Andrea Falleni’s Post

A Complete Guide to "𝐑𝐞𝐚𝐥-𝐰𝐨𝐫𝐥𝐝 𝐃𝐚𝐭𝐚" [PDF-Guide]   ⏩➤ 𝐂𝐥𝐢𝐜𝐤 𝐇𝐞𝐫𝐞 𝐭𝐨 𝐆𝐞𝐭 𝐏𝐃𝐅 𝐂𝐨𝐩𝐲: https://lnkd.in/dwn-dR7r   #Realworlddata (RWD) has become a powerful tool in the life sciences industry by pharmaceutical, #biotechnology, & medical device companies; #healthcare payers; healthcare providers; and other end users (academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies) to add value at every stage of the drug development #lifecycle from understanding unmet healthcare needs and defining the patient journey to supporting regulatory submissions and post-market studies, offering value to payers, and defining market strategies.   #RWD generated from #wearabledevices & mobile apps and novel clinical trials are transforming the future of the #healthcareindustry. The role of wearable devices is also emerging in collecting real-world data. Wearable devices are clinically useful for better monitoring real-time, long-term, dynamic & #pathological processes.   ✔𝐃𝐫𝐢𝐯𝐞𝐫𝐬:  1. Rising Awareness of Personalized Healthcare  2. Delay in #DrugDevelopment and the Consequent Increase in Development Costs  3. Growing Burden of #chronicdiseases  4. Shift toward Value-based Care    ⏩𝐓𝐫𝐞𝐧𝐝𝐢𝐧𝐠 𝐁𝐥𝐨𝐠: https://lnkd.in/dtGiBXy6 ✔𝐊𝐞𝐲 𝐏𝐥𝐚𝐲𝐞𝐫𝐬 : Anthem, Inc. (U.S.), IQVIA Holdings Inc. (U.S.), ICON plc (Ireland), PPD Inc. (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), Oracle Corporation (U.S.), PAREXEL International Corporation (U.S.)   #Rwd #oncology #emr #clinicaldata #genomics #biosensors #HealthData #ClinicalResearch #PatientData #HealthcareAnalytics #EHRData #EvidenceBasedMedicine #HealthTech #HealthcareInsights #MedicalData #HealthInformatics #PublicHealthData #PrecisionMedicine #HealthcareEvidence

Digital Health/ Medicine/ Therapeutics - same or different? When I first got really serious about Digital Health in 2019, before the pandemic hype, I was honestly confused by all the different terms being thrown around: Digital Health, SaMD, AI, digital medicine, eHealth, mHealth... 😣 How do they relate with each other? Are they the same ? Sometimes they are used interchangeably. Even one single term may have multiple definitions, understood differently by each stakeholder. One stat: the ISPOR Digital Health Special Interest Group has identified 142 unique definitions of umbrella terms in 2022! Understanding the difference between these terminologies is important because different regulations and perceived value apply to each category. How should we categorise these products in the first place? • by type of technology (software, robotic surgery...) ? • by function (clinical support, disease management...)? • by customer (patient-facing, clinician...)? • ...others? From the payers and policy-makers perspectives, we can broadly bucket the different digital health products into 3 main categories that reflect their value: • Digital Health, • Digital medicine, • and Digital Therapeutics. They are related, but distinct concepts within the broader landscape of technologies in healthcare: • Digital Health: Technologies and systems that engage consumers for lifestyle, wellness, and health-related purposes. (ex: lifestyle/wellness apps...) 🧘♀️ • Digital medicine: software and/or hardware products that measure and/or intervene in patient health (ex : remote patient monitoring, decision support software...)📳 • Digital Therapeutics: software intended to treat or alleviate a disease, by delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health (ex. App for insomnia or hypertension, VR & video game for children with ADHD...)💊 Differentiating these terms ensures that interventions are appropriately validated and used within the scope of their intended purpose. Digital Health might attract broader interest, while digital therapeutics may require more substantial investment due to the need for clinical trials and health economics studies for regulatory approval and reimbursement. Innovators need to make informed decisions about where to allocate resources for the appropriate studies/evidence accordingly to the category 💰 This approach has the merit to be simple and straightforward. It closely aligns with the claim and value of the health technology, especially for market access. 👉 How would you categorise digital health technologies? #DigitalHealth #MarketAccess #terminology

🔍Embracing Patient-Centricity: Transforming Clinical Trials for the Better!🔍 Gone are the days when clinical trials were solely focused on data and endpoints. The paradigm is shifting towards a more compassionate, inclusive, and patient-driven approach. Why is this shift so crucial, you ask? Let's explore: 🌟 Empowerment and Engagement: When patients are engaged, the quality of research improves, and trust between researchers and participants deepens. 🔬 Enhanced Protocol Design: By considering patient perspectives from the outset, trial protocols become more relevant and feasible. This reduces protocol amendments, accelerates recruitment, and ultimately speeds up the entire drug development process. Win-win for both patients and researchers! 🤝 Collaboration and Communication: Bridging the gap between researchers, healthcare providers, and patients leads to a shared understanding of goals and challenges. Transparent communication also helps manage expectations and any unforeseen issues that may arise. 💡 Innovations in Technology: The digital era offers tools that empower patients to actively participate in their care. Wearables, apps, and telemedicine are transforming how data is collected, making trials more convenient while ensuring continuous monitoring. 🌍 Global Impact: Patient-centric trials have the potential to be more inclusive, reflecting diverse demographics and real-world scenarios. This diversity leads to insights that are applicable on a global scale, benefiting populations worldwide. 📊 Data that Matters: When patients contribute to study design, the collected data becomes more meaningful. Patient-centric trials provide a richer context for understanding the real impact of treatments on patients' lives. Image from: https://lnkd.in/dP5QTiP3 #iheartresearch #clinicaltrials #drmarieibrahim #patientengagement

