Seeking Support for Clinical Trials

There are several funding mechanisms available through the DGCG Clinical Trials Branch to provide support for your clinical trial. Smaller and medium size investigator-initiated trials are usually supported using either an Exploratory/Developmental Research Grant Award (R21) or a Research Project Grant (R01) mechanism. Researchers with well-developed plans for trials whose direct costs are under $500,000 in any year of support may submit applications by the appropriate NIH submission due date.

For trials with direct costs between $500,000 and under $2 million in any year of funding, investigators should contact the Clinical Trials Branch staff at gcgquery@nia.nih.gov and obtain permission to submit such an application. Depending upon NIA's scientific priorities, availability of funds and complexity of the proposed trials, the CTB, at its discretion, may accept or decline to accept an R01 application, or may propose for consideration by the investigators a Cooperative Agreement (U01 or UM1) funding mechanism.

Investigators considering submitting applications for investigator-initiated clinical trials for which support through DGCG is desired, and whose direct costs to NIA would exceed $2 million in any project year should follow procedures described in NOT-AG-11-009 "NIA Division of Geriatrics and Clinical Gerontology Policies Regarding Investigator-Initiated Applications for Large Clinical Trials". Meritorious trials of such size most likely will be funded as Cooperative Agreements.

If you have an idea for a large-scale clinical trial, but don't know how to proceed, we would be happy to discuss the idea with you. Your suggestions will assist the DGCG 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 older adults. Using the Initial Proposal Concept Form (found in the Startup section of the NIA Investigator's Toolbox) or any other format, please provide to gcgquery@mail.nih.gov your suggestions addressing the following issues:

• 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 older adults in the topic area.
• Definition of the prospective study population and brief discussion of 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.
• A brief rationale for the selection of endpoints (clinical, functional, or surrogate). There is no need to propose specific outcome measures.
• An estimate of sample size, duration and costs of trial(s).
• Any additional comments or suggestions that you think would be useful.