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© 2015 Elsevier Inc. All rights reserved. Early clinical trials are pivotal steps in the humanization of a drug development project. Their design has to accomplish both regulatory aspects as well as scientific gain regarding the drug target, human mechanism of action, and viable biomarkers; they should ultimately support proof-of-concept as early as possible. This chapter details the basic characteristics of such trials and shows the opportunities elicited by smart designs of exploratory trials, exploratory investigational new drug (eIND) filing, microdosing studies, early decision making, adaptive trial design, and the combination of regulatory and exploratory trials. All this aims at accelerating proof-of-concept as a major value inflection point of drug development.

Original publication

DOI

10.1016/B978-0-12-800687-0.00022-0

Type

Chapter

Book title

Principles of Translational Science in Medicine: From Bench to Bedside: Second Edition

Publication Date

07/04/2015

Pages

217 - 225