The Clinical Trials Branch (CTB) plans and administers larger-scale and some medium-scale clinical trials on age-related issues that require extensive specialized clinical trials expertise. Trials are ranging in size from 100 to 19,000 participants, with many studies being Phase II trials. Examples of interventions for trials include:
For more information about select DGCG-funded clinical trials or if you are interested in participating in these studies, visit their websites:
In collaboration with other NIA Divisions, the clinical trials branch develops and makes available to the research community informational and education resources to ensure safety of participants and high quality of data collected in NIA-funded trials. These resources include the NIA Clinical Research Toolbox and NIA Safety Training Course. The NIA Clinical Research Toolbox is an information repository that contains templates, sample forms, guidelines, regulations and information materials to assist investigators in the development and conduct of high quality clinical research studies. The Safety Training Course provides guidance on responsibilities regarding the fundamentals of safety surveillance and reporting in clinical trials funded by the National Institute on Aging.
There are several funding mechanisms available through CTB to provide support for your clinical trial. Smaller and medium size investigator-initiated trials are usually supported using 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 http://grants.nih.gov/grants/funding/submissionschedule.htm.
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 email@example.com 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 http://grants.nih.gov/grants/funding/submissionschedule.htm.
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. (http://grants.nih.gov/grants/guide/notice-files/NOT-AG-11-009.html). 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 the elderly. Using the Initial Proposal Concept Form (found in the Startup section of the Toolbox) or any other format, please provide to firstname.lastname@example.org your suggestions addressing the following issues: