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Follow-up on the Use of Advanced Analytics for Clinical Quality Assurance: Bootstrap Resampling to Enhance Detection of Adverse Event Under-Reporting

Drug Safety volume 44, pages 121–123 (2021)Cite this article

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Fig. 1

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Acknowledgements

Content review was performed by Melissa Preovolos who was employed by Roche at the time this research was completed.

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Affiliations

  1. F. Hoffmann-La Roche AG, Basel, Switzerland

    Björn Koneswarakantha, Yves Barmaz & Timothé Ménard

  2. Roche Product Ltd., Welwyn Garden City, UK

    Donato Rolo

Authors
  1. Björn Koneswarakantha
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  2. Yves Barmaz
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  3. Timothé Ménard
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  4. Donato Rolo
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Corresponding author

Correspondence to Timothé Ménard.

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Funding

Roche provided funding for this work.

Conflicts of interest/competing interests

Björn Koneswarakantha, Yves Barmaz, Donato Rolo and Timothé Ménard were employed by Roche at the time this research was completed.

Ethics approval

All human subject data used in this analysis were used in a de-identified format. Ethics approval is not applicable.

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Data availability and material

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

Code availability

The code is available at https://github.com/openpharma/simaerep/.

Authors’ contributions

BK designed the model, wrote the code and produced the figure. BK and TM wrote the manuscript. TM, YB and DR reviewed and quality checked the data, code, model and manuscript. All authors read and approved the final version.

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Koneswarakantha, B., Barmaz, Y., Ménard, T. et al. Follow-up on the Use of Advanced Analytics for Clinical Quality Assurance: Bootstrap Resampling to Enhance Detection of Adverse Event Under-Reporting. Drug Saf 44, 121–123 (2021). https://doi.org/10.1007/s40264-020-01011-5

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  • DOI: https://doi.org/10.1007/s40264-020-01011-5