NOT-AG-04-008: Notice on NIA Policies Regarding Acceptance of Applications for Clinical Trials

Department of Health
and Human Services (HHS)

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Notice on NIA Policies Regarding Acceptance of Applications for Clinical Trials

Notice Number: NOT-AG-04-008

Key Dates
Release Date: September 8, 2004

Issued by
National Institute on Aging (NIA), (http://www.nia.nih.gov/)

The National Institute on Aging (NIA) supports clinical trials on a variety of topics. Criteria by which the NIA decides to accept or decline clinical trial applications after they have been received include the following:

Importance of the research hypothesis to the mission of the NIA
Potential impact that the proposed trial will have on public health, clinical practice, or providing important new information to practitioners and consumers
Overlap or duplication of other clinical trial activities, including similarities to ongoing or recently concluded trials
Feasibility
Cost (Please also review the following web link for NIH policies pertaining to applications requesting direct costs of $500,000 or more for any year.) http://grants.nih.gov/grants/guide/notice-files/not98-030.html

These criteria apply to applications for Phase 1, Phase 2, and Phase 3 trials, with budgets at any level.

Particularly since potential applicants may not be aware of ongoing similar or identical studies if no reports from these studies have been presented or published, persons considering submission of an application for a Phase 1, 2, or 3 clinical trial in a research area administered by NIA are strongly encouraged to contact one of the following program staff listed below, well in advance of the date that they would wish to submit an application.

General information on NIA research areas may be found on the NIA website: http://www.nia.nih.gov/ under Research Programs (Extramural Programs). However, this information is not exhaustive and does not provide information on specific studies, which can be provided by the following staff:

NIA Staff Contacts:

Behavioral and Social Research Program:

Anneliese Hahn, M.S.
Gateway Building, Suite 533
National Institute on Aging
Bethesda MD 20892-9205
(301) 594-2138
[email protected]

Geriatrics and Clinical Gerontology Program:

Joanna Badinelli, M.Ed.
Gateway Building, Suite 525A
National Institute on Aging
Bethesda MD 20892-9205
(301) 435-3046
[email protected]

Neuroscience and Neuropsychology of Aging Program:

Neil Buckholtz, Ph.D.
Gateway Building, Suite 350
National Institute on Aging
Bethesda MD 20892-9205
(301) 496-9350
[email protected]

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