Phase II Dose Finding

Qiqi Deng and Naitee Ting ()
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Qiqi Deng: Boehringer-Ingelheim Pharmaceuticals, Inc., Department of Biostatistics and Data Sciences
Naitee Ting: Boehringer-Ingelheim Pharmaceuticals, Inc., Department of Biostatistics and Data Sciences

A chapter in Statistical Methods in Biomarker and Early Clinical Development, 2019, pp 301-320 from Springer

Abstract: Abstract In the process of new drug discovery and development, understanding the dose–response relationship is one of the most challenging tasks. It is also critical to identify the right range of doses in early stages of clinical development so that Phase III trials can be designed to confirm some doses within this range. Usually at the beginning of Phase II, there is not a lot of available information to help guide the study design. At this stage, Phase II clinical studies are needed to establish proof-of-concept (PoC), to identify a set of potentially effective and safe doses, and to estimate dose–response relationships. Challenges in designing these studies include: selection of the dose frequency and the dose range, choice of clinical endpoints or biomarkers, and use of control(s), among others. Consequences of bad Phase II study designs may lead to the delay of the entire clinical development program or the wastage of R&D investment. In fact, the entire drug development process can be viewed as a scientific search of right doses—starting from discovery, up to clinical Phases I, II, III, and IV—is a process to find one or a few efficacious and safe doses.

Date: 2019
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DOI: 10.1007/978-3-030-31503-0_14

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