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


Notice Number: NOT-AG-11-009

Key Dates

Release Date:  September 7, 2011  

Issued by

National Institute on Aging (NIA)

Purpose

This Notice is to inform potential applicants about changes in policies regarding proposals for large clinical trials seeking support from NIA’s Division of Geriatrics and Clinical Gerontology (DGCG).

Background

DGCG is one of four NIA extramural research program divisions. Information on the range of research areas addressed by DGCG is available on the NIA website at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/GeriatricsAndClinicalGerontology/.  Prior to this Notice, DGCG has not accepted applications for investigator-initiated clinical trials whose direct costs to NIA would exceed $2M per year.  Effective September 1, 2011, DGCG will consider acceptance of such applications, subject to the policies and procedures, described below.

Revised Policies and Procedures

Investigators considering submitting applications for clinical trials for which support through DGCG is desired, and whose direct costs to NIA would exceed $2 million in any project year, are asked (but are not required) to send a brief concept proposal, describing the rationale for the trial and its aims, design, and costs to DGCG staff designated at the end of this Notice.  A sample Proposal Concept Form is provided at http://www.nia.nih.gov/ResearchInformation/CTtoolbox/. DGCG will accept other formats provided they contain the relevant information.

DGCG staff will consider the proposal concept for its relevance to the NIA mission and its cost. Staff will inform the investigators proposing the trial concept whether they will refer it to the DGCG's Clinical Trials Advisory Panel (CTAP), a subcommittee of NIA’s National Advisory Council on Aging, for advice regarding its relevance to the NIA mission and public health significance. After receiving CTAP's advice on the concept, NIA will consider it in its annual planning process for resource allocation. DGCG will notify investigators proposing the trial concept of its decision on whether or not to accept an application for the full-scale trial.

Applications for large clinical trials should include evidence of prior planning and a detailed draft protocol. Such planning may be supported by the R34 planning grant mechanism (http://grants.nih.gov/grants/guide/pa-files/PA-09-186.html), or from other sources.  Investigators proposing a trial, but who have not advanced in planning to the point of preparing a detailed protocol, and who wish to know whether or not NIA would accept an application for such a trial before they engage in this degree of planning or develop an R34 application, may submit a concept proposal for the trial, as described above. Such concept proposals will be considered by DGCG staff and CTAP as described above. DGCG staff will notify investigators proposing the trial concept of the results of this consideration. Investigators may thus defer their decisions on whether or not to develop a detailed protocol or develop an R34 application until they receive feedback from DGCG staff.

Regardless of contact with DGCG staff, investigators may submit applications for R34 planning grants for clinical trials of any size. However, DGCG decisions on funding such R34 applications will be influenced by its decisions on whether or not it would accept an application for the full-scale trial to be planned.

The above procedures for investigator-initiated applications for large trials do not replace, but rather supplement, existing DGCG procedures for planning and issuing DGCG FOAs for clinical trials, including investigator-initiated concepts for proposed FOAs.  These procedures for submitting R34 applications for potential investigator-initiated trials, are described in detail on NIA’s website at http://www.nia.nih.gov/ResearchInformation/CTtoolbox/.

Inquiries

Please direct all inquiries to:

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


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