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NOT-AG-22-044 - Notice of Intent to Publish a Funding Opportunity Announcement for the National Institute on Aging (NIA) Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) Real-World Data (RWD) Platform Initiative (U54 Clinical Trial Required)

Issued by

National Institute on Aging (NIA)

Purpose

The purpose of this Request for Information (RFI) is to solicit comments and suggestions that the National Institute on Aging (NIA) will consider as it endeavors to establish a Real-World Data (RWD) Infrastructure to transform the Alzheimer’s disease (AD) and AD-related dementias (ADRD) research enterprise.

Background

In 2011, attention to AD took on heightened interest with the passage of the National Alzheimer’s Project Act. The law calls for an aggressive and coordinated national plan to accelerate research on AD/ADRD. The first goal of the plan is to treat and prevent AD and ADRD by 2025, and the National Institutes of Health (NIH) leads research efforts towards the goal. NIH’s AD+ADRD Research Implementation Milestones are a research framework detailing specific steps and success criteria towards achieving goal one of the plan. The focus of this RFI is Milestone 13.Q, which is to support the development of AD/ADRD data and clinical infrastructure and harmonization processes that allow for the integration of health care, formal and informal caregiving, and other care-related data from multiple sources (e.g., electronic health record (EHR), claims, surveys, patient-reported outcomes) to facilitate research on diverse populations of persons living with AD/ADRD in order to improve dementia care outcomes as well as recruitment and retention for clinical trials.

NIA, one of the 27 Institutes and Centers of NIH, is the primary federal agency supporting and conducting AD research. In response to Milestone 13.Q, NIA seeks to develop a concept that leverages RWD to create an infrastructure that fosters AD/ADRD research development and addresses disparities that persist in research participation and representativeness of findings. The Food and Drug Administration defines RWD as data related to patient health status and/or the delivery of health care routinely collected from a variety of sources."

To explore the gaps and opportunities for RWD infrastructures, NIA recently welcomed broad external opinions through a stakeholder workshop convened on May 4, 2022. Through this RFI, NIA seeks further information from stakeholders regarding how a RWD infrastructure can be best established and managed to support research and clinical trials on AD/ADRD treatments and diagnosis, prevention strategies, interventions, services, and supports to improve the quality of life of older adults living with AD/ADRD and their families, caregivers, and communities.

Information Requested

Through this RFI, NIA invites feedback from academia, industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, and other members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership.

Respondents are asked to do the following:

• Suggest methods RWD infrastructures can employ to address current gaps in data availability and quality of research on AD/ADRD through, but not limited to, the following: registries, clinical research networks, clinical trials (including virtual, decentralized, and pragmatic) and research programs.
• Comment on how RWD infrastructures can be best established and managed to address health disparities that impact people living with AD/ADRD.
• Describe potential risks and ethical considerations one should consider when establishing and managing a cloud-based data infrastructure. Elaborate on how such risks and considerations might be addressed. Examples of risk and considerations that one may comment on include, but are not limited to the following: privacy, access, reidentification risk, the digital divide and differential technology accessibility, consenting older adults living with AD/ADRD, and disclosure of actionable findings derived from analysis.
• Share insight on which management, oversight, evaluation structure, and metrics are most useful to track RWD infrastructure progress and implementation.
• Share thoughts on which range of RWD sources (e.g., collections of EHR, administrative and medical claims databases, registries, imaging, sensors, and smartphone data, etc.) and data vendors are most applicable for incorporation into an infrastructure.
• Suggest methods by which various data sources can be housed together through centralized and federated systems, and how federated systems can be leveraged to improve clinical trial recruitment. Suggestions regarding data organization, accessibility, connectivity, acquisition, security, and curation are welcomed.
• Comment on collaborations, teaming plans, and public/private partnerships that would be necessary or useful when establishing and managing an infrastructure.
• Provide comments related to storage, security, privacy, and computational technology that should be considered when establishing and managing an infrastructure.
• Elaborate on how infrastructures can be designed to best support general, virtual, decentralized, and pragmatic clinical trials.
• Describe how infrastructures can be leveraged to improve recruitment and research participant experiences.
• Suggest appropriate objectives and key results (OKRs) for measuring goals and tracking outcomes of the infrastructure along with key performance indicators (KPIs) for assessing success of establishing the infrastructure and measuring its usage and effectiveness.

How to Submit a Response

Responses to this RFI must be submitted via email to NIARWD@nih.gov. Responses must be received by 11:59:59 pm (ET) on October 17, 2022.

Responders are free to address any or all the topics listed above. All submitted information will be reviewed by NIH staff and contractor support personnel. Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law.

The information provided will be analyzed and may appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The NIH may use the information gathered to develop grant, contract, or other funding priorities and initiatives.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government general, the NIH, or NIA specifically. The NIH does not intend to make any awards based on responses to this RFI or pay for the preparation of any information submitted or for the Government’s use of such information.

Inquiries

Please direct all inquiries to:

Partha Bhattacharyya, Ph.D.
National Institute on Aging (NIA)
Phone: (301) 496-3131
Email: NIARWD@nih.gov