Bayesian methods for design and analysis of safety trials-Reference-Cited by-同舟云学术

Bayesian methods for design and analysis of safety trials

Published:2013-07-30 Issue:1 Volume:13 Page:13-24
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Price Karen L.¹,Amy Xia H.²,Lakshminarayanan Mani³,Madigan David⁴,Manner David¹,Scott John⁵,Stamey James D.⁶,Thompson Laura⁷

Affiliation:

1. Eli Lilly and Company; Indianapolis IN USA

2. Amgen Inc.; Thousand Oaks CA USA

3. Merck Research Laboratories; North Wales PA USA

4. Department of Statistics; Columbia University; New York NY USA

5. Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research; FDA; Silver Spring MD USA

6. Department of Statistics; Baylor University; Waco TX USA

7. Office of Surveillance and Biometrics; Center for Devices and Radiological Health, FDA; Silver Spring MD USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pst.1586/fullpdf

Reference67 articles.

1. Management of Safety Information from Clinical Trials - Report of CIOMS Working Group VI

2. United States Food and Drug Administration Guidance for Industry: Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf

3. United States Food and Drug Administration Use of Bayesian Statistics in Medical Devices Clinical Trials - Guidance for Industry and FDA Staff 2010 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071121.pdf

4. Bayesian approaches to randomized trials (with discussion);Spiegelhalter;Journal of the Royal Statistical Society (Series A),1994

5. Comparison of Bayesian with group sequential methods for monitoring clinical trials;Freedman;Controlled Clinical Trials,1998

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