  1. Michael W. Colopy
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  2. Lovemore Gakava
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  3. Chen Chen
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Contributions

A small internal working group developed this benefit-risk visualization methodology under the auspices of the Statistical Sciences & Innovation Safety Standards team. All authors drafted the initial manuscript, revised and approved the final manuscript draft for submission, and agreed to be accountable for all aspects of the work.

Corresponding author

Correspondence to Michael W. Colopy.

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Conflict of interest

All authors are employees of UCB Pharma and may hold UCB stock or stock options.

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Colopy, M.W., Gakava, L. & Chen, C. Planning Benefit-Risk Assessments Using Visualizations. Ther Innov Regul Sci 57, 1123–1135 (2023). https://doi.org/10.1007/s43441-023-00563-9

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  • DOI: https://doi.org/10.1007/s43441-023-00563-9

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