Moe Alsumidaie

📌 How IDDI sets the standard in biostatistical analysis? At #IDDI, our team of expert statisticians combines both standard and innovative methods to deliver results that are not only accurate and reliable but also fully reproducible. Our approaches align with the latest recommendations from #regulatory agencies, ensuring top-notch quality and compliance. Whether you're at the helm of a startup #biotech or leading a multinational #pharmaceutical company, #IDDI is your go-to partner for #biostatistical analysis that meets the highest standards of excellence. 👉 Let's connect to discuss how our tailored biostatistical strategies can help accelerate your clinical trials: https://lnkd.in/ecxqJGqU #biometricscro #biostatistics #clinicaltrials #clinicalresearch #innovationinhealthcare #pharma #biotech #regulatorystatistics #fdaapproval

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In a fascinating report by IQVIA Institute for Human Data Science, the authors highlight that the reason oncology timelines are likely increasing is due to trial enrollment and endpoint complexity and number of subjects required. New solutions are needed to address this changing landscape. “This report sets out to characterize the need for clinical trial global diversification by assessing trends in enrollment timelines, trial characteristics, and country utilization over the past five years.” www.npowermedicine.com is uniquely positioned to provide needed infrastructure to oncology clinics to address clinical trial complexity. Get your copy of the report: https://lnkd.in/erWtB-qG #Clinicalresearch #clinicaltrials #oncology

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Our latest #vCOA publication is a real team effort, with contributions from eight Aparito authors! ✍️ Let's break down the core themes of "Video-based assessments of activities of daily living: generating real-world evidence in pediatric rare diseases". 🧬 Harnessing Video-Based Assessments to Transform Pediatric Rare Disease Management Rare diseases present unique challenges, especially in pediatric cases where the need for accurate and comprehensive monitoring of Activities of Daily Living (ADL) is crucial. Our study emphasizes the transformative potential of video-based assessments in capturing real-world evidence and enhancing the quality of life for children with rare diseases. 🎥 Introduction to Video-Based Assessments Video-based assessments allow the recording of ADL in real-life settings, offering a richer, more nuanced view of a patient's functional abilities than traditional patient-reported outcomes. This method can capture subtle changes and provide a more accurate reflection of how a patient is coping with their condition and responding to treatments. ➕ Advantages of Video-Based Assessments 1. Real-World Context: By leveraging smartphone apps, these assessments can be conducted in the comfort of the patient’s home, minimizing the stress associated with clinical environments. 2. Engagement: Families can actively participate in monitoring and documenting their child's progress, making the process more inclusive and supportive. 3. Objective Analysis: Video recordings can reduce subjective bias, providing a visual record that can be revisited and analyzed by multiple experts. ✅ Implementation and Validation The development of vCOAs requires rigorous validation to ensure reliability and accuracy. This involves: a) Co-Creation with Stakeholders: Engaging parents, caregivers, and key opinion leaders to ensure the assessments are relevant and user-friendly. b) Standardization of Tasks: Developing a set of standardized tasks that can be performed and recorded to track progress and treatment efficacy. c) Data Integrity and Security: Ensuring that video data is handled according to strict regulatory standards to maintain patient privacy and data quality. 🚀 Future Directions The integration of artificial intelligence (AI) in analyzing video data holds great promise. AI can automate analysis, providing real-time feedback and enhance assessment precision. Coupling video assessments with wearable technology can offer a multi-angle view, further improving the robustness of the data collected. ⌛ Conclusion Video-based assessments are poised to revolutionize the management of pediatric rare diseases by providing a more accurate, engaging, and patient-centered approach to monitoring and evaluating treatment outcomes. These methods will become more integrated and essential in #ClinicalTrials and everyday care. Would you like to know more? Read the complete paper here 👇 https://hubs.li/Q02zYxKw0

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How should healthcare providers analyze real world data (RWD) and real world evidence (RWE) to assess patient-reported outcomes, quality-of-life measures, functional status, and other relevant health indicators? How can organizations use AI to stratify populations? View our on-demand webinar to learn how RWD, RWE and AI/machine learning are poised to transform biopharma innovation and personalized care delivery, here: https://lnkd.in/g34WEuar #artificialintelligence #healthcare #webinar

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If you’re attending #CPHIMilan on October 9, join us for a deep dive into Oncology’s latest innovations. IQVIA expert Aurelio Arias will present ‘Exploring Emerging Innovations in Oncology”, where we will explore growth areas within Oncology, evaluate patient outcomes, discuss successful medicine launches, and delve into future clinical trials, manufacturing advancements, and off-patent opportunities. Don’t miss it! https://bit.ly/3Z85X3a #GlobalMarketInsights #OncologyInnovation #HealthcareAdvancements

