Derk Arts, MD PhD

What are the implications of AI-enabled #clinicaltrials and #dataanalytics from a clinical development perspective?​ ​ ​KCR’s CMO, Anna Baran, and Principal Consultant, Dave Li, have an answer in their recent article, "​Generative AI-Enabled/Augmented Clinical Trials: The Road Ahead" in Applied Clinical Trials Magazine. ​ This article explores the transformative potential of generative artificial intelligence (#GenAI) in revolutionizing clinical trials and #drug #development. ​It highlights how GenAI, coupled with accelerated #computing, enables more efficient and #patient-centric approaches to decision-making and #data analysis in clinical settings. ​​ ​ Click here to read​ 👇   #KCRCRO #WhitePaper #AI #ClinicalResearch #Innovation #ClinicalTech #Research

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Your journey doesn't end with a drug release. Big data analytics and electronic health records (EHRs) unveil new therapeutic uses, enriching patient care and market potential. Big Data Power: Real-world evidence from EHRs offers diverse patient insights beyond clinical trials, identifying new drug applications. New Target Populations: Advanced analytics, like machine learning, pinpoint potential patient groups benefiting from existing drugs. Enhanced Marketing Strategies: Targeted studies, backed by real-world data, strengthen drug marketing and regulatory approval. Prioritizing Patient Privacy: We ensure ethical and responsible data usage, prioritizing patient privacy and security. At Kaolel, we specialize in assisting life science companies with leveraging big data for post-market drug studies. Our expertise drives innovation while maintaining patient privacy. Innovation meets responsibility as pharmaceutical companies leverage big data to revolutionize post-market drug studies. Together, we're shaping a healthier future. #BigData #Pharmaceuticals #pharma #HealthcareInnovation #PatientCare #EHR #drug #postmarket #data

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AI and data go hand in hand, wouldn't you agree? On the podcast, Dimitry Tran, co-founder and CEO of Harrison.ai, highlights the crucial importance of health data – coining it "the new uranium." The delicate nature of health data means that once its primary use is complete, many are hesitant to utilise it further. However, AI cannot function without data. The key is to handle this data with caution, ensuring it can be refined into something that supports AI and drives healthcare innovation. 🎧 Listen to the full episode to hear Dimitry delve into the detail: https://lnkd.in/eq-f2DjD #heathtech #digitalhealth #thehealthtechpodcast #podcast

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Check out the latest report from #ISPOR co-authored by @Scott Ramsey on assessing RWE from EHR for HTA! The report provides guidance on data delineation and data fitness for purpose, and recommendations for HTA agencies and policymakers to improve the use of EHR-derived data over time. Learn more here: https://lnkd.in/g-ebCPZe #RWE #HEOR outcomesresearch #curtahealth #EHR #HTA #healthtechnologyassessment

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Read about the essential steps and considerations for exporting clinical trial data in the Study Data Tabulation Model (SDTM) format from an Electronic Data Capture (EDC) system here: https://hubs.li/Q02ySqBX0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #SDTM

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How is Carevive SMARTData™ different from other oncology datasets on the market? Carevive has developed an industry-leading set of cancer registries that are focused on the longitudinal patient experience, with more than 30 cancer types available. Not limited to EMR and claims data, Carevive SMART DATA™ also features weekly patient reported outcomes data (PROs) on symptoms, physical function, quality of life, and treatment bother (Carevive SMARTData™) merged with a complete set of EMR-derived datapoints. As such, Carevive SMARTData™ empowers life science companies to put our data into action across the enterprise and improve the patient experience. Our datasets offer unparalleled insights into patient outcomes, clinical management, and health system impact, leading to many new use cases that can be explored. We out-license a growing set of cancer registries that are focused on the longitudinal patient experience in cancer, with more than 30 cancer types available.    We are excited to attend #ISPOR2024 from May 5th to 8th and present 4 posters showcasing how Carevive SMARTData™ in Action is providing valuable insights to the care of patients with multiple cancer types. Aaron Galaznik Emelly Rusli Keri Collette Mordecai Kramer Bruno Lempernesse #carevive #digitaloncology #cancer #cancercare   #oncology #patientreportedoutcomes #oncologydata   #clinicalinnovation #drugcommercialization #RWD #RWE #smartdata  

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Interested in cancer health outcomes data? #SEERMHOS is a large patient-centered data resource that offers rich opportunities to evaluate patient-reported survey data on quality of life, function, symptoms, effectiveness of care, and more! It links the NCI's Surveillance, Epidemiology and End Results (SEER) cancer registry with the Centers for Medicare & Medicaid Services' (CMS) Medicare Health Outcomes Survey (MHOS) of Medicare Advantage Organization enrollees. SEER-MHOS includes data from 1998-2021, with approximately 328,000 cancer patients from 22 SEER registries. It also includes nearly 1 million survey respondents without cancer in the same geographic areas to compare with the cancer patients. Learn more: https://lnkd.in/gam9xdsP To stay up to date on the data linkage, please join the SEER-MHOS Listserv: https://bit.ly/3uSckql 

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#ClinicalUtility is one of several product features that must be evaluated and shared to demonstrate a medical product’s value and lay the groundwork for product acceptance and adoption. In this blog post, we compare different assessment techniques and present a case study on clinical utility evidence development. Read more: https://lnkd.in/gu8hT2HR

