Request for Information (RFI): Large Scale Clinical Trials on Aging

Notice Number: NOT-AG-12-018

Key Dates
Release Date: December 17, 2012
Response Date: September 3, 2013

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 research topics relating to aging and the elderly.  Researchers with interest in clinical trials with direct costs less than $2 million per year are encouraged to contact the NIA DGCG Clinical Trials Branch staff at gcgquery@mail.nih.gov.  

NIA 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 on research topics relevant to NIA DGCG’s mission.  NIA DGCG may use the suggestions in its comprehensive planning process to identify and select high-priority research topics in which significant current 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

NIA DGCG supports research on health and disease in the aged as well as research on aging over the human life span, including relations between aging and numerous health outcomes.  NIA 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 changes and conditions associated with advancing age over the human lifespan.  The Clinical Trials Branch plans and administers clinical trials on age-related changes and conditions with an emphasis on:

More information about DGCG is available at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/GeriatricsAndClinicalGerontology/

Information Requested

Your suggestions may assist NIA DGCG in comprehensive planning for large-scale clinical trials in research-topic areas relevant to its mission where current evidence suggests a need for definitive information about the benefits and risks of interventions for diseases and conditions in the elderly.

Please provide suggestions addressing the following issues:

  1. The current state of science indicating a need for a large-scale clinical trial or trials to obtain definitive information about the benefits and/or risks of intervention or interventions;
  2. Prospective study population(s) and potential intervention or interventions and any preliminary information supporting the need for testing such an intervention or interventions in a large-scale trial or trials in the proposed population(s).  Drugs, devices, lifestyle modifications, and other interventions may also be proposed;
  3. Rationale(s) for the selection of endpoints (clinical, functional, or surrogate).  There is no need to propose specific outcome measures;
  4. Estimate(s) of sample size, duration, and costs of trial(s);
  5. Provide any additional comments or suggestions that you think would be useful.

Response and Process

Please email your responses to gcgquery@nia.nih.gov no later than September 3, 2013.  We look forward to your suggestions and hope you will share this document with your colleagues. 

All suggestions will be considered as part of a comprehensive planning process.  This RFI is not a solicitation and any comments and suggestions submitted in response to it do not create and do not constitute an obligation upon the U.S. Government, the NIH, or the NIA.  NIA will not make any awards based on suggestions submitted in response to this RFI.  Furthermore, neither the U.S. Government nor the NIH nor the NIA will pay for any suggestions submitted or for any expenses incurred by those individuals, or the institutions with which the submitting individuals may be associated, in the course of preparing and submitting suggestions in response to this RFI.  Finally, neither the U.S. Government nor the NIH nor the NIA will pay for the use of suggestions submitted in response to this RFI.

Proprietary information, classified, confidential, or otherwise sensitive information should not be included in responses/suggestions to/for this RFI.  NIA will not de-identify information or suggestions submitted in response to this RFI.  The U.S. Government reserves the right to use non-proprietary technical information in any solicitation that may follow.

Inquiries

Please direct all inquiries to:

Sergei V. Romashkan, M.D., Ph.D.
National Institute on Aging (NIA)
7201 Wisconsin Ave., Ste. 525A
Bethesda, MD 20892-9205
Telephone: 301-435-3047
Fax: 301-480-1066
Email: romashks@nia.nih.gov


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