In this week's round-up from The Evidence Base®: A new article in Health Affairs Forefront discusses the need for a more #holistic view of #valueassessment to include health services and procedures to better reflect the diverse needs and outcomes of health care in the US. With just over a month to go, we preview the International Society for Pharmacoepidemiology (ISPE) 2024 annual meeting taking place in Berlin, Germany. On July 25, 2024, the Duke-Margolis Institute for Health Policy will hold their annual public event discussing their latest activities within #RWE and #RWD policy developments. View our #infographic charting the history of the FDA’s #realworldevidence activities since 2016. Suzanne M. of Medlior Health Outcomes Research Ltd. talks about identifying #realworlddata sources and assessing for 'fit-for-purpose' data. Stuart McCully, Real-World Research Ltd, delves into #RWEterminology, and discusses how to foster a shared language. Amr M. (Janssen Inc.), Jasdeep Hayre (NICE - National Institute for Health and Care Excellence), Patrice Verpillat (European Medicines Agency), Carla Vossen and Pierre Net (Syneos Health), discuss the increasing use of studies involving #externalcontrolarms to support decision-making by regulatory and #HTA agencies for #rarediseases. Don't forget to view our #webinar: - The Goldilocks problem in oncology RWD: choosing the data that’s ‘just right’. Watch it on demand. Read our bi-monthly column highlighting the most popular articles from the the Journal of Comparative Effectiveness Research in May and June 2024. Plus, new articles from the Journal of Comparative Effectiveness Research, and #RWE and #RWD news from Verantos, Health Data Research UK (HDR UK), and the Center for Innovation & Value Research.
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In today's fastmoving healthcare landscape, the strategic use of real-world data (RWD) is a paramount trend shaping market access, evidence generation, and HTA submissions. The increasing reliance on RWD is a testament to its power in providing valuable insights into real-world patient experiences and meeting demands for robust, diverse evidence. Leveraging RWD allows us to bridge the gap between controlled research settings and the complexities of real-world patient outcomes. Drs Gemma Taylor and Joe Hollinghurst lead HEOR's data science team. Their internationally renowned experience in epidemiology, statistical methods, and data linkage ensures a deep understanding of RWD's nuances. Gemma and Joe offer their expertise in leveraging RWD across the pharmaceutical pipeline to help solve market access challenges. Don't miss the chance to tap into their invaluable insights - get in touch for a no-obligation discussion. #Healthcare #RWD #HEOR #MarketAccess #EvidenceGeneration #HTASubmissions https://heor.co.uk
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Today, on International Clinical Trials Day, we recognize the criticality and value of clinical trials in driving medical advancement to benefit society while protecting patient safety. By increasing participation of underrepresented populations in clinical trials – as we have done in Alzheimer’s disease, Parkinson’s disease and lupus – we believe we can better serve those living with the diseases we treat. In 2023, in collaboration with trusted partners, we held more than 35 community and faith-based events in the U.S. in an effort to advance equitable access to quality care and medicines. We will continue to work to build awareness and trust to ensure our clinical trials reflect the epidemiology of the disease. Learn how Biogen is connecting diverse communities to clinical research: https://ow.ly/fATP50RNW9T #ClinicalTrials | #InternationalClinicalTrialsDay | #HealthEquity
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Drug Discovery Scientist at NCATS/NIH || Medicinal/Synthetic Chemist || Ex President of SONSIK & CAPS || Ex National Secretary of PVP Nepal || Science Talk || Volunteering
#Announcement: Introducing RDAS - Rare Disease Alert System by NCATS/NIH. Link: https://lnkd.in/eXjG-VK7 At RDAS, we understand the critical need for timely, accurate, and accessible information for rare disease patients, caregivers, and healthcare providers. The NCATS team is thrilled to introduce the NCATS Rare Disease Alert System (RDAS) – a groundbreaking initiative designed to revolutionize how we navigate the complexities of rare diseases. #Why RDAS Matters: Rare disease patients often face daunting challenges, from diagnosis delays to misdiagnosis. To address this, RDAS focuses on collecting and sharing standardized, up-to-date data on rare diseases. Our goal is simple yet profound: to shorten the diagnostic odyssey and empower individuals with the knowledge they need to make informed decisions about their health. #What RDAS Offers: - Comprehensive Resource: RDAS serves as a public repository, bringing together data from various sources including publications, clinical trials, and NIH grant funding. - User-Friendly Interface: Our intuitive frontend UI allows users to effortlessly search, browse, and subscribe to RDAS. - Cutting-Edge Technology: Built upon a robust backend data repository, RDAS utilizes advanced technologies such as Neo4j database and deep learning models to create Knowledge Graphs (KGs) for seamless data integration. #Key_Features of RDAS: 1. Scientific Annotation Knowledge Graph (RDAS_SAKG): Annotated data from PubMed articles and epidemiology information to keep you informed. 