RWE4Decisions

Meet the co-moderators of the RWE4Decisions Webinar! 📅 On 9 April, from 15:00 to 16:30 CEST, our upcoming webinar will be chaired by Eric Sutherland, Senior Health Economist OECD-OCDE, and Karen Facey, from the RWE4Decisions Secretariat. Bringing extensive expertise in health data policy and real-world evidence, our co-moderators will ensure a dynamic exchange of insights, guiding the conversation from high-level policy developments to practical steps for an effective and interoperable health data ecosystem in Europe. ✍🏻Sign up here and stay tuned for more updates: https://lnkd.in/etCXNBKe #EHDS #RWE #HealthData #HTA

📢 Save the date! 📆The first RWE4Decisions Webinar of 2025 is taking place on 9 April, from 15:00 to 16:30 CEST! With the European Health Data Space (EHDS) now moving into implementation phase, how can we turn policy into practice to support real-world evidence (RWE) for HTA/Payer decisions? This webinar will explore key challenges and solutions in implementing the EHDS, including: 🔹 Building effective health data-sharing systems 🔹 Ensuring interoperability and governance for secondary data use 🔹 Learning from national and EU-level initiatives that are paving the way for EHDS implementation and advancing the use of health data across Europe 📝 Don’t miss out & register now: https://lnkd.in/etCXNBKe 🔜 Stay tuned for speaker updates and more details! #EHDS #RealWorldEvidence #HTA #HealthData

📢 Call for Experts in Paediatric Clinical Trials by conect4children conect4children.eu and conect4children.org are seeking clinical paediatric experts to join its European initiative, which focuses on supporting the development of new therapies for the paediatric population. Experts will provide strategic feasibility advice to pharmaceutical companies and academic sponsors.    This opportunity arises only once every two years. If this aligns with your expertise, please consider applying by 21 February 2025. 🔗 Additional details and the application form: https://lnkd.in/djRTe_sf   Feel free to share with colleagues who may be interested.    #PaediatricResearch #ClinicalExperts #MethodologicalExperts #c4c #c4c-S

📝 Exciting news: our latest paper, “Planning Post-Launch Evidence Generation: Lessons from France, England and Spain” has been published in the Clinical Pharmacology and Therapeutics Journal! The paper examines Post-Launch Evidence Generation (PLEG) systems in France, Spain, and England, drawing insights from a RWE4Decisions Roundtable and a HTAi panel in 2024. While there are differences in the products to which PLEG is applied and the way it is operationalized, there are many common challenges experienced across systems and by all stakeholders concerning early anticipation of PLEG and streamlining data collection. Our findings suggest value in improving scientific advice processes and international collaboration to discuss key data gaps early and ensure efficient and effective evidence collection that improves the speed and quality of reimbursement and pricing decisions. We extend our deepest thanks to the co-authors: Seamus Kent, Carlos Martín Saborido, Catrin Austin, Steve Williamson, and Joshua Ray, Karen Facey, Francois Meyer, Alina Pavel. We also thank and acknowledge the support of Camille Thomassin, Judith Fernandez and Serena Rama. 🔗 We invite you to read the article here: https://lnkd.in/dfaWxFVq or find the key learnings summarised below!  #PLEG #CPTJournal #ASCPTJournalFamily

Real-World Evidence (RWE) taking centre stage in EU health policy discussions! 🎯🇪🇺   💡 Last week, six Horizon Europe-funded projects presented their work on harnessing RWE to support healthcare decision-making at the Multi-Stakeholder Workshop on RWD in regulatory & HTA decision-making in Bonn!   From More-EUROPA’s focus on registries, to ONCOVALUE’s efforts in standardising hospital data for cancer care, and Real4Reg’s use of AI across the product lifecycle, these projects demonstrate the increasing role of RWE in shaping HTA and Payer decisions. 📊   🔎 It’s encouraging to see the EU fostering collaboration in this space, but the discussion also raised a key challenge: ensuring these efforts align with the needs of decision-makers. With several projects engaging HTA bodies and payers and developing new methodologies, there’s an opportunity to strengthen the link between research and regulatory impact.   👥 This is why RWE4Decisions brings stakeholders together for meaningful multi-stakeholder diaogues, driving a more impactful and coordinated approach to RWE in regulatory and reimbursement decisions.   Great to see the momentum continuing, and we look forward to furthering these discussions to ensure RWE contributes to a more robust and evidence-driven approach in Europe! 👏   #RealWorldEvidence #HTA #HorizonEurope #DataForDecisions

