Monitoring potential adverse event rate differences using data from blinded trials: the canary in the coal mine-Reference-Cited by-同舟云学术

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

Published:2016-09-25 Issue:1 Volume:36 Page:92-104
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statist. Med.

Author:

Gould A. Lawrence¹^ORCID,Wang William B.¹

Affiliation:

1. Merck Research Laboratories; Upper Gwynedd PA 19454 U.S.A.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference32 articles.

1. Data Monitoring Committees in Clinical Trials

2. Data and Safety Monitoring Committees in Clinical Trials

3. EMEA Reflection paper on risk based quality management in clinical trials European Medicines Agency 2013 http://www.ema.europa.eu/docs/en_GB/document_library/

4. FDA Oversight of clinical investigations-a risk-based approach to monitoring Food and Drug Administration 2013 http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm269919.pdf

Cited by 15 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials;Pharmaceutical Statistics;2022-12-12

2. 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;Pharmaceutical Statistics;2021-11-02

3. Monitoring scheme for early detection of coronavirus and other respiratory virus outbreaks;Computers & Industrial Engineering;2021-06

4. Aggregate Safety Assessment Planning for the Drug Development Life-Cycle;Therapeutic Innovation & Regulatory Science;2021-03-23

5. Statistical methods for the analysis of adverse event data in randomised controlled trials: a scoping review and taxonomy;BMC Medical Research Methodology;2020-11-30