JOHN HOPE FRANKLIN CENTER

Registration is open for the Great Plains IDeA-CTR’s 2024 Annual Scientific Meeting on Oct. 21 at the University of Nebraska at Omaha’s Scott Conference Center. The free event, themed “Leveraging AI and Innovative Study Designs to Transform Healthcare and Improve Patient Outcomes,” offers up to five continuing education credits and features speakers on AI in healthcare, NIH funding, and health data management. The CTR Superstar Competition will award $35,000 to a promising scholar. Register soon due to limited seating.

A study reveals nearly half of AI medical devices authorized by the FDA lack clinical validation data, raising concerns about their effectiveness and safety. Researchers call for clearer standards in clinical validation, emphasizing the need for the FDA to differentiate among retrospective, prospective, and randomized controlled trials.

The fifth edition of the blog series on decentralized clinical trials (DCTs) highlights the benefits of DCTs, such as increased accessibility and diversity in clinical trials, but also emphasizes the risks of research misconduct, particularly data integrity concerns and challenges with principal investigator oversight. The Office of Research Integrity's revised regulations affect DCTs, requiring institutions to implement safeguards like smart hiring, incentivizing data accuracy, and developing monitoring systems to mitigate these risks.

Priovant Therapeutics has initiated the CLARITY Phase 3 study evaluating brepocitinib for non-anterior non-infectious uveitis (NIU), following Fast Track Designation by the FDA. Brepocitinib, a dual selective inhibitor of TYK2 and JAK1, demonstrated significant efficacy in the NEPTUNE Phase 2 study, with patient-level wide field fluorescein angiography results showing a dose-dependent decrease in retinal vascular leakage. The CLARITY study will compare brepocitinib 45 mg to placebo in 300 patients globally, with results expected by the end of 2024.

Yale’s Department of Biomedical Informatics and Data Science (BIDS) welcomes Haoyu Cheng, Anran Li, Andrew Loza, Julia Wolleb, Weipeng Zhou, João Cardoso, Catherine Barabas, Gui Yang, Mukund Aravapalli, Jennifer Arango, Ahmed Abdelhady, Winnie Ng, Vincent Zhang, and Atharva Sapre, each contributing unique expertise in genomics, AI, software engineering, and healthcare informatics.

Johns Hopkins University ranked No. 6 in the U.S. News & World Report's national universities list, tied with Caltech, Duke, and Northwestern. Hopkins has been in the top 10 since 2019 and top 20 since the 1980s rankings began. The university also ranked No. 1 in biomedical engineering, No. 5 in biocomputer/bioinformatics/biotechnology, and No. 18 in artificial intelligence among undergraduate programs.

Mohab Ibrahim, an anesthesiologist, discovered green light's pain-relieving effects after experiencing relief in a park. His team found that green and blue light reduced rats' sensitivity to pain, focusing on green due to blue's side effects. Human trials showed green light significantly reduced migraine and fibromyalgia pain with no side effects. The mechanism involves the visual system, specifically cones and rods, activating enkephalinergic neurons in the thalamus to release endogenous opioids for pain relief.

First patients dosed in CLARITY Phase 3 study evaluating brepocitinib for non-anterior non-infectious uveitis (NIU), with Fast Track Designation granted by FDA. Study follows successful Phase 2 NEPTUNE trial, presenting dose-dependent improvement in retinal vascular leakage at EURETINA conference. CLARITY aims to compare brepocitinib 45 mg to placebo in global multi-center study.

FDA to mandate diversity action plans for clinical trial sponsors, aiming to improve enrollment of underrepresented populations, with quotas and strategies to reflect the patient population.

The article profiles various professionals in health and statistics, including John R. Lumpkin, M.D., M.P.H., Mollyann Brodie, Ph.D., Kennon R. Copeland, Ph.D., Tara Das, Ph.D., M.P.H., M.L.I.S., Scott H. Holan, Ph.D., V. Joseph Hotz, Ph.D., Bradley Malin, Ph.D., Sally C. Morton, Ph.D., Lucila Ohno-Machado, M.D., M.B.A., Ph.D., Andy Peytchev, Ph.D., C. Matthew Snipp, Ph.D., Kelly Hoover Thompson, J.D., and David R. Williams, Ph.D., detailing their roles, achievements, and contributions to their respective fields.