A bivariate Bayesian framework for simultaneous evaluation of two candidate companion diagnostic assays in a new drug clinical trial-Reference-Cited by-同舟云学术

A bivariate Bayesian framework for simultaneous evaluation of two candidate companion diagnostic assays in a new drug clinical trial

Published:2021-04-25 Issue:2 Volume:5 Page:207-217
ISSN:2470-9360
Container-title:Biostatistics & Epidemiology
language:en
Short-container-title:Biostatistics & Epidemiology

Author:

Simon Richard M.¹^ORCID,Wang Songbai²^ORCID

Affiliation:

1. R Simon Consulting, Potomac, MD, USA

2. Janssen Pharmaceutical Research and Development, Raritan, NJ, USA

Publisher

Informa UK Limited

Subject

Health Informatics,Epidemiology

Link

https://www.tandfonline.com/doi/pdf/10.1080/24709360.2021.1913705

Reference22 articles.

1. FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation–Positive Non–Small Cell Lung Cancer

2. FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the BRAFV600 Mutation

3. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

4. FDA. Draft guidance for industry and food and drug administration staff: principles for codevelopment of an in vitro companion diagnostic device with therapeutic product 2014. Available from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM510824.pdf.

5. Statistical evaluation of drug efficacy for bridging study in companion diagnostic test trials

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