Division of Geriatrics and Clinical Gerontology

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:

• Interventions against common geriatric conditions
• Interventions that may affect multiple outcomes, including trials in older persons with multiple conditions or risk factors that may be differentially affected by treatment
• Interventions for specific conditions whose effects on other coexisting conditions or risk factors have not been adequately evaluated
• Interventions that may improve treatment options for older persons with multiple morbidities or risk factors
• Trials in older persons to determine the value of treatment for conditions or risk factors for which indications for preventive or therapeutic interventions are unclear
• Interventions in young, middle-aged, or older persons that affect risk factors reflecting aging processes
• Interventions that may favorably influence multiple predictors of life span or health span, and aging mechanisms that affect these predictors
• Interventions in high-risk older persons to lessen individuals’ number of risk factors for specific adverse clinical, functional and quality-of-life outcomes

For more information about select DGCG-funded clinical trials or if you are interested in participating in these studies, visit their websites:

• ASPirin in Reducing Events in the Elderly (ASPREE) trial
• Lifestyle Interventions and Independence for Elders (LIFE) Study
• Testosterone Trial
• Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) set of trials

Resources

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.

Interested in seeking support for your clinical trials from CTB?

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 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 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 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 elderly 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.