Notice Number: NOT-AG-12-017
Key Dates
Release Date: November 14, 2012
Response Date: March 15, 2013
Issued by
National Institute on Aging (NIA)
Purpose
The National Institute on Aging (NIA), a component of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services, is seeking input from U.S.-based and international public and private organizations sponsoring or conducting Alzheimer’s disease or other clinical trials and studies regarding strategies for increasing enrollment in Alzheimer’s and related clinical trials.
Background
Alzheimer's disease represents a major public health concern. As many as 5.1 million Americans are estimated to have Alzheimer's disease. Further, due to the aging of the population, this number is predicted to double by 2020 and triple by 2040. Although a few approved drugs can alleviate some of the symptoms of Alzheimer's disease, to date there are no treatments available that can delay the onset or slow the progression of the disease. In light of this looming public health crisis, interest in Alzheimer’s disease is intensifying in a growing number of countries.
The first U.S. National Plan to Address Alzheimer’s Disease (http://aspe.hhs.gov/daltcp/napa/NatlPlan.shtml), released in May 2012, has as its first goal to “Prevent and effectively treat Alzheimer’s Disease by 2025.” To support expanded and accelerated research efforts, including clinical trials, needed to reach this ambitious target, the plan also proactively sets an action objective to “increase[e] enrollment in clinical trials and other clinical research through community, national, and international outreach.” (1.B.3)
“Increased enrollment in clinical trials is crucial for the development of better treatments and ultimately a cure for AD. Participating in clinical trials and other research enables volunteers to access the latest experimental approaches available and provides them with care by clinical research staff. HHS will convene representatives from across the federal government, state and local governments, academic medical research institutions, and the private sector to create an action plan for increasing enrollment in clinical trials, including through the building of registries. The partners will identify approaches and coordination points for these efforts to implement the action plan.”
With this Request for Information (RFI), the NIA is seeking recommendations for actionable strategies to increase enrollment in clinical trials. Comments are sought on the following topics:
- Please describe strategies that should be more widely adopted to enhance participation in Alzheimer’s research among people at different stages of the disease (including pre-clinical), normal controls, those with a family history, racial and ethnic minorities, and others. Please indicate what support and coordination may be needed in the short-term and long-term for these efforts.
- Please indicate the most effective role for government agencies and funders (federal, state, and local) to support and facilitate coordination of Alzheimer’s clinical trial recruitment efforts.
- Please describe how registries can be used to support Alzheimer’s and related clinical trials and studies. Please discuss whether there is a need for a centralized registry and how existing registries and tools might be coordinated and used most effectively.
Submitting your Response
U.S.-based and international public and private organizations sponsoring or conducting Alzheimer’s disease or other clinical trials and studies, who are interested in advising this effort should send their responses to the NIA using the contact information below. Responding to this RFI will not be considered as a commitment to participate in the development or implementation of the action plan. Responses will be publicly available.
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, the NIH, and/or the National Institute on Aging. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government’s use of such information.
Please respond by March 15, 2013 and mark your responses with the RFI identifier NOT-AG-12-017 when responding via email.Inquiries
Please direct all inquiries to:
Jennifer L. Watson, Senior Public Affairs Specialist
National Institute on Aging (NIA)
31 Center Drive, Room 5C27
Bethesda, MD 20892-2292
Phone: 301-496-1752
Email: watsonjl@nia.nih.gov
Website: www.nia.nih.gov/alzheimers
and Human Services (HHS)
