July 22, 2020

On June 9, 2020, the NIAMS Advisory Council considered several concepts.

Concept Clearance

Initiative: Leads Description
New Activity
Exploring New Mammalian Models for Studying Tissue Regeneration Alexey Belkin This initiative aims to promote research exploring new mammalian models with naturally high regenerative capacity such as the African spiny mice or naked mole rat. It is expected to facilitate basic studies focused on the discovery of previously unidentified developmental paradigms and delineation of key cellular and molecular mechanisms that should help provide therapeutic targets for the development of future regenerative therapies. 
Role of Inflammation Resolution in Chronic Inflammatory Diseases within NIAMS Mission Heiyoung Park This initiative promotes research on resolution of inflammation, which is a complex and distinctively coordinated response from the onset of inflammation. Uncontrolled and dysfunctional resolution of inflammation would directly link to chronic inflammation, a common pathogenic element among diseases within the NIAMS core mission. Therefore, unraveling basic, translational, and pre-clinical mechanisms of inflammation resolution would contribute significantly to the understanding of pathogenesis and the development of innovative therapies for chronic inflammatory diseases within the NIAMS mission.
Accelerating Host Gene-Microbiome Interactions Research in NIAMS Core Mission Diseases Ricardo Cibotti Host genetics, (i.e. the description of polymorphism at the level of non-coding risk loci or disease causal genes), and the diversity of the gut and/or the skin microbiome, have both been considered to be important contributing factors to a variety of pathologies. However, they are usually considered as independent contributors, and their synergism is poorly understood. Defining the synergism between the host genetics and the diversity and composition of the microbiome may be key to progress in the understanding of the pathogenesis of many diseases and conditions supported by the NIAMS. This initiative proposes to accelerate research focused on describing how host gene-microbiome interactions may impact diseases and conditions within NIAMS mission.
Evidence, Challenges and Lessons Learned in Clinical Trials of Cell-based Therapies for Knee Osteoarthritis Ted Zheng This initiative proposes a scientific conference to engage a diverse group of stakeholders, including thought leaders in the orthopaedic research and clinical communities, clinical investigators who have conducted or are currently conducting cell-based OA clinical trials, and the FDA to discuss and share knowledge gained through these trials.
Addressing Health Equity in OA Kristy Nicks There is evidence of differential OA treatment outcomes and access to care in diverse populations, which lead to poor health. This concept is a placeholder for development and implementation of recommendations from a “state of the science” workshop of OA that would be similar to but smaller scale than the NIH P2P workshops. The underlying premise of the P2P workshop, which seeks to move a public health issue forward after a detailed, unbiased, evidence-based assessment of the current scientific research, will be followed. The proposed workshop would provide a snapshot of the current issues, particularly surrounding disparities and access to health care. The goal is to identify research gaps/needs that could be addressed in future NIAMS activities. NIAMS intends to implement these activities in collaboration with other NIH Institutes, Centers, and Offices and federal agencies.
Re-Issued Funding Opportunity Announcements
Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers Emily Carifi The purpose of this initiative is to solicit applications for Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers. These Centers promote collaborative basic, translational, and clinical research, and provide important resources that can be used by the national muscular dystrophy research community. The Centers also provide outstanding environments for the training of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy. Furthermore, Center investigators participate in community outreach efforts to increase awareness and convey the importance and implications of their research activities to the patient and advocacy communities.
Core Centers for Clinical Research (CCCR) Aron Marquitz The CCCRs provide avenues to advance the methodological sciences that support clinical research within and across the NIAMS' portfolio of diseases. The overall goals of the CCCR are to advance prevention, diagnosis and treatment of musculoskeletal, rheumatic, and skin diseases by developing and fostering the implementation of novel methods, metrics, and outcome measures that address critical existing and emerging clinical research needs.
NIAMS Clinical Studies Operations Management and Support Contract Shahnaz Khan This initiative will provide essential clinical research operations management, resources and services using a highly skilled contract research organization (CRO) for NIAMS funded clinical research studies. This mechanism allows the Institute to meet its responsibility for providing oversight functions to ensure the safety of participants and quality of data generated from clinical studies it supports.

