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References
Menard T, Barmaz Y, Koneswarakantha B, Bowling R, Popko L. Enabling data-driven clinical quality assurance: predicting adverse event reporting in clinical trials using machine learning. Drug Saf. 2019;42(9):1045–53.
Menard T, Koneswarakantha B, Rolo D, Barmaz Y, Bowling R, Popko L. Follow-up on the use of machine learning in clinical quality assurance: can we detect adverse event under-reporting in oncology trials? Drug Saf. 2020;43(3):295–6.
Fujita S, Seto K, Ito S, Wu Y, Huang CC, Hasegawa T. The characteristics of patient safety culture in Japan, Taiwan and the United States. BMC Health Serv Res. 2013;14(13):20.
Efron B. Bootstrap methods: another look at the jackknife. Ann Stat. 1979;7(1):1–26.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. E26(R2) Guideline for Good Clinical Practices. 2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. Accessed 6 Aug 2020.
Koneswarakantha B. Simulate adverse event reporting in clinical trials (R package), release v.0.1.0. https://github.com/openpharma/simaerep/. Accessed 29 Sep 2020.
Acknowledgements
Content review was performed by Melissa Preovolos who was employed by Roche at the time this research was completed.
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Roche provided funding for this work.
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Björn Koneswarakantha, Yves Barmaz, Donato Rolo and Timothé Ménard were employed by Roche at the time this research was completed.
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All human subject data used in this analysis were used in a de-identified format. Ethics approval is not applicable.
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Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
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The code is available at https://github.com/openpharma/simaerep/.
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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