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Our goal is to leverage our existing, scalable, multi-center hardware and software platform for employing established and novel artificial intelligence (AI) strategies for dynamic predictive monitoring (DPM), aimed at reducing health disparities and inequities.
We recognize that “intelligent” systems are only as effective as the quantity and quality of data avail-able for their ingestion. Because adequate sampling of large amounts of data ultimately influence the learning component, AI systems
can become biased based on the paucity of data available from underrepresented minority (URM) groups. Thus, one of our key goals is to collect massive amounts of data from URMs with high granularity on race/ethnicity. For example, African American
or black is not adequate for classifying our patients. We plan to impose a combined geographical-genealogical approach to supplement current data models. While our platform can extract massive amounts of data from multiple large academic centers,
experience has taught us that quantity of data does not compensate for noise, artifact, or data of poor quality. Thus, we have implemented powerful new approaches for extracting EHR and bedside monitor waveforms at the highest spatiotemporal resolutions
while removing noise, and this is another key goal. Indeed, our AI systems learn to identify the signal noise in a personalized manner and scale data signal collection and analysis accordingly.
To translate recent discoveries into better treatments for people in need, efficient clinical trials are needed. These trials require cooperation and coordination among investigators, study subjects and funding partners. Clinical trial networks
can increase the efficiency of research by providing infrastructure, centralized resources and access to study participants; however, multi-center clinical trials are frequently limited by delayed start-up and slow recruitment, particularly in patient
populations with rare heart, lung, blood and vascular disease or more common disorders that occur rarely in special populations.
We embrace a comprehensive approach to training the next generation of investigators to conduct clinical research in rare heart, lung, blood and vascular disease. Our program will provide the necessary skills and comprehensive understanding of clinical
trial operations for the trainee to appreciate a comprehensive spectrum of T1 through T4 research - bench-to-bedside-to community. In addition, we will employ a curriculum embedded within a learning environment that will allow graduates of our program
to contribute to the conduct of site-based clinical research, coordinating center activities, network development and training of clinical research collaborators. We will, through education, training and research excellence exposure 1.establish a
mechanism for graduates to define and share best practices to engage, support, and invest sites in clinical research; 2.use rare heart, lung, blood and vascular disorders as a model for developing common data elements and standard terminology that
can be shared among researchers, clinical sites and networks; and 3.assist sites and investigators in their efforts to establish a clinical trials infrastructure that facilitates sponsor contracts, protection of human subjects, regulatory compliance,
site start-up, study subject identification, recruitment and retention, data collection and reporting.
A centralized resource focused on providing expertise in clinical trial design, recruitment and retention strategies, biostatistics, education and training, contracts, standardized master study agreements and regulatory documents, financing, federated
IRB models, proposed changes to regulations governing human subjects research, electronic data entry, IND submissions and reporting to the Food and Drug Administration (FDA), development of operational and publication guidelines, clinical trial governance
and Steering Committees, metrics for tracking and reporting trial performance, Data and Safety Monitoring Committees and community relations is expected to assist in the timely planning, initiation and successful completion of clinical trials.
Fundamental Components: Recruitment and retention are vital components of our program; however, in addition we believe strongly that trainees who are likely to remain in academia must be sought actively in the review process. Accordingly, we will perform
regional and national searches for candidates each year. Identification of the best candidates for research training is an important first step, but equally important to retention in academics is the level of support given to recent program graduates
who are trying to create a sufficient body of work to become competitive for important extramural funding. To help support our graduates who elect to stay at UCMC or CCHMC, the Division of Cardiovascular Health and Disease and the HCRI will jointly
commit to provide 50% protected research time to each individual for up to two years as they prepare career development grant proposals.
Diversity in science and medicine is required for discovery science, clinical research and both implementation and dissemination of findings to the community where the greatest benefit to society can be realized. Therefore, we propose enrolling a minimum
of 50% women and minority trainees. Employing both national and regional searches and active on-site recruitment, we are confident that we can achieve this ambitious performance benchmark. The University of Cincinnati College of Medicine, UCMC and
CCHMC have the distinction of enrolling a high number of minority students and women in its training programs and similar representation for its staff and faculty. Our presence within the community as summarized in section XXXX also contributes to
an environment of inclusivity and diversity. Our mentors include early, mid and later stage academic faculty members.
We employ a career development team mentoring strategy that includes three mentors: the primary research mentor who will typically have a focus in one of the areas of clinical cardiovascular, blood or pulmonary medicine, a methodology mentor and a program/career
mentor. Each trainee will be required to create an individual development plan (IDP) at the beginning of their training that will serve as a road map for their T32 training. Our principal investigators and primary coinvestigators will work with the
mentoring teams to ensure that at least one major part of the trainees mentored research involves a project where the scholar initiates the research concept, creates a draft proposal, applies for intramural funding to pay for analyses and other expenses
involved, and completes the work within the time frame of their training experience. Emphasis will be placed on projects that, if successful, can potentially lead to additional research that should be competitive for external funding-specifically
a K or other early career development grant.
Each of our scholars is required, as part of their training, to pursue funding. In support of this requirement each scholar will participate in the CCHMC K club that is designed to develop an understanding of grant writing with the goal of preparing competitive
NIH career development award applications. Each trainee will be required to prepare and submit either a K grant or similar career development grant. Graduates of our program who remain at UCMC or CCHMC as junior faulty will be strongly encouraged
to apply for independent federal funding and to participate in the UC College of Medicine career development program, that includes structured workshops, open discussion with established faculty members with a strong track record of NIH funding, as
well as reviews and feedback on drafts of grant applications. Our goal is to set high standards and establish a foundation of academic success while providing the necessary resources for our trainees to succeed in their academic endeavors.
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