Let's talk about a big challenge: keeping patients engaged in clinical trials. Many patients struggle to stay involved due to several barriers. How can we make their experience better and keep them committed throughout the trial? The Problems: 🗓️Complex protocols and rigid schedules can be tough for patients to manage, leading some to drop out. 🚫Patients often aren't involved early in drug development, which means trial designs might not meet their needs. 🗣️Communication between pharma companies, healthcare providers, and patients** isn't always clear and open. 📋Conventional ways of collecting data can be inconvenient and overwhelming for patients. The Solutions: 📝Involve patients from the beginning using fun contests and feedback tools to shape trial plans. 🕒Create flexible protocols with visit schedules that suit patients' lives and consider their caregivers. 💡Improve communication by making sure everyone involved can share ideas and information easily. ⌚Use apps, wearables, telemedicine, and remote monitoring to collect data in ways that are easier and more comfortable for patients. 🌐Try decentralized trials with strong digital tools to make it simpler for patients to take part and for data to be collected. These changes focus on patients, aiming to boost their involvement and satisfaction in trials. In the end, this could lead to better and more inclusive drug development. #ClinicalTrials #PatientCare #HealthInnovation

The #MedTech industry is intensifying it's focus on connected health, with #LifeSciences aiming for over one-fifth of its revenue from these solutions within five years, according to the latest report from the Capgemini Research Institute.   Connected Health has gained momentum as a segment with increased adoption and more sophisticated solutions such as telemedicine platforms, clinical decision-support systems, and monitoring devices.   These solutions are enhancing patient support and operational efficiency. As an illustration, the engineering teams from Capgemini in France have developed with echOpen the stethoscope of the 21st century.   Now there is no need for complex costly machines to see inside a patient’s body; the ultra-portable and affordable probe directly connects to any smartphone to make ultrasound imaging available to all, and improves medical diagnosis and care worldwide.   This is only the beginning of this revolution with the ongoing integration of #GenAI technologies: over half of organizations are already piloting generative AI for interactions with patients and healthcare personnel.   Learn more about how Connected Health and the power of technology is redefining the healthcare revolution: https://lnkd.in/eAniZ7S8   Watch the full Echopen case study in the comments below.   #ConnectedHealth  #AI #HealthcareInnovation #MedicalTechnology #CapgeminiEngineering

Is it surprising to learn that only about 7% of patients complete clinical trials?    Before delving deeper into the underlying causes, I would have been taken aback by this statistic. Factors such as limited access to trial sites, concerns about potential side effects, fear of medical procedures, and insufficient support from primary care physicians contribute to patient attrition rates. Here are some ways in which we can boost that percentage, and make sure patients are comfortable enough to want to remain in our clinical trials: 1️⃣ Patient-Centric Trials: Studies reveal that trials crafted with patient involvement boast higher launch success rates and expedited recruitment processes. By placing patients at the heart of trial design, we enhance relevance and engagement. 2️⃣ Digital Advancements: The integration of eConsent, telemedicine, and wearable devices revolutionizes clinical research efficiency, streamlining processes and enhancing patient experiences. 3️⃣ Diversity and Inclusion: Prioritizing diversity, equity, and inclusion (DEI) in trial design ensures a comprehensive representation of patient experiences. This diversity enriches trial relevance and success, paving the way for more inclusive healthcare solutions. 4️⃣ Translation and Communication: Clear and accurate communication, alongside meticulous translation services, are pivotal in engaging diverse participants and ensuring their full understanding of the trial process. Embracing patient-centric approaches not only addresses the clinical trial enrollment gap but also fosters a culture of inclusivity and empowerment in healthcare research. Any thoughts? I'd love to hear them! ⬇  #PatientCentricity #ClinicalTrials #HealthcareInnovation 🚀 

📢 𝐏𝐫𝐨𝐟 𝐄𝐫𝐢𝐤 𝐊𝐨𝐟𝐟𝐢𝐣𝐛𝐞𝐫𝐠'𝐬 𝐈𝐧𝐚𝐮𝐠𝐮𝐫𝐚𝐥 𝐋𝐞𝐜𝐭𝐮𝐫𝐞 𝐨𝐧 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧𝐬 👨⚕️ Today is a significant day in digital health as we gather for Prof Erik Koffijberg's Inaugural Lecture at the University of Twente. 🌐 In his oration, prof Erik Koffijberg emphasises the importance of digital innovations like apps, smartwatches, and AI in creating affordable and humanised healthcare. The challenge is to evaluate their true value. 💡 Only 20% of innovations enhance both quality and affordability, making continuous evaluation crucial. Prof Koffijberg advocates for simulation models to keep pace with the rapidly evolving nature of digital innovations, ensuring efficient, context-dependent assessments. 📅 Today, at 16.00 hrs in the Waaier Building, we delve into 'Impact of Digital Health Innovations: optimisation through simulation.' More information on Prof Koffijberg's remarkable journey and oration is here: 👇 TechMed Centre - University of Twente | HTSR #DigitalHealth #Innovation #HealthcareRevolution #SimulationModels

"These #healthtechnologies cannot replace human connection and #HCP interaction, but AI-driven systems can augment the care journey to give personlaised support and guidance to patients, improving accessibility, and inclusivity, driving better health outcomes" I couldn't agree more!