What are the DAC Best Practices?
Design, Analyze and Communicate: Working together to improve clinical study outcomes.
The DAC Best Practices focus on three critical areas of study planning that affect overall study informativeness:
Design
Ask the right question(s) using accepted endpoints and simulation tools to explore the performance of different designs.
Analyze
Plan statistical and interim analyses, incorporate decision rules and apply model-informed drug development.
Communicate
Engage and communicate with key stakeholders before, during, and after the study.
DAC Best Practice Definitions
Please note: Implementors of studies should also always refer to relevant regulatory standards and guidelines (e.g. FDA, EMA) to assist with study/protocol design.