Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation-Reference-Cited by-同舟云学术

Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation

Published:2021-11-02 Issue: Volume: Page:
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Waterhouse Brian¹^ORCID,Hartford Alan²^ORCID,Mukhopadhyay Saurabh³^ORCID,Ferguson Ryan⁴,Hendrickson Barbara A.⁵

Affiliation:

1. Biostatistics and Research Decision Sciences Merck Research Laboratories Upper Gwynedd Pennsylvania USA

2. Statistical & Quantitative Sciences Takeda Pharmaceutical Co. Limited Cambridge Massachusetts USA

3. Statistical Innovation, Data and Statistical Sciences AbbVie Inc. North Chicago Illinois USA

4. Process Data Analytics AbbVie North Chicago Illinois

5. Pharmacovigilance and Patient Safety AbbVie North Chicago Illinois

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2175

Reference15 articles.

1. ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.

2. US Department of Health and Human Services Food and Drug Administration.Sponsor responsibilities – safety reporting requirements and safety assessment for IND and bioavailability/bioequivalence studies; Draft Guidance for Industry;2021.

3. Safety Monitoring in Clinical Trials

4. A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

5. Monitoring potential adverse event rate differences using data from blinded trials: the canary in the coal mine

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