Model assisted designs for early phase clinical trials: simplicity meets superiority

J Clin Oncol

30 October 2019 - 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 modelling, 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.

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Michael Wonder

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Michael Wonder