About the DAC Knowledge Hub
Design, Analyze, Communicate: Working together to improve clinical study outcomes.
About the DAC Program
Design, Analyze, Communicate (DAC) is a Bill & Melinda Gates Foundation program to help grantees optimize studies for informativeness and impact. DAC includes an evidence-based catalogue of best practices, assessments, open-source simulation software, and other tools for researchers. Since these approaches and tools can benefit not only Gates Foundation grantees but the broader global health clinical research community, the Global Health Network helped the Gates Foundation launch a publicly available version, the DAC Trials Knowledge Hub.
DAC principles, such as Best Practices for Study Informativeness, are translatable across clinical trials and studies as well as implementation research. Three critical areas of study planning affect overall study informativeness:
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 DAC Trials Knowledge Hub
DAC Vision
“We believe it is the responsibility of sponsors, regulators, IRBs, and physicians to use best efforts to design, analyze, and communicate studies that will generate definitive results, as well as protect subject rights and health. Tools for evaluating designs and protocols are urgently needed to identify solutions that save and improve lives. In the hands of the next generation of researchers, such tools will enable rigorous studies and generate data that will affect policy and practice. DAC can be transformative, not only for identifying life-saving therapies but also for developing research and business innovations that accelerate health and equity for those around the world who need it the most.”
The DAC Trials Knowledge Hub
Though initially developed for BMGF grantees, the DAC tools and approaches may also benefit the broader global health clinical research community.
The DAC Trials Knowledge Hub has been developed to allow researchers to access and learn about the DAC tools and approaches so they can implement them and optimize their own studies for informative outcomes.
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.
