The mission of the UNC Pharmacoepidemiology Program is to advance public health through educating diverse audiences, developing innovative methods, and disseminating robust evidence on the uses and effects of medical interventions.
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Chapel Hill, North Carolina, US
ICYMI: The FDA recently announced the launch of a new Center for Real-World Evidence Innovation (CCRI)
Today, CDER announced the new Center for Real-World Evidence Innovation (CCRI) which aims to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making ➡️ https://lnkd.in/eQXpkajD
Great presentation by Sebastian Schneeweiss during the 17th Annual Harry Guess Memorial Lecture organized by the UNC student chapter of the International Society for Pharmacoepidemiology Dr. Schneeweiss presented on extensive work on target trial emulation and challenges encountered in RWE
UNC Pharmacoepi reposted this
We are pleased to share that the 17th Annual Harry Guess Memorial Lecture hosted by the UNC-CH Student Chapter of the International Society for Pharmacoepidemiology will feature Sebastian Schneeweiss. 📅 October 23, 2024 | 2:00 – 3:00 PM EST Tate-Turner-Kuralt Auditorium, Room 136 🔗 Registration link: https://lnkd.in/e38ypF3A
⚠️ Index date selection continues to be a critical source of bias in pharmacoepidemiologic studies. 🔎 Aiming to generate RWE and regulatory guidance on this issue, the FDA has funded a project led by Michele Jonsson Funk and Jennifer Lund through the Triangle CERSI
And last but not least, Michele Jonsson Funk, Jennifer Lund (UNC Gillings School of Global Public Health, UNC Pharmacoepi, UNC Lineberger Comprehensive Cancer Center) and team begin a new Triangle CERSI project to tackle a well-known challenge with using external #comparatorgroups for #clinicaltrials, particularly in #oncology. An index date is the starting point for measuring outcomes. The timing of when to start tracking outcomes in the comparator group affects the estimated risks and can introduce biases. By using simulations and real-world examples, the research team aims to evaluate different index date selection strategies and their impact on bias and outcome estimation. The findings will inform FDA discussions, support regulatory decisions, and enhance the understanding of external comparator arm designs, particularly in complex settings like #rarediseases and oncology. This project addresses charge 1 of the FDA’s regulatory science framework: Modernize development and evaluation of FDA-regulated products with a focus on methods to assess #realworlddata to serve as #realworldevidence. The Triangle CERSI is a Center of Excellence funded by the FDA to University of North Carolina at Chapel Hill and Duke University with partners, North Carolina Central University and North Carolina State University. To date, the Triangle CERSI has generated $11.1 million toward accelerating access to emerging scientific approaches essential for the FDA to remain at the forefront of regulatory decision making.
We are pleased to share that the 17th Annual Harry Guess Memorial Lecture hosted by the UNC-CH Student Chapter of the International Society for Pharmacoepidemiology will feature Sebastian Schneeweiss. 📅 October 23, 2024 | 2:00 – 3:00 PM EST Tate-Turner-Kuralt Auditorium, Room 136 🔗 Registration link: https://lnkd.in/e38ypF3A
UNC Pharmacoepi faculty Mollie Wood published a commentary in the Paediatric & Perinatal Epidemiology journal's recent special issue on pharmacoepidemiology. The commentary, titled “Studying early pregnancy exposures and outcomes in routinely collected healthcare data: conceiving of target trials” discusses methodologic issues related to studying pregnancy in real world data, including immortal person time, left truncation, and competing events. 🔗 https://lnkd.in/euGE_QuM The commentary was on a recent paper by Grandi et al (https://lnkd.in/enwF9xkx), which used UK CPRD data to study the effects of levothyroxine treatment for subclinical hypothyroidism on pregnancy loss. #RWE #RWD #PregnancyResearch
Please join us in congratulating Jennifer Lund, core faculty at UNC Pharmacoepi, for her promotion to Professor at the UNC Gillings School of Global Public Health! 🎉 Dr. Lund also serves as Director of Data Strategy and Education with the UNC Lineberger’s Cancer Information and Population Health Resource (CIPHR). She conducts pharmacoepidemiologic and health services research, with applications in cancer, aging, and the environment. https://lnkd.in/de5s9r_U
UNC Pharmacoepi reposted this
PhD Candidate in Epidemiology at UNC-Chapel Hill | Pharmacoepi, Pregnancy, and Epidemiology Methods
Ever find it challenging to explain the nuances of Hazard Ratios when estimating treatment effects? Or maybe you're looking to deepen your own understanding? In our newly published article in Pharmacoepidemiology and Drug Safety, we explore this through a real-world example where the Hazard Ratio indicates a treatment benefit, but the Risk Ratio does not. We quantify the treatment effect using various measures in an effort to shed light on these important distinctions! Check it out here: Link: https://lnkd.in/dNRRTgKJ. A big thank you to my co-authors - Claire I-Hsuan Su, Megan Delgado, Virginia Pate, Charlie Poole, Jess Edwards, Til Stürmer, Jennifer Lund, and Michele Jonsson Funk - for their incredible contributions to and insights on this project! #Epidemiology #MedicalResearch #StatisticalAnalysis #PublicHealth
Congratulations to Thibaut Davy-Mendez, UNC Epid Faculty, for his spotlight poster award in the Adherence category at #ISPEAnnual2024! His work is titled: “Gender differences in statin persistence across racial and ethnic groups among persons with HIV in the United States”
It was a great #ISPEAnnual2024. Thank you for following our research and engaging with our trainees, alumni, and faculty. Hope to see you all next year in Washington DC!