2. Clinical Trial Knowledge Graph (RDAS_CTKG): Semantically represents data extracted from clinicaltrial.gov for comprehensive understanding. 3. NIH Grant Funding Knowledge Graph (RDAS_GFKG): #Get_Involved: Whether you're a patient, caregiver, researcher, or healthcare professional, RDAS welcomes your involvement. Together, let's make rare diseases less daunting and more manageable. Discover the power of RDAS today! #RareDisease #HealthcareInnovation #DataScience #RDAS #NCATS #HealthTech #PatientEmpowerment #NIH #scientist Rare Disease Research, LLC Rare Disease Day RARE DISEASES INTERNATIONAL Lifematters #Rare_Disease_Alert_System
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WORLD DIABETES DAY - ACCESS TO CARE 🌍🎧 How far do you live from a healthcare clinic? Around the corner or across the country? This year, #WorldDiabetesDay is highlighting the importance of access to diabetes care. In the Western world, we have come to expect easy access to healthcare facilities, but that's not always the case. For some remote locations such as Greenland, accessing health care can take days. And, access to health care is essential for people living with diabetes or other chronic diseases because they need regular treatment and screenings for complications. 🎧 DDEA PODCAST: DIABETES CARE IN REMOTE REGIONS Listen when we discuss access to care in our #podcast episode 'Diabetes Care in Remote Regions: The Greenlandic Perspective' with three experts in public health and epidemiology: https://lnkd.in/eTSs6MPm 🎙️ Stine Byberg, Team Leader and postdoctoral researcher affiliated with the Steno Diabetes Center in Greenland 🎙️@Trine Jul Larsen, researcher at the Center for Health Research at the University of Greenland 🎙️ Marit Eika Jørgensen is a researcher at the @Steno Diabetes Center in Greenland and Professor in Clinical Epidemiology at the University of Southern Denmark 🎙️ Host: Gretchen Repasky, Communication Director, Nordic EMBL Partnership for Molecular Medicine and University of Helsinki DDEA PROUDLY SUPPORTING RESEARCH-BACKED APPROACHES Considering these challenges with health care access, we need to do better with research-backed approaches to ensure public health. Here at DDEA, we are proudly supporting early-career researchers within the field of diabetes to contribute to the prevention and treatment of diabetes and making diabetes care available to everyone who needs it. 🔵 Read more about World Diabetes Day: https://lnkd.in/dbwn8F9 Diabetesforeningen Type1 - Tænketank for Diabetes #WorldDiabetesDay #WDD #diabetes #access #care #DDEA #research
S2, Episode 6 ─ Diabetes Care in Remote Regions: The Greenlandic Perspective
https://ddeacademy.dk
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🚀 Exciting Development from the Duke Margolis Institute RWE Portfolio! 🚀 The latest white paper explores the transformative potential of patient-generated health data (PGHD) in health care. PGHD, which includes health-related data created by patients or their caregivers, can significantly enhance pharmacoepidemiology by addressing key challenges like misclassification, representativeness, and missing information. 🔍 Key Highlights: 1.) Relevance, Reliability, and Quality: The paper outlines crucial indicators to evaluate if PGHD is fit-for-purpose, offering practical guidelines for the initial and ongoing use of PGHD in medical product development and surveillance. 2.) Regulatory Interest: PGHD provides valuable insights that can bridge important gaps in clinical trial data and observational studies, making it a focus for regulators. 3.) Framework Proposal: The paper advocates for a unified framework for regulators, grounded in evolving standards of fit-for-purpose PGHD, to maximize its utility in supporting drug and treatment applications. 🌟 Dive into the findings and join the conversation on advancing the future of health data! here: https://lnkd.in/e97RzE_x 🌟 #HealthData #PGHD #Pharmacoepidemiology #RealWorldEvidence #DukeMargolis #HealthcareInnovation #MedicalResearch #PatientCare #DataQuality
Regulatory Fit-for-Purpose Considerations for Patient-Generated Health Data
healthpolicy.duke.edu
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Field Medical Director US Medical Affairs, Clinical Microbiologist, Editor at ASM Spectrum, Clinical & Translational Science PhD. Opinions are mine and not that of my employer.
