Notice Number: NOT-AG-15-018

Key Dates
Release Date: September 24, 2015
Response Date: May 9, 2016

Issued by
National Institute on Aging (NIA)

Purpose

The Division of Geriatrics and Clinical Gerontology (DGCG) at the National Institute on Aging (NIA) supports clinical trials on topics relating to aging and the elderly. Researchers with interest in trials whose direct costs are less than $2 million per year are encouraged to contact the Clinical Trials Branch staff at [email protected].

DGCG also invites suggestions from the scientific community regarding needs for large (over $2 million direct and/ or over $3 million total costs per year) clinical trials in topic areas relevant to DGCG’s mission. NIA/NIA DGCG will use your suggestions in its planning process to select high priority topic areas in which significant existing knowledge indicates the need for large clinical trials to provide more definitive information on risks and benefits of interventions for diseases and conditions in the elderly.

Background

The DGCG supports research on health and disease in the aged as well as research on aging over the human life span including its relationships to health outcomes. DGCG comprises three major research areas: Geriatrics, Clinical Gerontology, and Clinical Trials. The Geriatrics Branch primarily focuses on health issues regarding the aged. The Clinical Gerontology Branch focuses on clinically-related issues regarding aging changes over the life span. The Clinical Trials Branch plans and administers clinical trials on age-related issues with emphasis on:

- Interventions to prevent or treat “geriatric syndromes”, disability, and complications of comorbidity or polypharmacy;
- Trials to detect age- or comorbidity-related differences in responses to interventions against conditions found in middle age and old age;
- Interventions for problems associated with menopause and other mid- and late-life changes
Interventions that may affect rates of progression of age-related declines in function in early and midlife;
- Interventions with protective effects against multiple age-related conditions.

More information about DGCG is available at http://www.nia.nih.gov/research/dgcg.

Information Requested

Your suggestions will assist the DGCG in planning for large scale clinical trials in topic areas relevant to its mission where existing evidence suggests the need for definitive information about the benefits and risks of interventions for diseases and conditions in the elderly.

Suggestions can include but are not limited to the following issues:
1) The topic area and current state of science indicating the need for a large scale clinical trial or trials to obtain definitive information about the benefits and/or risks of intervention or interventions in elderly in the topic area;
2) The prospective study population and a potential intervention or interventions and any preliminary information supporting the need for testing such an intervention or interventions in a large scale trial in the proposed population. Drugs, devices, lifestyle modifications, and other interventions could be proposed;
3) Rationale for the selection of endpoints (clinical, functional, or surrogate). There is no need to propose specific outcome measures;
4) Estimation of sample size, duration and costs of trial(s); and
5) Any additional comments or suggestions that you think would be useful.

Submit a Response

Please respond no later than May 9, 2016. We look forward to your suggestions and hope you will share this RFI with your colleagues.

The information provided in response 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 in general, the NIH or NIA specifically. NIH does not intend to make any awards based on responses to this RFI or to pay for the preparation of any information submitted or for the Government’s use of such information.

Inquiries

Please direct all inquiries to:

Sergei V. Romashkan, M.D., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-435-3047
Email: [email protected]