What are the DAC Best Practices?

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

Created with Raphaël 2.1.2
Created with Raphaël 2.1.2

Design, Analyze and Communicate effectively

The DAC Best Practices may be applied in the Design, Analysis, and Communication 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.

DAC Best Practices help facilitate a dialogue between PI teams and other clinical study stakeholders and bring focus to opportunities to improve studies and trials. They can also be used to educate the next generation of PIs and global health partners about current clinical study methods, tools, and resources.

DAC Best Practice Definitions

1. Prioritize disease burden and epidemiology as criteria for study site selection
2. Use accepted and validated endpoints whenever possible
3. Proactively map study outcome to immediate or ultimate policy impact
4. Rigorously justify effect estimates and prevalence assumptions
5. Simulate trial to ensure right sample size and optimal design
6. When feasible and relevant, apply adaptive, pragmatic, platform, or other innovative clinical trial designs
7. Analyze real world evidence to optimize study investments, objectives, and feasibility
8. Prior to study initiation, complete a prospective, fixed statistical analysis plan
9. Design interim analyses with decision rules for stopping for success or futility early enough to reduce the number of participants subjected to ineffective interventions
10. When appropriate, use model-informed drug development, such as PK/PD modeling
11. Adhere to appropriate standards of randomization, blinding, allocation concealment, and reducing bias
12. Use staff with experience in the therapeutic area being studied
13. Implement a real-time data analysis capability, toward improved monitoring of recruitment targets, data quality, and other metrics
14. Engage local regulators, ethics committees and policymakers before, during, and after the study, for input on design, obtaining relevant approvals, and action at study’s end
15. Implement a communication plan and informed consent that involves participants, families, communities, and health systems
16. Publish protocol, analysis plan, and study results, including raw study data and code, in an open access resource, regardless of study outcome

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.

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