Frequently Asked Questions: About DAC

Design, Analyze, Communicate: Working together to improve clinical study outcomes.

1. What is DAC?

Design, Analyze, Communicate (DAC) is BMGF’s new program designed to offer their grantees a set of tools and resources to design, analyze, and communicate clinical studies optimized for an informative outcome with the intention of creating informative clinical studies.

Though initially developed for BMGF grantees, DAC’s tools and resources constitute a public good. BMGF has established this DAC Knowledge Hub to make the DAC public goods broadly available to benefit global health clinical research. For more information click here.

DAC focuses on three critical areas of study planning 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.

2. Why is DAC needed?

Clinical studies represent a significant investment and provide vital information needed to achieve global health impact. However, data show that not all trials provide robust answers to the questions asked.
Poor design can lead to uninformative study results and ultimately to bad decision-making, wasted resources, and the erosion of trust between study investigators and subjects.

Creating informative clinical studies often requires a team of technical specialists across a broad range of skills. Many PIs, especially those located in LMICs, lack access to the diversity of technical expertise needed to run today’s complex studies. BMGF implemented DAC to assist PIs with their review of proposed study plans and receive trial planning grants to address gaps identified in study planning. DAC’s goal is a standard of excellence in study planning so that study results may provide the greatest impact in the shortest time using the least amount of resources. For more information click here.

3. What is the DAC Assessment Tool?

The DAC Assessment Tool (DAT) includes questions across a broad area of topics for the study team to consider when designing informative studies. PI teams complete the DAT, which prompts them to think about their study plans in a different way.

The tool is composed of a list of important elements that may be considered in the design, analysis, and communication (DAC) of clinical studies (regardless of the stage of development of the medicine or intervention). While not all points are relevant to all studies, in general they are intended to promote sound and proven scientific methodology combined with the use of recent innovations in trial design.

To find out more and access the DAC Assessment Tool click here.

4. What are the DAC best practices?

DAC best practices are clinical study best practices that may make studies more informative. They are important because:

If implemented successfully, they may increase the likelihood of informative results.
They can be used to educate PIs and study teams in current clinical study best practices.
They help facilitate discussion around important aspects of study planning and bring focus to opportunities to improve studies and trials.

To find out more and to access the DAC Best Practices click here.

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.