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Blinded Safety Signal Monitoring for the FDA IND Reporting Final Rule

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Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics

Part of the book series: ICSA Book Series in Statistics ((ICSABSS))

Abstract

We introduce a safety monitoring procedure for two-arm blinded clinical trials. This procedure incorporates a Bayesian hierarchical model for using prior information and pooled event rates to make inferences on the rate of adverse events of special interest in the test treatment arm. We describe a collaborative process for specifying the prior and calibrating the operating characteristics.

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Acknowledgments

We would like to thank Ann Eldred, Seemi Khan, Holly Read, Syed Islam, Karolyn Kracht, Shihua Wen and Jyotirmoy Dey of AbbVie for evaluating the process with an earlier version of our method.

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Authors and Affiliations

  1. Biostatistics and Research Decision Sciences, Merck Research Laboratories, 126 E Lincoln Ave, Rahway, NJ, 07065-4607, USA

    Greg Ball

  2. Division of Biostatistics, School of Public Health, University of Minnesota, 420 Delaware St SE, Minneapolis, MN, 55455-0381, USA

    Patrick M. Schnell

Authors
  1. Greg Ball
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  2. Patrick M. Schnell
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Corresponding author

Correspondence to Greg Ball .

Editor information

Editors and Affiliations

  1. Global Statistics, Takeda Pharmaceuticals, Cambridge, Massachusetts, USA

    Jianchang Lin

  2. Biostatistics, Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, USA

    Bushi Wang

  3. Colorado State University , Fort Collins, Colorado, USA

    Xiaowen Hu

  4. University of Connecticut , Storrs, Connecticut, USA

    Kun Chen

  5. Global Statistics, Takeda Pharmaceuticals Global Statistics, Cambridge, Massachusetts, USA

    Ray Liu

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© 2016 Springer International Publishing Switzerland

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Ball, G., Schnell, P.M. (2016). Blinded Safety Signal Monitoring for the FDA IND Reporting Final Rule. In: Lin, J., Wang, B., Hu, X., Chen, K., Liu, R. (eds) Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics. ICSA Book Series in Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-42568-9_17

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