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How can synthetic data change the way we approach clinical trials in oncology? What are the potential benefits of replacing real-world data with statistically generated datasets for external control arms? These questions lie at the heart of the ECLIPSE study, which compares the use of #synthetic real-world data (RWD) with actual patient data from a clinical trial to evaluate treatment effects. We've published the protocol for this study here. https://lnkd.in/gM8UH-vy The focus is on patients with metastatic non-small cell lung cancer (mNSCLC), specifically comparing nivolumab plus ipilimumab to nivolumab alone. The study aims to determine whether synthetic data can offer the same insights as real-world data while addressing privacy and data-sharing concerns. The significance of synthetic data extends beyond theoretical research, with recent legal developments in Utah providing new clarity on its use. Under the #Utah AI Policy Act (AI Act), synthetic data is now explicitly recognized as a form of de-identified data, enabling broader use without compromising privacy. This aligns with evolving best practices and sets the stage for rapid development in the field. As legal frameworks around synthetic data advance globally, its role in accelerating clinical trials and other types of clinical studies (real-world evidence) could become more prominent, allowing faster access to life-saving therapies while adhering to privacy regulations. We trust FDA, European Medicines Agency and other global regulators will be paying close attention to developments in this field. Many thanks to our co-authors and partners in this study protocol including Alind Gupta, Luke Segars and David Singletary from Subsalt, Johan Liseth Hansen and Kirk Geale from Quantify Research, Anmol Arora, Manuel Gomes, Sreeram Ramagopalan, Winson Cheung and Paul Arora #syntheticdata #oncologyresearch #realworldevidence #clinicaltrials #ECLIPSEstudy #externalcontrolarms #cancerresearch #dataprivacy #mNSCLC #generativemodels #healthinnovation #inkahealth #syntheticRWD #AIregulation #privacyprotection #datasharing #Clinicaltrial #statistics #datascience #UtahAIAct #Utah #syntheticdata #generativeai #CDA #NICE #ISPOR #FDA #EMA #DLSPH #Utoronto

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Digitising Clinical Trial Protocol Flow Chart...... Thank you to Tamer Chowdhury of Boehringer Ingelheim for delivering the session "Experimentation with Vision Large Language Models to Digitize Clinical Trial Protocol Flow Chart" at the 3rd Annual ACDM: Association for Clinical Data Management Symposium on Artificial Intelligence in Clinical Trials. Tamer demonstrated the potential of Vision LLMs in digitising clinical trial protocol flow charts, enabling automation, improved data management, and enhanced patient and study coordinator experiences. Marcus Schwabedissen of QFINITY Quality Management chaired this session. #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #edc #ACDM #AI #artificialintelligence

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Discover the #QPS Ultimate Guide to #Oncology! Dive into this comprehensive resource filled with the latest insights on #DrugDevelopment and #ClinicalResearch, and latest news from the QPS blog. Find the Guide here https://bit.ly/3VnQpWM, or contact us at [email protected]. 

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Oncology advanced practice providers are likely to encounter data from real-world evidence (RWE) studies in addition to data from randomized controlled trials (RCTs) in their clinical practice. RWE can complement data from RCTs and help guide shared decision-making by providing important information about treatment effectiveness in real-world clinical practice. Due to its increasing availability, it is important for APPs to understand RWE and how it can be considered in helping to inform appropriate treatment options for patient care. Advanced practice providers - read a primer on the interpretation, practical application and limitations of RWE for clinical use and in shared decision-making. This JADPRO article summarizes the fundamental aspects of RWE studies. Recently published studies of a CDK 4/6 inhibitor for patients with HR+/HER2- metastatic #BreastCancer were used to demonstrate how RWE studies may supplement RCT findings. https://bit.ly/3Sq2gSf

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The Friends of Cancer Research 's Pilot 2.0 study offers transformative insights into real-world data (#RWD). The study illustrates the potential and challenges in converting RWD into real-world evidence (RWE) by aligning analytic definitions of oncology endpoints). Link to the article in the comments below 👇 Key findings highlight the increased survival times for patients receiving PD-(L)1 therapies compared to standard chemotherapy. Median overall survival ranged from 10-17 months for standard chemotherapy and 12-18 months for PD-(L)1 therapies​​. Utilizing a collaborative protocol across multiple data partners, the study identified methodological best practices, emphasizing the need for common frameworks and variable definitions. This approach fosters consistency and reliability in RWD analysis​​. Real-world time to subsequent treatment (rwTTNT) and real-world time to treatment discontinuation (rwTTD) emerged as valuable early clinical endpoints. These metrics can complement traditional clinical trial data, providing robust evidence for regulatory purposes​​. Despite variations in data completeness and methodological approaches, the study underscores the importance of multistakeholder collaboration in generating high-quality RWE​​. At xCures, we are committed to advancing the integration of RWD into clinical research. By leveraging our AI-supported platform, we aim to enhance the quality and applicability of RWE, ultimately improving patient outcomes in oncology. #RealWorldData #OncologyResearch #PrecisionMedicine #AIinHealthcare 👉 Follow xCures Read our LinkedIn Newsletter: https://lnkd.in/dnNJV2ti https://xcures.com/ 👀 #HealthcareData

