Keywords: Decision Criteria, Early Design, Bayesian
Many decisions in drug development are made before the decision to submit NDA and MAAs. Often times the decision requirements that support registration are not the same as those needed to support the more exploratory early phase of drug development. In particular, much of the risk of development is assumed by the sponsor companies themselves. As such, different levels of risk can be considered. A dual target approach meant to incorporate external results in the decision making process will be presented along with dECiDe a tool co-developed by Cytel and AstraZeneca which supports the efficient generation of Go/NoGo criteria and the corresponding operating characteristics.
