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Milestone 10.D

Create new research programs to implement innovative trial designs with a precision medicine research paradigm. These efforts should include support for the development of novel statistical approaches (e.g., Bayesian methods, modeling, and simulations) for more efficient trial design and resources to evaluate the utility of intermediate, prognostic endpoints and platform trials such as umbrella, basket, etc.


Success Criteria

  • Launch at least 6 clinical trials using innovative trial designs such as adaptive trial design, functional challenge studies, pragmatic clinical trials, population-based cohort designs, and clinical trial/population-based cohort hybrid designs.

  • At least 3 clinical trials should stratify participant risk groups using dense "omics" and gene-environment interaction profiling.

  • Support administrative data linkages with EHR and private payer claims data.


Research Implementation Area
Trial Design
Timeline
2017–2023
Status
In Progress

Accomplishments/Implementation Activities

Funding Initiatives

Research Programs and Resources

Research Highlights

Relevant Recommendations