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Highlighting the Work of Leading #Oncology Experts in 2024 The year 2024 has been transformative for oncology, with remarkable advancements presented at global conferences such as ESMO - European Society for Medical Oncology, American Society of Clinical Oncology (ASCO), and AACR Journals This post highlights the work of some of the leading experts whose contributions are shaping the future of cancer care and offering new hope for patients worldwide. Artificial Intelligence (AI) in Cancer Care Dr. James Zou, Associate Professor of Biomedical Data Science at Stanford University, emphasized how AI is redefining oncology. His research focuses on developing machine learning algorithms to enhance the reliability and interpretability of AI in healthcare. AI-driven tools are streamlining early diagnosis, enabling personalized treatment planning, and improving real-time patient monitoring. These innovations are particularly impactful in managing rare and aggressive cancers. At the ESMO Congress 2024, Dr. Teresa Macarulla Mercadé from the Vall d'Hebron Institute of Oncology in Barcelona highlighted the transformative impact of AI on cancer care. AI-driven tools are enhancing early diagnosis and personalized treatment planning, particularly in rare and aggressive cancers. Insights from platforms like ONCOLOGYPRO emphasize how AI is reshaping the precision and efficiency of oncological treatments. Antibody-Drug Conjugates (ADCs) Dr. Carolyn Bertozzi, a prominent researcher at Stanford University, introduced new-generation ADCs targeting tumor-specific antigens. These therapies offer highly targeted treatments, with significant progress in addressing diseases like triple-negative breast cancer and advanced lymphomas. Liquid Biopsy Innovations Dr. Christina Curtis from Stanford University presented advancements in liquid biopsy technologies. These non-invasive diagnostic tools enhance early cancer detection, track tumor evolution, and help personalize treatment approaches in real time. These highlights underscore the impactful work of oncology experts who are advancing science and transforming cancer care. Their collective efforts are improving outcomes, extending survival, and redefining the patient experience. Which experts or breakthroughs have inspired you this year? Let’s discuss below. #OncologyFrontier #CancerResearch #MedicalInnovation #OncologyUpdates #CancerTreatment #PrecisionMedicine #Immunotherapy #AIinHealthcare #CancerDiagnosis #ClinicalResearch #CancerTherapies #TargetedTherapies #Biotechnology #LiquidBiopsy #AntibodyDrugConjugates #OncologyExperts #MedicalBreakthroughs #CancerCareAdvancements #InnovativeMedicine

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Discover the #QPS Ultimate Guide to #Oncology! Dive into this comprehensive resource filled with the latest insights on #DrugDevelopment, #ClinicalResearch, and the latest news from the QPS #blog. Find the Guide here https://bit.ly/3VnQpWM, or contact us at [email protected]

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We analyzed 90,000 conversational AI queries across eight agents and four brands. It's fascinating to see how HCPs and patients take a different approach with their questions. For example, HCPs dive deep into clinical data, asking about drug interactions and mechanisms of action. Patients focus on personal experiences, like side effects. Learn more in Duré Hussain's latest Swoop blog: https://lnkd.in/ekyY9BQh #PharmaMarketing #PatientEngagement #HCPCommunication

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🎯 At IDDI, #Biostatistics is at the heart of every clinical study, driving study design, protocol development, clinical data collection, data analysis, and reporting. #IDDI delivers optimal study designs, best practice randomization methods, regular independent checks of the #randomization balance, #CRF review, and timely statistical analysis in order to produce #clinicaltrial results that are scientifically accurate, validated, and reproducible. Talk to our experts today to discover how our advanced biostatistics service could help deliver your clinical trials leaner and faster: https://lnkd.in/eB33rd8b #biostaticstics #trialdesign #studydesigns #clinicaldataanalysis #clinicaldatamanagement #crfreview #RTSM #fda #statisticalanalysis

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Access real-world analyses drawn from the latest, longitudinal, physician-supplied data on oncology care in Europe. Download a Sample TherapyMonitor Report and Access European Oncology Analytics Data: https://ow.ly/EAxk50Sfq2E #Oncology #HealthcareAnalytics #RealWorldData

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The #QPS Ultimate Guide to #Oncology is here! Dive into this comprehensive resource filled with the latest insights on #preclinical and #clinical #DrugDevelopment and #ClinicalTrials. Find the Guide here https://bit.ly/3VnQpWM, or contact us at [email protected] #cancer

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When choosing a CRO, you'll likely look at a variety of factors, from budget to culture. Size is one element to take into account: here are three reasons why choosing a smaller CRO can boost your clinical trial. https://buff.ly/4caRzup #clinicaltrials #CRO #clinicalresearch #consultants

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What do Switzerland, CluePoints, and AI have in common? 🌍🌐 The ACDM AI Symposium, of course. Join industry leaders in Basel on June 24–25 to discuss real-world scenarios of AI in clinical trials, particularly in clinical data management, and examine their capabilities and limitations. Register now, and don’t be a stranger—message us to say hello! https://bit.ly/458JS5o #ACDM2024 #ClinicalTrials #ClinicalResearch #AIforClinicalTrials ACDM: Association for Clinical Data Management

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Discover the key clinical trial data clinical considerations in prescribing tazemetostat for the treatment of relapsed/refractory #FollicularLymphoma. Watch the full interview with Gilles Salles here: https://loom.ly/n6cdBYk #Lymphoma #LymSM

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