#TheScienceImReading Very excited to share our brand new publication out in ASHE today! This article, lead authored by MPH trainee Darin Robillard, PMP (University of Utah Division of Public Health) is a narrative review of antimicrobial resistance surveillance data flow in the US. 🌟 What are important considerations for susceptibility test data collection and sharing in the clinical microbiology laboratory? ✨ How are data shared from the clinical lab to local and regional public health labs? How are data shared with larger public health organizations? ⭐ What role do industry-led surveillance programs play? 🤩 What is needed to optimize data sharing and surveillance for AMR in the future? Special thanks to our amazing co-authors Alexander Sundermann, DrPH, CIC, FAPIC and Brian Raux, as well as our public health partners who dedicated time and energy to speaking with us and educating us about all things AMR surveillance. Read more HERE: https://lnkd.in/grVY8hnz #LabWeek2024 American Society for Clinical Laboratory Science American Society for Microbiology APHL - Association of Public Health Laboratories Society for Healthcare Epidemiology of America (SHEA)
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Strategies for communicating scientific evidence on healthcare to managers and the population Health evidence needs to be communicated and disseminated in a manner that is clearly understood by decision-makers. As an inherent component of health knowledge translation, communicating results of scientific studies, effects of interventions and health risk estimates, in addition to understanding key concepts of clinical epidemiology and interpreting evidence, represent a set of essential instruments to reduce the gap between science and practice. The advancement of digital and social media has reshaped the concept of health communication, introducing new, direct and powerful communication platforms and gateways between researchers and the public. Health evidence needs to be communicated and disseminated in a manner that is clearly understood by decision-makers, especially in settings that demand rapid responses. As an inherent component of health knowledge translation, communicating results of scientific studies, effects of interventions and health risk estimates, in addition to understanding key concepts of clinical epidemiology and interpreting evidence, represent a set of essential instruments to reduce the gap between science and practice. Strategies for communication of evidence in health have the initial goal of increasing the understanding of the results of scientific research and should cover products, actions and approaches aligned to the needs of the manager (facing the demands for healthcare services) and the population (reliable information based on the best scientific evidence available). Nevertheless, the ultimate expected outcome of any effective communication, addressed to specific audiences, would be its clinical benefit (when considering individual health) and/or positive impact on health systems and organizations (when considering public health). https://lnkd.in/d_NDUtvh #healthcare #HCP #EBM #Scienteficcommunication #EIP
Strategies for communicating scientific evidence on healthcare to managers and the population: a scoping review - Health Research Policy and Systems
health-policy-systems.biomedcentral.com
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Lessons from COVID-19: Preparing for future pandemics means looking beyond the health data The-14 The Conversation Canada #Health #Pandemic #COVID19 #Epidemiology #WHO #Lockdown #PandemicRestrictions #EmergingViruses #InfectionsDiseases #FuturePandemics #LessonsLearned #PublicHealth #PolicyAnalysis
Lessons from COVID-19: Preparing for future pandemics means looking beyond the health data
https://the-14.com
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Unveiling Insights into Chlamydia: Bridging Gaps through Comprehensive Consulting Services For More Insights: https://lnkd.in/dRcn6n-U Description: 🔬✨ Explore the dynamic world of #ChlamydiaDisease with our cutting-edge Consulting Services! From Disease Landscape and Overview to Drug Insights and Clinical Trial Assessment, we provide a holistic approach to empower your healthcare journey. 🚀 Embark on a transformative experience with our Product Launch Services, ensuring a seamless introduction of new solutions. Our expertise spans across New Product Launch Services, Product Development Services, and Drug Launch Strategies, ensuring your innovations reach their full potential. 👩⚕️💡 Dive deep into Healthcare Consulting Services tailored to your needs. We specialize in #DiseaseInsights, Treatment Gaps Identification, and Epidemiology Studies, offering a comprehensive understanding of Chlamydia and its impact on public health. 💊🌐 Navigate the complexities of #drugdevelopment with our services, including Clinical Trial Management, Post Launch Services, and Product Pipeline Analysis. From Regulatory Consulting to Commercial Strategy Analysis, we're your trusted partner in every step of the journey. 💰⚖️ Uncover the key to success with our expertise in Pricing and #marketaccess , Price Reimbursement, and Market Access strategies. Our services extend to Product Portfolio Analysis, ensuring a strategic and impactful presence in the market. 📈✅ With a focus on Disease Burden and #regulatorycompliance , our Health Consultants pave the way for a healthier future. Join us in redefining healthcare through innovation, insights, and impactful strategies. #Chlamydia #HealthcareConsulting #DrugDevelopment #ProductLaunch #MarketAccess #DiseaseLandscape #InnovationInHealthcare #ConsultingServices #HealthConsultant #ClinicalTrials #RegulatoryCompliance
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Owner | Public Health | Clinical Research | Host biostat done 4u podcast| Data to patient care decision.
Survival is more than just Kaplan Meier curve Today, we’re diving into the heart of survival analysis—understanding hazard and survival functions. Think of these as your tools to understand patient outcomes over time. What’s a Hazard Function? The hazard function is like a heart monitor for your study. It tells you the rate at which patients experience events (like relapse or recovery) at any given time. Imagine it showing you how the risk of an event changes over time. What’s a Survival Function? The survival function is your guide to the probability of patients surviving past a certain time. It’s like having a progress report on how many patients are still doing well as time goes by. Why It Matters These functions help you predict outcomes and tailor treatments. By understanding the risk and survival over time, you can make more informed decisions for your patients. Stay tuned! Tomorrow, we’ll explore other important ways to look at survival data. Keep learning and improving patient care! -------------------- If this is the first time you have seen my post, Hi, I am Nouran, a pharmacist by education, with a master's in Epidemiology, a Ph.D in Biostatistics and about two decades of experience serving the industrial and public health sectors making informed patient care decisions. Besides being a mother of 4 and my medical/ clinical research companies that serve pharma and ranked academic institutes, I am a biostatistics nerd! Follow me for more posts!
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