Improving Risk Assessment in Clinical Trials: Toward a Systematic Risk-Based Monitoring Approach

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Fneish, F.; Schaarschmidt, F.; Fortwengel, G.: Improving Risk Assessment in Clinical Trials: Toward a Systematic Risk-Based Monitoring Approach. In: Current Therapeutic Research - Clinical and Experimental 95 (2021), 100643. DOI:

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Sum total of downloads: 38

Regulatory authorities have encouraged the usage of a monitoring (RBM) system in clinical trials before trial initiation for detection of potential risks and inclusion of a mitigation plan in the monitoring strategy. Several RBM tools were developed after the International Council for Harmonization gave sponsors the flexibility to initiate an approach to enhance quality management in a clinical trial. However, various studies have demonstrated the need for improvement of the available RBM tools as each does not provide a comprehensive overview of the characteristics, focus, and application. This research lays out a rationale for a risk methodology assessment (RMA) within the RBM system. The core purpose of RMA is to deliver a scientifically based evaluation and decision of any potential risk in a clinical trial. Thereby, a monitoring plan can be developed to elude prior identified risk outcome. To demonstrate RMA's theoretical approach in practice, a Shiny web application (R Foundation for Statistical Computing) was designed to describe the assessment process of risk analysis and visualization tools that eventually aid in focusing monitoring activities. RMA focuses on the identification of an individual risk and visualizes its weight on the trial. The scoring algorithm of the presented approach computes the assessment of the individual risk in a radar plot and computes the overall score of the trial. Moreover, RMA's novelty lies in its ability to decrease biased decision making during risk assessment by categorizing risk influence and detectability; a characteristic pivotal to serve RBM in assessing risks, and in contributing to a better understanding in the monitoring technique necessary for developing a functional monitoring plan. Future research should focus on validating the power of RMAs to demonstrate its efficiency. This would facilitate the process of characterizing the strengths and weaknesses of RMA in practice. © 2021 The Author(s)
License of this version: CC BY-NC-ND 4.0 Unported
Document Type: Article
Publishing status: publishedVersion
Issue Date: 2021
Appears in Collections:Naturwissenschaftliche Fakultät

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pos. country downloads
total perc.
1 image of flag of Germany Germany 18 47.37%
2 image of flag of United States United States 9 23.68%
3 image of flag of India India 3 7.89%
4 image of flag of China China 3 7.89%
5 image of flag of Taiwan Taiwan 1 2.63%
6 image of flag of Netherlands Netherlands 1 2.63%
7 image of flag of Iran, Islamic Republic of Iran, Islamic Republic of 1 2.63%
8 image of flag of Spain Spain 1 2.63%
9 image of flag of Canada Canada 1 2.63%

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