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Goal #7:  Training and career support programs for translational scientists

OverviewThis course provides an overview of basic principles of clinical research design, including biostatistics; study design and interpretation of diagnostic and predictive test studies; and required and desired elements of clinical trial protocols. Participants will be introduced to the regulatory aspects of clinical research conduct and oversight, Good Clinical Practice principles, and ethical dimensions of clinical research.&nbsp;Course Details The On-Demand Essentials of Clinical Research will be available starting May 2025. These are the recorded seminars from January to March 2025. This information is for learning purposes only. An evaluation is requested at the end of the course. Presentations and resources are available. A certificate will not be issued.&nbsp;Registration is open for the 2025 Essentials of Clinical Research. The course will be held in person with a zoom option for our out-of-state participants. Note, the course takes place from 7:00 – 9:00 p.m. ET. While the course is recorded for course participant viewing, participants should plan to attend the LIVE sessions. Enrolled participants may be dropped from the course if there are more than 3 absences. Please complete the knowledge tests and evaluations within the allotted time frame to receive a course completion certificate, and Continuing Medical Education (CME) credit, if offered. CME credit is applicable towards clinician and nurse license renewals…&nbsp;Register <a href="https://stanfordmedicine.qualtrics.com/jfe/form/SV_8CAFXfiw2A9BF5Q" target="_blank" rel="noopener noreferrer">here</a>.Read the full article <a href="https://med.stanford.edu/spectrum/education-and-training/essentials-of-clinical-research-course.html#overviewhttps://med.stanford.edu/spectrum/education-and-training/essentials-of-clinical-research-course.html#overview" target="_blank" rel="noopener noreferrer">here</a>.

Stanford Center for Clinical & Translational Education and Research (Spectrum)

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Stanford

Registration Open for the 2025 Essentials of Clinical Research Course

Goal #1: Advance clinical and translational science

Morehouse School of Medicine (MSM) is proud to announce that <a href="https://researchwebportal.msm.edu/staff/priscilla-e-pemu/" target="_blank" rel="noopener noreferrer">Priscilla Eyikojoka Pemu, M.D., M.S., FACP, FAHA</a>, has been elected to the illustrious National Academy of Medicine (NAM). Dr. Pemu is a Professor of Clinical Medicine. She serves as Associate Dean for Clinical Research and Director of the MSM Clinical Research Center.&nbsp;NAM indicated that Dr. Pemu was recognized for “pioneering work on clinical trial diversity, centering on the importance of regaining trust, fostering transparent collaboration and ensuring the equitable participation of diverse populations in medical research, from Grady Health System, a large public hospital, to primary care practices, historically Black churches and institutions.”&nbsp;“Your election reflects the high esteem in which your peers and colleagues regard you,” the Academy told Dr. Pemu in a letter announcing her election. “As a NAM member, you are now part of a group of truly distinguished individuals who have made important contributions to health, medicine and science…"&nbsp;Read the full article <a href="https://www.msm.edu/RSSFeedArticles/2024/October/Priscilla-Pemu.php" target="_blank" rel="noopener noreferrer">here</a>.

Georgia Clinical and Translational Science Alliance

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Morehouse School of Medicine Inc. (MSM)at Emory University

Morehouse School of Medicine Faculty Member Dr. Priscilla Pemu is Elected to National Academy of Medicine

The University of <a href="https://www.uab.edu/home/" target="_blank" rel="noopener noreferrer">Alabama at Birmingham (UAB)</a> startup TIXiMED, Inc., has obtained clearance from the United States Food and Drug Administration to proceed to clinical trials under an Investigational New Drug for TIX100, its novel oral Type 1 diabetes drug. This represents a major milestone in the development of this new approach to T1D treatment and gives TIXiMED the green light to start human studies with TIX100.&nbsp;The development of TIX100 is based on decades of research by <a href="https://scholars.uab.edu/393-anath-shalev" target="_blank" rel="noopener noreferrer">Anath Shalev, M.D.</a>, the Nancy R. and Eugene C. Gwaltney Family Endowed Chair in Juvenile Diabetes Research in the UAB <a href="https://www.uab.edu/medicine/endocrinology/" target="_blank" rel="noopener noreferrer">Division of Endocrinology, Diabetes and Metabolism</a> in the <a href="https://www.uab.edu/medicine/dom/" target="_blank" rel="noopener noreferrer">Department of Medicine</a> and the director of the UAB <a href="https://www.uab.edu/medicine/diabetes/research" target="_blank" rel="noopener noreferrer">Comprehensive Diabetes Center</a>…&nbsp;Read the full article <a href="https://www.uab.edu/news/research/item/14275-type-1-diabetes-uab-startup-gains-fda-clearance-to-test-novel-oral-drug" target="_blank" rel="noopener noreferrer">here</a>.

