Clinical effectiveness: An approach to clinical trial design more relevant to clinical practice, acknowledging the importance of individual differences

Pain ◽  
2010 ◽  
Vol 149 (2) ◽  
pp. 173-176 ◽  
Author(s):  
R. A. Moore ◽  
S. Derry ◽  
H. J. McQuay ◽  
S. Straube ◽  
D. Aldington ◽  
...  
2010 ◽  
Vol 138 (5) ◽  
pp. S-379
Author(s):  
Brennan M. Spiegel ◽  
Roger E. Bolus ◽  
Lucinda A. Harris ◽  
Susan L. Lucak ◽  
Eric Esrailian ◽  
...  

2021 ◽  
Author(s):  
Luis Pérez Díaz ◽  
Susana Millán ◽  
Nuran Chaban ◽  
Ana del Campo ◽  
Eduardo Spitzer

Monoclonal antibodies are highly complex, large and biologic products with a substantial impact on the clinical management of a variety of diseases including cancer. The expiry of patents for essential monoclonal antibodies in cancer care such as bevacizumab, rituximab and trastuzumab, has prompted the global development of biosimilars to balance the biologics market. However, an understanding of the different approach of biosimilar development compared with its reference medicinal product, especially in the context of clinical trial design and end point selection may help oncologists integrating biosimilars into clinical practice. Herein, we reviewed the clinical development of biosimilars in oncology comparing the available clinical data of proposed biosimilars of bevacizumab, rituximab and trastuzumab.


Author(s):  
Jessica J. Waninger ◽  
Michael D. Green ◽  
Catherine Cheze Le Rest ◽  
Benjamin Rosen ◽  
Issam El Naqa

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