🗄️Curious to learn more on how the #EHDS will improve healthcare delivery, support R&I, and be enforced nationally by digital health authorities and health data access bodies?   🏥The European Health Policy Platform (EUHPP) is organising a session of three webinars addressed to healthcare providers, patient organisations, system manufacturers, secondary data users and national enforcers interested in the forthcoming implementation of the EHDS Regulation.   🔗Join the EUHPP on • 18 February (11:00-12:30 CET) for a webinar on Primary Use of health data and Electronic Health Record Systems: https://lnkd.in/dQrJHViZ • 27 February (15:30-17:00 CET) for a session on Secondary Use of health data: https://lnkd.in/dEsih7Cn • 6 March (10:00-11:30 CET) for a webinar on implementation and governance: https://lnkd.in/dXrxf5-2   💽 The recent Council adoption of the EHDS Regulation is the latest milestone in the journey to integrate #RealWorldEvidence into regular practices of secondary use and support research and innovation in the EU.   #HTA #EHDS #healthdata #secondaryuse #RWE

RWE4Decisions has been recognised for its significant contributions to the development of Real-World Evidence 👇 (slide 18) These slides provide a great overview of RWE use for HTA/Payer purposes, showing their increased acceptance in decision-making to complement RCTs. The overview also reflects the RWE4Decisions pillars to shape robust RWE to inform pricing and reimbursement decisions 👉 https://lnkd.in/esHZzXYB

"𝐀 𝐮𝐧𝐢𝐭𝐞𝐝 𝐞𝐟𝐟𝐨𝐫𝐭 𝐬𝐮𝐩𝐩𝐨𝐫𝐭𝐞𝐝 𝐛𝐲 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬 𝐢𝐬 𝐭𝐡𝐞 𝐤𝐞𝐲 𝐭𝐨 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐬𝐮𝐜𝐜𝐞𝐬𝐬.” Rounding off our Stakeholder Action series, Matti Aapro MD underlined the importance of dialogue and close collaboration between patients and clinical teams with this call to action. Additionally, he shared with us his key three Actions for clinical teams ⬇️ 4.2 EU clinical networks and clinical trials collaborative groups (such as European Reference Networks, the EU cancer mission networks, the European Organisation for Research and Treatment of Cancer and other disease specific study groups) should systematically involve patients to collect patient relevant outcomes including nutritional status and co-morbidities, and collaborate with regulators and Payer/health technology assessment (HTA) bodies to ensure data collection systems are fit for all purposes, including HTA requirements pre and post launch. 4.4 Clinical networks and study groups should advise on the most suitable and efficient way for health systems to collect real-world data (RWD) to avoid multiplicity of data entry and clarify the support clinical teams require to collect good quality RWD. 4.5 Clinical networks and clinical trials collaborative groups should encourage health systems to involve clinical teams and patients in the design of data collection systems and associated governance structures to ensure processes are efficient and clarify the support clinical teams require to collect good quality real world data. We invite you to also share your key three actions with us, their impact in your day-to-day life, and any implementation stories you have collected. Consult all of the actions on the RWE4Decisions Website: https://lnkd.in/dHk93NaG #ClinicalTeams #RWE #RWD

🤔 In the run up to the implementation of the European Health Data Space (EHDS), questions about how it will work in practice are naturally arising. The TEHDAS2 joint action has been entrusted with the creation of a series of guidelines and technical specifications to help data users, data holders, and health data access bodies make use of the secondary use of health data, a pivotal aspect of the EHDS. The first set of these guidelines, containing four documents focused on data description, national metadata catalogues, data access and requests, and secure processing environments, were presented at the TEHDAS2 Stakeholder Forum on the 30th of January 2025. 💬 These EHDS guidelines are open for 𝐩𝐮𝐛𝐥𝐢𝐜 𝐜𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐭𝐢𝐨𝐧 𝐮𝐧𝐭𝐢𝐥 𝐭𝐡𝐞 28𝐭𝐡 𝐨𝐟 𝐅𝐞𝐛𝐫𝐮𝐚𝐫𝐲, to ensure that the final outputs meet the needs of citizens, health professionals and regulators. Have your say here: https://lnkd.in/gzrHNYXg. #EHDS #HealthData #TEHDAS2

