Data Sharing: Access to clinical trial data/samples (Milestone 3.D)
Timeline Start - End2018 - 2025
Research Implementation AreaData Sharing and Reproducibility
Enable access to data and associated biosamples and biomarkers from completed, ongoing, and future federally and privately funded clinical trials to clarify the biomarkers’ predictive and theragnostic value, to identify surrogate endpoints, and to advance the understanding of heterogeneity of disease and treatment response.
Provide support to enhance completed and ongoing clinical trials with molecular profiling of minimally invasive specimens (serum, peripheral monocytes, microbiome etc.) and use these molecular signatures as indicators of responsiveness and for disease sub-classification.
Develop standard consenting language, simplified data, and material transfer agreements, and provide support for big data infrastructure to ensure the rapid, widespread and appropriate, use/reuse of data and biosamples.
Align funding incentives across federal and non-federal/private trial sponsors to ensure rapid and broad access to data and associated biosamples and biomarkers from legacy, ongoing and future clinical trials.
Summary of Key Accomplishments
NIA’s Clinical Trials program is implementing a policy that requires the timely sharing of data and biosamples from all NIA-funded, early- and late-stage trials, including registration trials. The sharing of data and biosamples from the A4 Study has led to new insights related to differences in the presence of AD biomarkers among participants from different ethnic and racial groups.
The NIA-supported National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD) hosts biosamples from clinical research studies and provides access to these biological materials to qualified researchers for use in a wide array of research projects.
NIA’s Drug Repurposing funding initiative encourages research that utilizes peripheral fluids biosamples from ongoing, as well as legacy, clinical trials to generate genomic data that can be used to understand the determinants of responsiveness to treatment.
The key accomplishments summary is current as of July 2022.
- RFA-AG-17-005: Alzheimer's Clinical Trials Consortium (ACTC) (U24)
- PAR-18-513: Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01)
- PAR-18-877: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)
- PAR-18-878: Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)
- RFA-OD-19-018: Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33)
- PA-16-259: Inclusion of Mobile/e-Consents for Alzheimer’s Disease Research (Admin Supp)
Research Programs and Resources
- Accelerating Medicines Partnership Alzheimer’s Disease (AMP AD) Biomarkers Project
- Ongoing Alzheimer’s and Related Clinical Trials and Studies
- Alzheimer’s Clinical Trials Consortium (ACTC)
- Alzheimer’s Prevention Initiative (API)
- Anti-Amyloid Treatment In Asymptomatic Alzheimer’s Disease Study (A4 study)
- Dominantly Inherited Alzheimer's Network Trials Unit - Adaptive Prevention Trial (DIAN-TU)
- National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD): Accessing Biospecimens and Data
- The INCLUDE Project
- Clinical Trials to Prevent Alzheimer’s Disease in Down Syndrome
- Clinical Trials Development for Co-Occurring Condition in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33) •
- ADRCs Neuropathology & Biospecimen Resource Locator Tool
- How Researchers Can Tap Into Data and Samples From Alzheimer’s Disease Research Centers