Applications of Adaptive Designs in Generic Drug Development

2020 ◽  
Author(s):  
Jieon Lee ◽  
Kairui Feng ◽  
Mingjiang Xu ◽  
Xiajing Gong ◽  
Wanjie Sun ◽  
...  
Keyword(s):  
Drug Development ◽  
Generic Drug ◽  
Adaptive Designs

scholarly journals Model-Assisted Designs for Early-Phase Clinical Trials: Simplicity Meets Superiority

2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ying Yuan ◽  
J. Jack Lee ◽  
Susan G. Hilsenbeck
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Late Onset ◽  
Single Agent ◽  
Adaptive Designs ◽  
Superior Performance ◽  
Delayed Response ◽  
Phase I Clinical Trials ◽  
Phase Ii Trials ◽  
Major Barrier

Drug development enterprise is struggling because of prohibitively high costs and slow progress. There is urgent need for adoption of novel adaptive designs to improve the efficiency and success of clinical trials. A major barrier is that many conventional designs are inadequate for modern drug development, yet most novel adaptive designs are difficult to understand, require complicated statistical modeling, demand complex computation, and need expensive infrastructure for implementation. The objective of this article is to introduce and review a class of novel adaptive designs, known as model-assisted designs, to remove this barrier and increase the use of novel adaptive designs. Model-assisted designs enjoy superior performance comparable to more complicated, model-based adaptive designs, but their decision rule can be pretabulated and included in the protocol—thus implemented as simply as the conventional designs. We review state-of-the-art model-assisted designs for phase I clinical trials for single-agent, drug-combination and late-onset toxicity scenarios. We also briefly introduce model-assisted designs for phase II trials to handle binary, coprimary endpoints and delayed response. Freely available user-friendly software and trial examples (trialdesign.org) facilitate the adoption of model-assisted designs.

Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group

2006 ◽  
Vol 16 (3) ◽  
pp. 275-283 ◽  
Author(s):  
Paul Gallo ◽  
Christy Chuang-Stein ◽  
Vladimir Dragalin ◽  
Brenda Gaydos ◽  
Michael Krams ◽  
...  
Keyword(s):  
Drug Development ◽  
Working Group ◽  
Adaptive Designs ◽  
Executive Summary ◽  
Clinical Drug Development ◽  
Clinical Drug
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