This FOA is the result of ongoing efforts by the NIAMS to continually evaluate and improve upon existing programs. Based on internal review, along with the advice of an externally convened Centers Evaluation Working Group (CEWG) and a Request for Information (RFI) that followed, the NIAMS decided that the traditional Multidisciplinary Clinical Research Centers (MCRC) (i.e., P60), originally established in 2001 to promote clinical, epidemiological, and health-services research, needed to be updated. This FOA represents such changes and offers a unique opportunity to advance the methodological sciences that support clinical research within and across the NIAMS’ portfolio of diseases.
The NIH definition of clinical research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator or colleagues directly interact with human subjects, including epidemiological or behavioral studies and outcomes research and health services research. The focus of this FOA is on clinical research that ultimately, directly or indirectly, impacts upon patient care to make a difference. Ideally, applications submitted in response to this FOA should build on emerging thinking and innovative ideas, such as the surge in ‘omics’ data, enabling these new approaches to ultimately, meaningfully improve health-related outcomes for patients with skin, musculoskeletal, or rheumatic diseases or conditions.
By design, the NIAMS CCCR are to consist of a strong methodologic core and a more modest administrative research core focused on the support of clinical research. The inclusion of optional additional Resource Core(s), focused on the mission of the CCCR, is encouraged. CCCR PD/PIs have the flexibility to organize the center activities around a central scientific theme or to organize the center activities with more traditional approaches. These CCCRs are envisioned to be flexible, innovative and adaptable, allowing for dynamics in the design, structure, and conduct of the individual components. They are intended to be able to accommodate and address the most pressing needs of the NIAMS clinical research community while keeping in mind existing and/or projected gaps in knowledge, breadth of concepts, and issues of feasibility and adoptability. This FOA will not support core centers (or activities within centers) focused on the generation of biological or genetic data or the development of novel technologies for such generation.
Applicants for CCCRs are encouraged to develop cross-disciplinary resources and are encouraged to leverage available existing resources (e.g., CTSAs) in order to harmonize institutional support for this clinical science, and to advance the goals and objectives of the proposed center. Translating discovery into improved health will require use of optimized, state-of-the-art methodologies (e.g., propensity score matching) and analytics in order to usher in ground-breaking, paradigm-shifting research. For example, by addressing common themes these research cores could contribute toward converting big data into personalized data and thereby inform as well as transform future clinical care. The proposed CCCRs should in some way include efforts addressing the preferences and needs of patients and to include these at all levels of clinical research from conceptualization to implementation. Success will be based on addressing substantial common unmet clinical needs from the perspective of all stakeholders (patients, providers or researcher) and answering important clinical and methodological questions in the NIAMS’ portfolio of diseases.
In contrast to prior NIAMS-funded MCRC (P60) FOAs, this FOA will not allow submission of research projects; only cores (P30). Applicants may propose the inclusion of an optional program for Pilot and Feasibility (P&F) studies that would support the goals of this FOA by presenting an initial proof-of-concept and/or contributing to the robust premise for clinical research.
Required elements of a CCCR include:
- A CCCR program for diseases and disorders within the NIAMS mission that would be supported by either 1) a meritorious clinical research base that encompasses specific diseases or conditions (traditional disease focused) or 2) professional and patient-derived resources for developing future clinical projects and improving patient care (theme focused).
- An overall CCCR Director and Associate Director with outstanding credentials for promoting clinical research, clinical trials and/or patient care implementing innovative methodologies.
- An Administrative Core that will 1) play a key role in providing support for innovative and multidisciplinary approaches for clinical projects within the NIAMS mission; 2) contribute to the clinical training environment of the CCCR and 3) attract new investigators into clinical research within the NIAMS mission. The Administrative Core will engage members for an External Advisory Committee to the CCCR, and organize and convene meetings of this body to obtain administrative and scientific input.
- A Methodologic Core that would facilitate the development and implementation of clinical research by providing expertise and support to new and ongoing local projects and other emerging research opportunities elsewhere that are relevant to the NIAMS mission. The Methodologic Core may support outcomes research, epidemiology, clinical trials and /or health services research. While this core is not required to be innovative, it should be “state-of-the-arts” and drive innovation within the clinical research community. Methodologic Cores may play broader roles in more traditional-focused relative to theme-focused centers. However, the incorporation of novel methodologies such as molecular phenotyping of patients for clinical trials or novel uses of biomarkers for patient selection, could be considered with either approach.
Optional elements of a CCCR include:
- A plan for up to two Pilot and Feasibility projects supported by the CCCR, if proposed, should be included in the Administrative Core with a yearly budget of at least $20,000 and up to $50,000 in direct cost per year and lasting no more than three years.
- Additional Resource Core(s) focused on clinical research areas that significantly contribute to the focus of the CCCR and provide innovative support and methodologies to the research community.
Deadline: January 17, 2017; January 17, 2019 (full proposals); letters of intent are due 30 days prior to the application due date.
Filed Under: Funding Opportunities