A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials-Reference-Cited by-同舟云学术

A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials

Published:2022-12-12 Issue:2 Volume:22 Page:378-395
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Brock Kristian¹^ORCID,Chen Chen²,Ho Shuyen³,Fuller Greg⁴,Woolfolk Jared⁵,McShea Cindy³,Penard Nils⁶

Affiliation:

1. Centre for Excellence in Statistical Innovation UCB Pharma Slough UK

2. Safety Standards UCB Pharma Brussels Belgium

3. Safety Standards UCB Biosciences Morrisville North Carolina USA

4. PBS Cytel Geneva Switzerland

5. PBS Cytel Inc Waltham Massachusetts USA

6. Safety Standards UCB France Colombes France

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2278

Reference20 articles.

1. US Department of Health and Human Services Food and Drug Administration “Code of Federal Regulations Title 21 Food and Drugs Chapter 1 Food and Drug Administration Department of Health and Human Services Subchapter D Drugs for Human Use Part 312 Investigational New Drug Application ”2010.

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– safety reporting requirements and safety assessment for IND and bioavailability/bioequivalence studies; Draft Guidance for Industry ”2021.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. Aggregate Safety Assessment Planning for the Drug Development Life-Cycle

4. US Department of Health and Human Services Food and Drug Administration “Meta‐analyses of randomized controlled clinical trials to evaluate the safety of human drugs or biological products; Draft Guidance for Industry ”2018.

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