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NIA Division of Geriatrics and Clinical Gerontology Policies Regarding Investigator-Initiated Applications for Large Clinical Trials

Funding Number: NOT-AG-11-009
Funding Type: NOT
Release Date: September 7, 2011
Expiration Date: January 1, 2019
Web Site: http://grants.nih.gov/grants/guide/notice-files/NOT-AG-11-009.html
NIA Division Geriatrics Clinical Gerontology Policies Regarding Investigator-Initiated Applications Large Clinical Trials Notice Number: NOT-AG-11-009 Key Dates Release Date: September 7, 2011   Issued National Institute Aging NIA) Purpose Notice to inform potential applicants changes policies regarding proposals large clinical trials seeking support NIA’s Division Geriatrics Clinical Gerontology DGCG). Background DGCG one four NIA extramural research program divisions. Information the range research areas addressed DGCG available the NIA website http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/Geriatrics....  Prior this Notice, DGCG not accepted applications investigator-initiated clinical trials whose direct costs NIA exceed 2M per year.  Effective September 1, 2011, DGCG consider acceptance such applications, subject the policies procedures, described below. Revised Policies Procedures Investigators considering submitting applications clinical trials which support through DGCG desired, whose direct costs NIA exceed 2 million any project year, asked are required) send brief concept proposal, describing rationale the trial its aims, design, costs DGCG staff designated the end this Notice.  sample Proposal Concept Form provided http://www.nia.nih.gov/ResearchInformation/CTtoolbox/. DGCG accept formats provided contain relevant information. DGCG staff consider proposal concept its relevance the NIA mission its cost. Staff inform investigators proposing trial concept whether will refer to DGCG's Clinical Trials Advisory Panel CTAP), subcommittee NIA’s National Advisory Council Aging, advice regarding relevance the NIA mission public health significance. After receiving CTAP's advice the concept, NIA consider in annual planning process resource allocation. DGCG notify investigators proposing trial concept its decision whether not accept application the full-scale trial. Applications large clinical trials should include evidence prior planning a detailed draft protocol. Such planning be supported the R34 planning grant mechanism http://grants.nih.gov/grants/guide/pa-files/PA-09-186.html), from sources.  Investigators proposing trial, who not advanced planning the point preparing detailed protocol, who wish know whether not NIA accept application such trial before engage this degree planning develop R34 application, submit concept proposal the trial, described above. Such concept proposals be considered DGCG staff CTAP described above. DGCG staff notify investigators proposing trial concept the results this consideration. Investigators thus defer decisions whether not develop detailed protocol develop R34 application until receive feedback DGCG staff. Regardless contact DGCG staff, investigators submit applications R34 planning grants clinical trials any size. However, DGCG decisions funding such R34 applications be influenced its decisions whether not would accept application the full-scale trial be planned. above procedures investigator-initiated applications large trials not replace, rather supplement, existing DGCG procedures planning issuing DGCG FOAs clinical trials, including investigator-initiated concepts proposed FOAs.  procedures submitting R34 applications potential investigator-initiated trials, described detail NIA’s website http://www.nia.nih.gov/ResearchInformation/CTtoolbox/. Inquiries Please direct inquiries to: Sergei V. Romashkan, M.D., Ph.D. Chief, Clinical Trials Branch Geriatrics Clinical Gerontology Program National Institute Aging 7201 Wisconsin Avenue, Suite 525A Bethesda, MD 20892-9205 Fed Ex Packages ZIP 20814) Phone: 301-435-3047 Fax: 301-480-1066 romashks@nia.nih.gov