The NIH’s National Institute on Aging (NIA) wants to hear from the research community regarding needs for large (over $2 million direct and/or over $3 million total costs per year) clinical trials on topics related to aging and the elderly. Suggestions will be used to help select high priority research areas that would greatly benefit from such trials to determine risks and benefits of treatments for conditions in the elderly.
The Division of Geriatrics and Clinical Geronotology (DGCG) within the NIA comprises three research areas: geriatrics, clinical gerontology, and clinical trials. The clinical trials branch is responsible for planning and administering clinical trials on age-related research with a focus on interventions including those to prevent disability, address problems associated with menopause, slow rates of age-related declines in function in early and midlife, and more. Suggestions to assist the DGCG in planning these clinical trials can include but are not limited to:
- 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 risks of intervention or interventions in elderly in the topic area;
- The prospective study population and 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;
- Rationale for the selection of endpoints (clinical, functional, or surrogate). There is no need to propose specific outcome measures;
- Estimation of sample size, duration and costs of trial(s); and
- Any additional comments or suggestions that you think would be useful.
Please submit comments no later than May 9, 2016. See full announcement for further details and instructions.