Request for Information (RFI): Large Scale Clinical Trials in the Elderly

Notice Number: NOT-AG-08-002

Key Dates
Release Date: April 1, 2008
Response Due Date:  July 1, 2008

Issued by
National Institute on Aging (NIA), (


The Geriatrics and Clinical Gerontology Program (GCG) at the National Institute on Aging (NIA) invites comments and suggestions from the scientific community regarding needs for large (over $2 million direct costs per year) clinical trials in topic areas relevant to GCG’s mission.  NIA will use these comments and 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.


The GCG 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. GCG 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:

More information about GCG is available at


Your suggestions and comments will assist the GCG 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.

Please provide comments and suggestions addressing the following issues.  However, the information presented need not to be limited to these areas.

1.  Provide a brief description of 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.  Define the prospective study population and briefly discuss 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.  Provide a brief rationale for the selection of endpoints (clinical, functional, or surrogate). There is no need to propose specific outcome measures.

4.  Briefly discuss public health significance of the proposed trial or trials.

5.  Provide an estimate of sample size, duration and costs of trial(s).

6.  Provide any additional comments or suggestions that you think would be useful.


Responses in any of the areas are welcome; you do not need to address all items.  Please respond no later than July 1, 2008.  We look forward to your suggestions and comments, and hope you will share this document with your colleagues. 

This RFI shall not be construed as a solicitation for applications or as an obligation on the part of the government. The government will not pay for the preparation of any information submitted. Responders should be aware that the information provided will be analyzed and may be used to developing future funding opportunity announcements.  The government cannot guarantee the confidentiality of the information provided.


To respond, please send a letter, fax, or email to the following address:

Sergei V. Romashkan, M.D., Ph.D.
Chief, Clinical Trials Branch
Geriatrics and Clinical Gerontology Program
National Institute on Aging
Gateway Building, Suite 525A
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
(Fed Ex Packages use ZIP 20814)
Phone: 301-435-3047
Fax: 301-480-1066

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