Here’s a new funding opportunity that might interest you.
The support is for a clinical trial on reducing chronic inflammation. I’m the program officer for this area, and I’d like to tell you a bit more about it. I particularly wanted to write this blog because this new funding is through the U01 mechanism, and not everyone is familiar with exactly how that works. And, the deadline for the letter of intent is coming up next month, so I urge you to get in touch and start writing!
Where is this new funding for inflammation coming from?
The NIA Division of Geriatrics and Clinical Gerontology—the part of the NIA that I work for—supports research on health and disease in older people and research on aging over the human lifespan. That includes how aging relates to health and functional outcomes. The Division of Geriatrics and Gerontology comprises 3 major research areas, administered by its three Branches—Geriatrics, Clinical Gerontology, and Clinical Trials. This funding opportunity announcement is coming from our Clinical Trials group.
Why do we care about inflammation?
Low-grade chronic inflammation increases with aging, and growing evidence links it to risk of chronic diseases, such as cardiovascular disease, type 2 diabetes, dementia, and cancer, as well as with conditions such as frailty, functional decline, and disability in activities of daily living. But, it’s not clear whether inflammation actually causes these conditions. Clinical trials to date on the role of anti-inflammatory medications have given us only limited evidence on whether reducing inflammation prevents or treats specific diseases. They have not focused on functional outcomes, particularly in high-risk populations.
What kind of research will this new opportunity support?
NIA recently released a new Request for Applications: Clinical Trial on the Effects of Interventions Aiming to Reduce Chronic Inflammation in Older Adults: Pilot Phase (U01).
We are offering this funding opportunity to encourage research on the effect of chronic low-grade inflammation on functional outcomes in older people. The goal of the initial, pilot phase is to generate preliminary data to inform decisions about the design of a possible clinical trial (or trials) in the second, clinical trial phase.
In the pilot phase, investigators can assess the feasibility of specific design options, such as eligibility criteria, choice of intervention(s), study outcomes, and safety. This includes secondary analyses of relevant data and biospecimens.
The decision to issue the funding opportunity announcement for, and to fund, the second, clinical trial phase will depend on meeting the objectives of the pilot phase and on the availability of funds.
What is a U01, and why aren’t you offering an R01 instead?
At the NIH, U01 funding is used when an NIH Institute anticipates substantial programmatic involvement in the planning and implementation of the project. As you know, that’s not the case with R01s. So, we at the NIA plan to be really involved in this inflammation grant. Our involvement often helps when different study sites need to be coordinated or the study requires more planning and consultation than a typical R01 research project.
What is the main outcome measure?
The primary functional outcome is mobility disability, measured by performance on a walk test. We chose this measure based on the importance of mobility to independent living among older people, and on consistent findings of a correlation between elevated inflammatory markers and impaired mobility. Thus, the target population will be older individuals at risk for, or with, mobility impairment as measured by slow gait speed, and with elevated levels of inflammatory markers.
What is the funding period for this award?
One award will be made under this funding opportunity announcement. The pilot phase will be funded for up to 3 years.
What is the goal of the clinical trial phase, which may occur later?
The objective would be to conduct one or more clinical trials on the effects on mobility (as measured by gait speed) of one or more anti-inflammatory agents, compared to placebo. The trial would be conducted in older people with elevated inflammatory markers and at risk for, or with, mobility impairment. A closely related objective would be to examine the safety of reducing chronic low grade inflammation in the target population.
If it goes forward, the clinical trial funding opportunity announcement will appear separately in the future.
What is the deadline for applications?
The deadline for letters of intent is September 8, 2014. The deadline for applications is October 8, 2014.
For more information, please see RFA-AG-15-006. Questions and comments applicable to many applications may be addressed in the comments, below. If you have questions specific to your individual application, please get in touch with me directly or the other scientific contacts listed in the RFA.