Best Practices for Informativeness in Clinical Research
This series of informative videos presented by global experts provide detail on each of the DAC Best Practices. Find out more about what the Best Practices are, why are they important, and how implementing them can help you deliver an informative study. The following resources are split into the three DAC aspects – Design, Analyze and Communicate.
D(A)C – Analyze aspects
7. Analyze real world evidence to optimize study investments, objectives, and feasibility (click thumbnail to play)
D(A)C – Analyze aspects
8. Prior to study initiation, complete a prospective, fixed statistical analysis plan (click thumbnail to play)
D(A)C – Analyze aspects
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 (click thumbnail to play)
D(A)C – Analyze aspects
10. When appropriate, use model-informed drug development, such as PK/PD modeling (click thumbnail to play)
D(A)C – Analyze aspects
11. Adhere to appropriate standards of good clinical practice, including a focus on monitoring participant safety and study integrity (click thumbnail to play)
D(A)C – Analyze aspects
12. Use staff with experience in the therapeutic area being studied (click thumbnail to play)
D(A)C – Analyze aspects
13. Implement a real-time data analysis capability, toward improved monitoring of recruitment targets, data quality, and other metrics (click thumbnail to play)
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.
