Multistate modeling of clinical hold in randomized clinical trials-Reference-Cited by-同舟云学术

Multistate modeling of clinical hold in randomized clinical trials

Published:2019-12-10 Issue:3 Volume:19 Page:262-275
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Nießl Alexandra¹^ORCID,Beyersmann Jan¹,Loos Anja²

Affiliation:

1. Institute of Statistics Ulm University Ulm Germany

2. Global Biostatistics Merck KGaA Darmstadt Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.1989

Reference19 articles.

1. U.S. Food and Drug Administration.IND Application Procedures: Clinical Hold. 2013.http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm362971.htm.

2. An Analysis of US Food and Drug Administration Clinical Hold Orders for Drugs and Biologics: A Prospective Study Between 2008 and 2014

3. Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial

4. Joint modeling of progression-free survival and overall survival by a Bayesian normal induced copula estimation model

5. A statistical model for the dependence between progression-free survival and overall survival

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