UW Clinical Trials Institute

The FDA's final guidance on decentralized clinical trials (DCTs) addresses some key issues from the draft guidance raised by clinical experts and #industry groups, including providing more information on requirements to keep a task log of #healthcare providers, physical inspection requirements, and clarifying challenges around #data variability in DCTs. The final guidance provides recommendations for using decentralized components in #clinicaltrials. This includes elements like such as use of decentralized health technologies and #software, roles and responsibilities for sponsors and investigators, using local healthcare providers as well as remote clinical trial visits, and trial design, conduct, and oversight. The final guidance also outlines informed consent and institutional review board oversight, what investigational products can use a DCT, how to package and ship investigational products, and patient safety processes and procedures. Article: 'FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability' https://lnkd.in/gnz8GW4s via Regulatory Affairs Professionals Society (RAPS) #FDA #clinicalresearch #technology

Last week, the tribal council of the Sokaogon Chippewa Community (SCC) in northern #Wisconsin traveled to the University of Wisconsin-Madison to meet with UW Chancellor Jennifer Mnookin and #health sciences and #biomedical researchers and staff. The group discussed collaborating on #clinicaltrials and health #data collection, along with strategies to improve health within the SCC. Among the presenters were Elizabeth (Betsy) Nugent, chief clinical research officer, UW School of Medicine and Public Health (SMPH) and UW Health and UW CTI director and Dr. Rafael Veintimilla, senior director of clinical trials integration and medical science liaison for the UW CTI. "Nugent explained how clinical trials unfold and their importance to advancing medicine. Veintimilla stressed the need to make early-stage (Phase 1) trials patient-centric by addressing barriers, questions and concerns." The meeting underscored the critical need for historically marginalized populations, including #indigenous communities, to participate in clinical trials to help ensure that all communities can benefit from the development of more effective medications and #medical devices. Article: 'Building trust with a Native community' https://lnkd.in/gCNf-XXM via UW SMPH #university #clinicalresearch #healthequity #community #OnWisconsin

CTI Team Spotlight: Meet Meg Marie Hackbarth! Meg, who works with us as a Clinical Research Coordinator, offers advice for those who want to pursue a career in #clinicalresearch and discusses her role at the University of Wisconsin-Madison and UW Health. "I appreciate the opportunity to contribute to a collaborative environment where innovative ideas thrive. My role allows me to engage with diverse teams, tackle challenging projects, and continuously develop my skills. This dynamic setting not only fosters personal growth but also drives the success of our collective goals." Learn more about Meg's role, her career path, and the resources that have helped her along the way: https://lnkd.in/gsUwJGwd #university #Wisconsin #clinicaltrials #healthcare #careers #innovation #workforce

Stem-cell transplants have freed seven people of #HIV, but researchers say most long-term interventions remain a distant prospect. This article explores the current state of HIV research, including #clinicaltrials aimed at exploring #vaccine development, HIV treatment, and transmission #prevention. Article: 'HIV: How close are we to a vaccine–or a cure?' https://lnkd.in/ekgyPJvZ via Nature Magazine #clinicalresearch #health #stemcells #innovation

Check out our Fall 2024 'Clinical Research Corner' #newsletter to access our 2024 Annual Report and other news, events, and #jobopportunities related to the #clinicalresearch #community at the University of Wisconsin-Madison and UW Health! https://lnkd.in/gPNQbbEY #university #Wisconsin #clinicaltrials #healthcare #innovation

Dorota Grejner-Brzezinska recently joined the University of Wisconsin-Madison as its new Vice Chancellor for Research and as a faculty member in the UW-Madison Department of Electrical and Computer Engineering. She oversees the Office of the Vice Chancellor for Research, boasting more than $1.52 billion in annual research expenditures, a figure that puts UW–Madison in the top 10 in the nation among universities for volume of research. The office includes administration of 20 cross-campus research offices and interdisciplinary centers. So, what attracted her to UW–Madison? "Many things, but mostly the nationally and internationally recognized research strengths, the culture of collaboration across the disciplinary fields and the intellectual curiosity that seems to be a signature trait of the faculty, staff and students who I have met so far, the depth and the breadth of their expertise, and the size and diversity of this great institution. And, of course, the challenges that I feel we can translate to opportunities by working together to form cross-disciplinary and multi-sectoral teams that will accelerate paths to solutions to the most vexing societal problems and benefit not only #Wisconsin but also the region, the nation, and the world." Article: 'New vice chancellor for research feels at home on the shores of Lake Mendota' https://lnkd.in/gx7xsyBV via UW–Madison #university #leadership #education #clinicalresearch

A new #podcast, 'Cancer Clear and Simple,' hosted by the UW Carbone Cancer Center, explores how inequities and barriers in #cancer research, screening and #healthcare create life-threatening disparities for many people in #Wisconsin and beyond. Article: 'New podcast sheds light on cancer inequities' https://lnkd.in/gY8DbWcU via UW Health #university #clinicalresearch #healthequity

Job Opportunity: Join our team as Director, Clinical Trials Implementation & Coordination! The Director of Clinical Trials Implementation and Coordination, within the UW CTI, will manage #clinicaltrials study activation and coordination across the UW Health and University of Wisconsin-Madison enterprise. The position will provide oversight and management to the Portfolio Management Team, providing start-up #management, and the #clinicalresearch coordinator teams providing study implementation and #coordination services. Learn more and apply by 9/20: https://lnkd.in/g3Xq8p3A #university #Wisconsin #health #jobopportunities #careers

The University of Wisconsin-Madison is ranked first among national public universities and 12th overall in The Washington Monthly’s 2024 College Guide and Rankings. The rankings are based on a school’s contribution to the public good in three categories: social mobility, #research, and providing opportunities for #publicservice. Article: 'Washington Monthly ranks UW as No. 1 public university' https://lnkd.in/gyiZcXQi via UW–Madison #OnWisconsin #education #community #leadership

The University of Wisconsin-Madison is seeking nominations for its annual 'Outstanding Women of Color Awards.' The Awards acknowledge and honor #women of color among UW–Madison’s faculty, staff, students (undergraduate or post-baccalaureate) and in the greater #Madison #community. Learn more and submit a nomination by 9/27: https://lnkd.in/gPbaW9Uv via UW–Madison Division of Diversity, Equity & Educational Achievement #university #Wisconsin #education #DEI #leadership