NIA Multi-site Clinical Trial Implementation Grant

NIA is strongly committed to identifying effective treatments and preventative interventions for diseases and conditions associated with aging by supporting high-quality, meritorious, mission-relevant clinical trials. Trials in older adults face complex ethical, safety, and methodological issues. Among adults 65 to 84 years of age and those older than 85 years, about 65% and 80%, respectively, have been diagnosed with several chronic conditions, and more than a third of this population is taking five or more prescription drugs. Both multimorbidity and polypharmacy significantly increase risk for unexpected disease-disease and drug-disease interactions. In addition, older adults often have difficulties understanding study details, and special measures should be taken to ensure that they give truly independent and informed consent to participate in research studies. This NOFO provides a vehicle for submitting investigator-initiated grant applications to conduct multi-site clinical trials of all phases and stages on topics relevant to NIA’s mission.

Multi-site clinical trials submitted in response to this NOFO should contribute to the evidence base for important health matters of relevance to NIA’s research mission. For information about the NIA’s mission, scientific research programs, and priorities, please visit the NIA website. Proposed studies must meet the definition of a clinical trial as defined by NIH as: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” See more at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html.

It is expected that NIA-funded clinical trials are not unnecessarily duplicative of previously conducted trials; are appropriately designed and adequately powered to answer the research questions posed; and can be completed within the time limits of this NOFO. It is important that the trials are efficiently conducted by appropriately trained investigators and supported by an award mechanism and terms of award that optimize quality and the likelihood of successful outcomes by promoting the appropriate level of oversight by NIA. Finally, it is crucial that the trials’ findings, whether positive or negative, are published in a timely fashion and available to the scientific community to guide future research directions.

All clinical trial planning activities must be completed prior to the time of application submission and investigators must be ready to implement the proposed trial at the time of award.

If proposing a clinical trial with a single site, please submit to the NIH Parent Announcement: PA-20-183 Research Project Grant (Parent R01 Clinical Trial Required).

Clinical Research Operations Management System: NIA supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of CROMS data templates as specified.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.