University of Alabama at Birmingham Center for Clinical and Translational Science

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University of Alabama at Birmingham

Type 1 Diabetes: University of Alabama at Birmingham Startup Gains FDA Clearance To Test Novel Oral Drug

Researchers at Penn State are using machine learning and existing electrocardiogram data to help doctors make more accurate predictions. With support from <a href="https://ctsi.psu.edu/" target="_blank" rel="noopener noreferrer">Penn State Clinical and Translational Science Institute (CTSI)’s</a> seed grant program, a team of artificial intelligence engineers, in collaboration with a team of physicians from <a href="https://research.med.psu.edu/departments/heart-vascular-institute/" target="_blank" rel="noopener noreferrer">Penn State Heart and Vascular Institute</a>, is working to develop novel algorithms for point-of-care, in-house use and for technology licensing.&nbsp;“With stronger algorithms and a larger database, we can predict cardiovascular outcomes at significantly less cost," said <a href="https://pure.psu.edu/en/persons/ankit-maheshwari" target="_blank" rel="noopener noreferrer">Ankit Maheshwari, M.D.,</a> assistant professor of medicine at Penn State and lead researcher on the project. "And there are several other examples out there where it can make health care more efficient and more effective..."&nbsp;Read the full article <a href="https://www.psu.edu/news/clinical-and-translational-science-institute/story/cardiology-collaboration-advances-machine" target="_blank" rel="noopener noreferrer">here</a>.

Penn State Clinical and Translational Science Institute

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Pennsylvania State University

Cardiology Collaboration Advances Machine Learning Predictions

Stress, that nebulous mixture of anxiety and tension, comes in many different forms.&nbsp;Often, stress can be temporary—and even beneficial for productivity—such as the nerves you might feel before a big meeting or before running a marathon, helping you tackle the moment at hand. Stress can also be chronic, when tension over difficult situations builds up in a seemingly endless stream of worry and fear. And according to a <a href="https://www.apa.org/news/press/releases/stress/2023/november-2023-topline-data.pdf" target="_blank" rel="noopener noreferrer">recent report</a> from the American Psychological Association, American adults report feeling stressed over everything from personal concerns like money and relationships to societal concerns like mass shootings, crime, and climate change.&nbsp;In addition, stress is not a simple feeling, with symptoms ranging from headaches and chest tightness to an upset stomach. "It is a very complex body-brain response," says <a href="https://www.med.unc.edu/psych/people/aysenil-belger-phd/" target="_blank" rel="noopener noreferrer">Aysenil Belger, Ph.D.</a>, a biological psychologist at the University of North Carolina School of Medicine…&nbsp;Read the full article <a href="https://tracs.unc.edu/index.php/news-articles/2276-a-personal-approach-to-the-biology-of-stress" target="_blank" rel="noopener noreferrer">here</a>.

North Carolina Translational and Clinical Sciences Institute

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University of North Carolina at Chapel Hill

A Personal Approach to the Biology of Stress

Goal #3: Address health disparities 

Pregnancy is often a risky time for women, but in the U.S., a woman’s pregnancy can present even more complications depending on where she lives.&nbsp;Recently, the March of Dimes classified more than 35% of U.S. counties as "maternity care deserts," with little or no access to pre- or postnatal care. With <a href="https://www.commonwealthfund.org/publications/issue-briefs/2024/jun/insights-us-maternal-mortality-crisis-international-comparison" target="_blank" rel="noopener noreferrer">nearly two out of three deaths</a> occurring during the postpartum period—particularly through heart conditions, infection, hemorrhage, high blood pressure or stroke—the lack of access for women in the year after giving birth can be critical.&nbsp;To address the health issues that often come with maternal health care deserts, the National Institute of Health’s (NIH) Rapid Acceleration of Diagnostics Technology (RADx) program launched the <a href="https://www.nichd.nih.gov/research/supported/challenges/radx-tech-maternal-health" target="_blank" rel="noopener noreferrer">Maternal Health Challenge</a>—a competition to develop new medical devices women can use at home or in clinics to help detect, diagnose and monitor diseases in the first year after birth…&nbsp;Read the full article <a href="https://news.emory.edu/stories/2024/11/er_radx_maternal_07-11-2024/story.html" target="_blank" rel="noopener noreferrer">here</a>.

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Emory University

Emory Researchers Evaluate New Devices to Help Mothers in Areas Lacking Maternal Care Resources

View the latest news from the CTSA Program, hubs, and the CCOS Center. Please submit any content you would like to see featured on the CCOS website or in the Ansible newsletter to <a href="mailto:communications@ccos.ctsa.io">communications@ccos.ctsa.io</a>.

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