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
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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.
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At least 3 clinical trials should stratify participant risk groups using dense "omics" and gene-environment interaction profiling.
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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
- RFA-AG-13-015: Alzheimer's Disease Prevention Trials (R01)
- RFA-AG-17-064: Pragmatic Trials for Dementia Care in Long-term Services and Support (LTSS) Settings (R01)
- RFA-AG-18-031: Towards Implementing Novel Training Methods to Enhance Cognition in Aging (U01)
- RFA-AG-19-009: NIA AD/ADRD Health Care Systems Research Collaboratory (U54)
Research Programs and Resources
- Dominantly Inherited Alzheimer's Network Trials Unit - Adaptive Prevention Trial (DIAN-TU)
- Closing the Gap between Observational Research and Randomized Trials for Prevention of Alzheimer’s Disease and Dementia
- NIA IMPACT Collaboratory: Transforming Dementia Care
- Pragmatic Trials to Improve Care and Outcomes for Persons with Dementia in Long-Term Care