Multiregional Clinical Trials in Oncology Drug Development

2016 ◽  
pp. 109-122
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Oncology Drug ◽  
Oncology Drug Development

scholarly journals The design, analysis and application of mouse clinical trials in oncology drug development

2018 ◽  
Author(s):  
Sheng Guo ◽  
Xiaoqian Jiang ◽  
Binchen Mao ◽  
Qi-Xiang Li
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Statistical Power ◽  
Objective Response ◽  
Drug Efficacy ◽  
Design Analysis ◽  
Frailty Models ◽  
Oncology Drug ◽  
Power Curves ◽  
Oncology Drug Development

AbstractMouse clinical trials (MCTs) are becoming widely used in pre-clinical oncology drug development. In this study, we provide some general guidelines on the design, analysis and application of MCTs. We first established empirical quantitative relationships between mouse number and measurement accuracy for both categorical and continuous efficacy endpoints, and showed that more mice are needed to achieve given accuracy for syngeneic models than for PDXs and CDXs. There is considerable disagreement between categorical methods on calling drug responses as objective response, indicating limitations of such approaches. We then introduced linear mixed models, or LMMs, to describe MCTs as clustered longitudinal studies, which explicitly model growth and drug response heterogeneities across mouse models and among mice within a mouse model. Several case studies were used to demonstrate the advantages of LMMs in discovering biomarkers and exploring a drug’s mechanism of action. We also introduced the additive frailty models to perform survival analysis on MCTs, which more accurately estimate hazard ratios by modeling the clustered population structures in MCTs. We performed computational simulations for LMMs and frailty models to generate statistical power curves, and showed that statistical power is close for designs with similar total number of mice at given drug efficacy. Finally, we explained how MCTs can explain discrepant results in clinical trials, hence, MCTs are more than preclinical versions of clinical trials but possess their unique values. Results in the report will make MCTs a better tool for oncology drug development.

scholarly journals Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-analysis of Clinical Trials Leading to FDA Approval

2015 ◽  
Vol 107 (11) ◽  
pp. djv253 ◽  
Author(s):  
Denis L. Fontes Jardim ◽  
Maria Schwaederle ◽  
Caimiao Wei ◽  
J. Jack Lee ◽  
David S. Hong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Meta Analysis ◽  
Oncology Drug ◽  
Fda Approval ◽  
Oncology Drug Development

scholarly journals FDA and Its Role in Drug Development

2021 ◽  
Vol 12 (3) ◽  
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Approval Process ◽  
Center Of Excellence ◽  
Oncology Drug ◽  
Advanced Practitioner ◽  
Oncology Center ◽  
Oncology Drug Development

JADPRO Live 2020 was honored to have Dr. Richard Pazdur, the Director of the Oncology Center of Excellence at the FDA, discuss recent changes to oncology drug development and the approval process, the roles of the advanced practitioner in the execution of clinical trials, and changes that have taken place as a result of the COVID-19 pandemic.

scholarly journals Next generation oncology drug development: opportunities and challenges

2009 ◽  
Vol 6 (5) ◽  
pp. 259-265 ◽  
Author(s):  
Martin E. Gutierrez ◽  
Shivaani Kummar ◽  
Giuseppe Giaccone
Keyword(s):  
Drug Development ◽  
Next Generation ◽  
Oncology Drug ◽  
Oncology Drug Development

scholarly journals Patient-derived tumour xenografts as models for oncology drug development

2012 ◽  
Vol 9 (6) ◽  
pp. 338-350 ◽  
Author(s):  
John J. Tentler ◽  
Aik Choon Tan ◽  
Colin D. Weekes ◽  
Antonio Jimeno ◽  
Stephen Leong ◽  
...  
Keyword(s):  
Drug Development ◽  
Oncology Drug ◽  
Oncology Drug Development ◽  
Tumour Xenografts

Cardiovascular Safety Monitoring During Oncology Drug Development and Therapy

2014 ◽  
Vol 21 (6) ◽  
pp. 512-522 ◽  
Author(s):  
J. Rick Turner ◽  
Gopi Krishna Panicker ◽  
Dilip R. Karnad ◽  
Christopher H. Cabell ◽  
Ronald Lieberman ◽  
...  
Keyword(s):  
Drug Development ◽  
Safety Monitoring ◽  
Cardiovascular Safety ◽  
Oncology Drug ◽  
Oncology Drug Development

Abstract 529: Characterization of a humanized TLR8 mouse model and its application in immuno-oncology drug development

2021 ◽  
Author(s):  
Hongjuan Zhang ◽  
Ruilin Sun ◽  
Annie X. An ◽  
Henry Q.x Li ◽  
Davy Xuesong Ouyang
Keyword(s):  
Mouse Model ◽  
Drug Development ◽  
Oncology Drug ◽  
Oncology Drug Development
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