Principles and approaches for research methods to Design, Analyze, Communicate (DAC) clinical studies.
The purpose of this tool is to enable a rigorous and standardized review and subsequent discussion by study teams to enhance the probability of carrying out an informative study. Consider the DAC Best Practices when discussing your answers.
Best Practices
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 intervention
10. When appropriate, use model-informed drug development, such as PK/PD modelling
11. Adhere to appropriate standards of good clinical practice, including a focus on monitoring participant safety and study integrity
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
Analyze aspects
33. Provide your statistical analysis plan (draft, if not finalized) for the study including the method for subject allocation, measurement methods of response variables, hypothesis to be tested, analytical approach to common problems including early study withdrawal and protocol violations. Please describe your plans to analyze and report disaggregated data by gender, including data for withdrawals or dropouts.
34. Describe your interim analysis plans including decision rules/stopping rules, possible outcomes, and statistical adjustment considerations. Will there be criteria to stop for futility or efficacy? If not, please explain the rationale. Please describe any pre-planned adjustments to the study design (e.g., adaptive designs) and operating characteristics of the decision rules related to the adaptive elements of the design.
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.
