A hierarchical testing approach for detecting safety signals in clinical trials-Reference-Cited by-同舟云学术

A hierarchical testing approach for detecting safety signals in clinical trials

Published:2020-05-15 Issue:10 Volume:39 Page:1541-1557
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Tan Xianming¹^ORCID,Chen Bingshu E.²,Sun Jianping³,Patel Tejendra⁴,Ibrahim Joseph G.¹^ORCID

Affiliation:

1. Department of BiostatisticsUNC at Chapel Hill Chapel Hill North Carolina

2. Canadian Cancer Trials Group and Department of Public Health SciencesQueen's University Kingston Ontario Canada

3. Department of Mathematics and StatisticsUNC at Greensboro Greensboro North Carolina

4. Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of PharmacyUNC at Chapel Hill Chapel Hill North Carolina

Funder

Natural Sciences and Engineering Research Council of Canada

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sim.8495

Reference38 articles.

1. ICH ICH editor ICH safety guidelines; 2013.http://www.ich.org/products/guidelines/safety/article/safetyguidelines.html. Published October 29 2013.

2. US Department of Health Human Services & Food and Drug Administration. Guidance for industry and investigators safety reporting requirements for INDs and BA/BE Studies; 2010.

3. Communication from the commission: ECC EC editor Detailed guidance on the collection verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ('CT‐3'). 2011.http://www.kme‐nmec.si/Docu/ct‐3.pdf. Published January 10 2017.

4. Planning and core analyses for periodic aggregate safety data reviews

Cited by 4 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. Improved Apriori Method for Safety Signal Detection Using Post-Marketing Clinical Data;Mathematics;2024-08-30

2. Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection;Therapeutic Innovation & Regulatory Science;2022-01-22

3. Assessing safety at the end of clinical trials using system organ classes: A case and comparative study;Pharmaceutical Statistics;2021-06-24

4. c212: An R Package for the Detection of Safety Signals in Clinical Trials Using Body-Systems (System Organ Classes);Journal of Open Source Software;2020-12-04