All Times EDT
Keywords: Go/No-Go, Decision Making
During the course of the development of a new compound there are multiple decision points. Key points are among others the decision to move forward with a compound during early development and the decision to proceed with a compound into phase 3. The former focuses on the design of reasonably sized early trials in order to detect activity signals that provide assurance to move forward or stop development based on pre-defined criteria. The latter will consider also the probability to achieve an outcome, i.e. probability of success, that leads to marketing authorization and commercialization based on a clinically meaningful benefit.
Decisions are multifactorial, considering eg clinical data, portfolio considerations, future costs and differentiation in the competitive landscape; although the components of the decision process are not new, it remains a continuous challenge. Quantitative frameworks have been developed and are used in clinical development to support an evidence-based decision process when designing clinical trials and making investment decisions across a portfolio in a consistent manner.
This presentation will address the principles of good decision making and present frameworks based on multiple possible outcomes with special focus on an adaptation of a method initially introduced by Lalonde, that is used at AstraZeneca. It will outline, from a medical development perspective, some important considerations for defining decision criteria, as well as the required interactions in the cross-functional development team, experiences and future trends.