On September 5, 2018, the NIAMS Advisory Council considered the following BACPAC proposal. NIAMS is moving forward with the initiative for Fiscal Year 2019.

NIH Back Pain Consortium (BACPAC) Research Program

Description:
The NIH Back Pain Research Consortium (BACPAC) is a potential initiative to address opioid addiction. BACPAC is a patient-centric translational research program that will address the need for effective and personalized therapies for chronic low back pain by probing the biomedical mechanisms in a biopsychosocial context using interdisciplinary methods and innovative technologies.

Expected Benefit to the Public Health:
Back pain is a major contributor to the use of opioids in the U.S., however, at present no effective treatment exists that provides long term, sustained relief of back pain and disability for all patients. Further, there is no way to predict what treatments are most likely to be effective in individual patients. This initiative will foster development of integrated models of back pain to improve understanding of the condition and generate new tools for better targeting of existing and new therapies.


On September 6, 2017, the NIAMS Advisory Council considered several initiative proposals. NIAMS is moving forward with the following initiatives for Fiscal Year 2019, pending the availability of funds.

Clinical Observational Studies (COS) in Musculoskeletal, Rheumatic, and Skin Diseases Re-Issue

Description:
This initiative will support clinical observational studies to obtain information that is necessary for designing clinical trials for musculoskeletal, rheumatic, or skin diseases or conditions. Data obtained through the studies may also have a direct impact on clinical care. Applications can include characterization of cohorts similar to potential future trial participants and collection of data to justify the use of a biomarker or a patient outcome measure in a future trial. Researchers must explain how the data they propose to collect could contribute to the design of a clinical trial or trials in the near term. This initiative will emphasize the collection of data that addresses significant obstacles to the design of a clinical trial or trials. Applicants will be required to justify the need for the observational study in preparing for a future trial or trials.

Expected Benefit to the Public Health:
This initiative will improve understanding of diseases and conditions within the NIAMS mission. Research data from observational cohort studies can enhance clinical trial design by providing essential information about disease symptoms, stages and timing of disease progression, comorbid conditions, availability of potential clinical trial participants, and outcomes that are important to patients. Clinical observational studies also can facilitate efforts to validate and eventually qualify objective biomarkers or subjective outcome measures for use in future trials or in the clinical care setting.

Core Centers for Clinical Research (CCCR) Re-Issue

Description:
The CCCRs provide avenues to advance the methodological sciences that support clinical research within and across the NIAMS' portfolio of diseases. The overall goals of the CCCR are to advance prevention, diagnosis and treatment of musculoskeletal, rheumatic, and skin diseases by developing and fostering the implementation of novel methods, metrics, and outcome measures that address critical existing and emerging clinical research needs.

Expected Benefit to the Public Health:
This initiative builds on emerging thinking and innovative ideas, such as the surge in 'omics' data, enabling these new approaches to ultimately improve health-related outcomes for patients with musculoskeletal, rheumatic, or skin diseases or conditions.

Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases Re-Issue

Description:
This initiative would address the need to support and facilitate clinical trials that can be completed within a limited timeframe and budget. A broad range of types of exploratory studies are suitable for this initiative. The trials must address research questions related to the mission and goals of the NIAMS and may evaluate interventions with drugs, biologics, devices, or surgical, dietary, behavioral or rehabilitation therapies.

Expected Benefit to the Public Health:
This initiative will improve understanding of diseases and conditions within the NIAMS mission by fostering clinical trials that will lead to clinically meaningful improvements in prevention, diagnosis, or treatment of these diseases.

Mechanistic Ancillary Studies to Ongoing Clinical Projects Re-Issue

Description:
This initiative would leverage the existing resources offered by already-funded clinical studies, and maximize the return on the public investment. Successful ancillary studies would enhance the scientific content and value of the parent studies, improve our understanding of the underlying mechanisms of diseases in the NIAMS portfolio, and thus identify novel targets for the diagnosis, treatment, and prevention of disease.

Expected Benefit to the Public Health:
Clinical studies, ranging from epidemiological observational studies to clinical trials, play a valuable role in carrying out the mission of the NIAMS. Large clinical projects offer unique opportunities to conduct additional investigations that go beyond the core activities of the original study and generate new information related to the original study.

Research Innovations for Scientific Knowledge (RISK) Initiative Re-Issue

Description:
The NIAMS RISK initiative is an effort to encourage and facilitate innovative research in NIAMS-supported communities. It is designed to capture and test novel and audacious ideas in their early stages of development, which may be less likely than more conventional proposals to be funded using traditional NIH funding mechanisms.

Expected Benefit to the Public Health:
The initiative provides a way for the Institute to encourage highly innovative research and to accelerate testing of high-risk and high-impact ideas. The research funded through RISK has the potential to produce breakthroughs or paradigm shifts that improve public health or launch new fields of scientific inquiry.

Resource-based Centers Re-Issue - Musculoskeletal Biology and Medicine

Description:
The overall goal of the NIAMS Resource-based Centers program is to promote a cooperative interaction among basic science and/or clinical investigators in a manner that will enrich the effectiveness of ongoing research and promote new research. For these Musculoskeletal Biology and Medicine Resource-based Centers, the emphasis will be on improving access to resources. This includes the potential for either resources or investigators to be distributed at different institutions, particularly for technical resources that do not need to be duplicated at every institution. Shared resource cores could be typical core facilities, or may provide access to unique expertise or services, such as epidemiology, outcomes, genetics, or informatics, which may be necessary to address a common problem.

Expected Benefit to the Public Health:
Musculoskeletal Biology and Medicine Resource-based Centers enable research that should advance understanding of human disease and promote the discovery of the causes, treatment and prevention of musculoskeletal diseases.

Resource-based Centers Re-Issue - Skin Biology and Diseases

Description:
The overall goal of the NIAMS Resource-based Centers program is to promote a cooperative interaction among basic science and/or clinical investigators in a manner that will enrich the effectiveness of ongoing research and promote new research. For these Skin Biology and Diseases Research Resource-based Centers, the emphasis will be on improving access to resources. This includes the potential for either resources or investigators to be distributed at different institutions, particularly for technical resources that do not need to be duplicated at every institution. Shared resource cores could be typical core facilities, or may provide access to unique expertise or services, such as epidemiology, outcomes, genetics, or informatics, which may be necessary to address a common problem.

Expected Benefit to the Public Health:
Skin Biology and Disease Research Resource-based Centers enable research that should advance understanding of human disease and promote the discovery of the causes, treatment and prevention of skin diseases.

Supplements to Advance Research (STAR) from Projects to Programs Re-Issue

Description:
The objective of the NIAMS STAR Program is to promote innovation and exploration of high-risk ideas by providing supplemental funding to early established investigators (EEIs). The STAR Program supports activities that effectively allow EEIs to expand and explore new opportunities within the broader scope of a currently funded, peer-reviewed research project to facilitate the transition from a single, structured research project to a research program.

Expected Benefit to Public Health:
This initiative will contribute to NIAMS efforts to support promising investigators as they develop robust research programs.

Translational Research in Hidradenitis Suppurativa

Description:
Encouraging pre-clinical research on hidradenitis suppurativa (HS) through this initiative has the potential to lead to a better understanding of the pathogenesis and genetics of the disease, as well as define several potential novel targets for repurposing of available drugs or development of new treatments. HS is a complex chronic inflammatory skin disease characterized by recurrent painful nodules and suppuration in different areas of the body such as the axilla and groin.

Expected Benefit to the Public Health:
There is no biological or pathological test to diagnose HS, which is defined only by its clinical features. HS is known to affect three-times more women than men, and is more prevalent among minorities (e.g., African Americans). Disease pathogenesis is poorly understood and available treatments are limited.