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Article ✍🏻 | Transforming Healthcare with Patient-Centered Approaches!  Today, medical research and medicine, more than ever, are prioritizing patient-centered approaches.  📰 This article explores trends such as collaborative decision-making, precision medicine, and the empowering shift towards patients accessing their medical records and actively participating in their health management.  At the same time, it delves into the differences between Patient-Generated Health Data (PGHD), Real World Data (RWD) and Self-reported data. These different types of data, generated directly by patients themselves, hold immense potential to contribute to improved health outcomes and personalized care.  Dive into our latest article: "What are real world data (RWD) vs. patient generated data vs. Self-reported data?" 🚀    Read now 👉 https://lnkd.in/eMpxKXMs    #RWD #realworlddata #PGHD #Selfreporteddata 

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Transform your approach to healthcare data with Emids EPulseAI Data Co-Pilot! Say goodbye to the delays and complexities of traditional data analysis. Data Co-Pilot uses Generative AI to empower operational leaders with immediate, actionable insights directly from your data. Curious about trends in wait times, your major cost drivers, customer feedback, or identifying at-risk groups? Just ask Data Co-Pilot! Rest assured, your data remains secure within your IT environment, fully compliant with HIPAA and PIPEDA. Don't let valuable insights slip through the cracks. Discover how Emids Data Co-Pilot can empower you with immediate, actionable insights. #GenerativeAI #DigitalHealth #DataSecurity #HealthcareInnovation

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AI-Driven Biostatistics: Revolutionizing Clinical Trials 📢 Exciting Announcement! 📢 I am thrilled to introduce my new book, "AI-Driven Biostatistics: Revolutionizing Clinical Trials", now available on Kindle! 📚✨ In the rapidly evolving landscape of clinical research, the integration of artificial intelligence (AI) is transforming how we conduct and analyze clinical trials. This book delves into the immense possibilities of AI in biostatistics, offering insights that can significantly enhance the efficiency, accuracy, and depth of clinical trial analyses. 🌟 Key Highlights of the Book: Enhanced Data Analysis: Learn how AI algorithms can process vast amounts of clinical data swiftly and precisely, uncovering patterns and trends that might be missed by traditional methods. Predictive Modeling: Discover how AI can predict outcomes and patient responses, enabling more informed decision-making and personalized treatment plans. Automated Processes: Explore the automation of repetitive tasks, such as data cleaning and preliminary analysis, allowing biostatisticians to focus on more complex, value-added activities. Real-time Monitoring: Understand how AI-powered tools can provide real-time monitoring and adaptive trial designs, improving the flexibility and responsiveness of clinical trials. Ethical and Regulatory Considerations: Gain insights into the ethical implications and regulatory landscape of using AI in clinical trials, ensuring compliance and ethical integrity. Why This Book? Comprehensive Coverage: Whether you are a seasoned biostatistician or a clinical researcher, this book provides a thorough understanding of how AI can be leveraged to improve clinical trial outcomes. Practical Insights: With real-world examples and case studies, you'll see practical applications of AI in biostatistics, making complex concepts accessible and actionable. Future-ready Skills: Equip yourself with the knowledge and skills to stay ahead in the rapidly advancing field of clinical research. Join the AI Revolution in Biostatistics! As we stand on the brink of a new era in clinical research, the potential for AI to revolutionize biostatistics is immense. This book is not just a guide but a comprehensive resource to help you harness the power of AI in your work. 📖 Get your copy today and embark on a journey to the future of clinical trials! Let's shape the future of biostatistics together! #AI #Biostatistics #ClinicalTrials #HealthcareInnovation #NewBookRelease Feel free to share your thoughts and experiences in the comments below. I look forward to engaging with you all and discussing the incredible impact of AI in our field! Thank you for your support and happy reading! 📘💡

How can AI dramatically accelerate clinical research trials by creating patient cohorts in seconds? In this webinar, Lisa Arbogast, Mitchell Lee, and Shawn Namdar explore how Sigma & Snowflake accelerate research, streamline patient cohort creation, and mitigate risk to scale clinical research. This is an opportunity you will want to take advantage of! Register for this session here: https://lnkd.in/g44uZXxx

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We appreciate the additional depth from Ruth Reader and POLITICO on the topic of missing data in clinical AI and how eCART's predictive risk analytic handles missingness to better discern a hospitalized patient's condition. "A new AI product just approved by the FDA tries to make a virtue of that missing data, exploiting the gaps as a form of information itself." Read more in the third section: "The Health Benefits of Missing Data" #sepsis #heartfailure #copd #FDA #machinelearning https://lnkd.in/eT2wij_c

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Majority of AI clinical trials report positive outcomes, yet concerns over generalizability persist - https://lght.ly/o287hf5 #clinicaltrial #clinicaltrials #outcomes #ai

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In #oncology, #RWE plays a vital role in understanding clinical care by leveraging data from sources like EHRs and claims. While oncology trials often hinge on overall survival for approval, gauging treatment effectiveness in routine care leans more on clinician judgment than standardized criteria like RECIST. Previous studies have validated real-world measures such as real-world progression (rwP) and real-world response (rwR), furnishing invaluable insights. In this JAMA Network Open study, researchers from Genentech and Flatiron Health aim to compare clinical trial RECIST endpoints with clinician-documented rwR and rwP from #RWD, enhancing confidence in real-world outcome measures. Visit our website to learn more: http://spkl.io/60464f1MQ

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A model driven approach to integrating clinical workflows and decisions can be broken into 4 steps: 1️⃣The Narrative 2️⃣The Computational Independent Model 3️⃣The Platform Independent Model 4️⃣The Platform Specific Model Watch the full webinar on integrating clinical workflows and decisions to learn more about each step here: https://ow.ly/T9gH50P7Z8L #HealthIT #DigitalHealth #FHIR

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