What is the DAC Approach?
The DAC approach includes the following tools and activities:
Study concept
1. Learn about the DAC Best Practices
DAC Best Practices are robust clinical study methods made available for design, analysis, and communication that make it more likely that studies will yield informative outcomes.
DAC Best Practices help facilitate discussion around important aspects of study planning and bring focus to opportunities to improve studies and trials. Implementors of studies should also always refer to relevant regulatory standards and guidelines (e.g. FDA, EMA) to assist with study/protocol design.
2. Complete the DAC Assessment Tool
The DAC Assessment Tool (DAT) is a questionnaire which may be completed by principal investigators (PIs) as they plan their study. The DAT questions reference all the DAC Best Practices and help PIs think about their study plans in a different way.
Ask the right question(s) using accepted endpoints and simulation tools to explore the performance of different designs.
Plan statistical and interim analyses, incorporate decision rules and apply model-informed drug development.
Engage and communicate with key stakeholders before, during, and after the study.
The completed DAT serves as a diagnostic guide to help PIs and other stakeholders assess whether a proposed study plan is likely to provide definitive answers and lead to implementable results. By relating the completed DAT to the DAC Best Practices, the strengths, weaknesses, and gaps of a study can be identified so the study team can address any missed components.
Tools & Resources
What skills, training, or input do you require to implement the DAC Best Practices in your study?
Access the Tools and Resources page to locate training, tools, and resources.
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.