“𝗧𝗿𝗮𝗻𝘀𝗽𝗮𝗿𝗲𝗻𝗰𝘆 𝗮𝗻𝗱 𝘁𝗿𝘂𝘀𝘁 𝗮𝗿𝗲 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗳𝗼𝗿 𝗿𝗲𝗴𝗶𝘀𝘁𝗿𝘆-𝗯𝗮𝘀𝗲𝗱 𝗱𝗮𝘁𝗮 𝘁𝗼 𝗯𝗲 𝘂𝘀𝗲𝗱 𝗶𝗻 𝗱𝗲𝗰𝗶𝘀𝗶𝗼𝗻-𝗺𝗮𝗸𝗶𝗻𝗴, 𝘄𝗵𝗶𝗰𝗵 𝗰𝗮𝗻 𝗼𝗻𝗹𝘆 𝗯𝗲 𝗳𝗼𝘀𝘁𝗲𝗿𝗲𝗱 𝗯𝘆 𝗱𝗶𝗮𝗹𝗼𝗴𝘂𝗲. 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗶𝗲𝘀 𝗻𝗲𝗲𝗱 𝘁𝗵𝗲 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝘆 𝘁𝗼 𝗲𝗻𝗴𝗮𝗴𝗲 𝗱𝗶𝗿𝗲𝗰𝘁𝗹𝘆 𝘄𝗶𝘁𝗵 𝗛𝗧𝗔 𝗯𝗼𝗱𝗶𝗲𝘀 𝗮𝗻𝗱 𝗽𝗮𝘆𝗲𝗿𝘀 𝘁𝗼 𝘀𝗵𝗮𝗿𝗲 𝘁𝗵𝗲𝗶𝗿 𝗽𝗿𝗼𝗴𝗿𝗮𝗺, 𝗮𝗻𝗱 𝗰𝗼𝗻𝘃𝗲𝗿𝘀𝗲𝗹𝘆 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗿𝗲𝗴𝗶𝘀𝘁𝗿𝗶𝗲𝘀 𝘁𝗼 𝘂𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱 𝘁𝗵𝗲 𝗛𝗧𝗔 𝗽𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲 𝗼𝗻 𝗱𝗮𝘁𝗮 𝗻𝗲𝗲𝗱𝘀.” This call to action to fellow disease registry holders has been shared by Victoria Hodgkinson, Chief Scientific Officer at Lumiio Inc., who has been deeply involved in revising the Stakeholder Actions to Generate Better RWE for HTA/Payers. But what are Victoria’s key tree actions for registry holders? Discover them below ⬇️ 6.1 Participate in multi-stakeholder dialogues about real-world evidence (RWE) generation for a specific medicine, or group of medicines, to discuss the potential for a disease registry to be used for regulatory and health technology assessment (HTA)/Payer purposes and ensure realism about data quality (availability for main outcomes and trade-offs for different data capture algorithms). 6.3 Engage with HTA/Payers and industry to explain the construct and purposes of disease registries, discuss their potential and limitations, and agree with HTA/Payers how disease registries and RWE studies will be assessed, building on existing tools (e.g. tools to report registry quality overall, and fitness-for-purpose evaluations for individual RWE studies). 6.4 Share and publish case studies of where real-world data (RWD) from disease registries has been used in to support HTA/Payer decision making. Transparency and collaboration have been important themes in the creation of the Actions, and they must be kept at the forefront of our mind in the process of implementation. Do you already have some implementation stories? Please share them with us! Have you not yet read the Stakeholder Actions, or would you like to refresh your memory? Find them on our website: 🔗 https://lnkd.in/d5XiAS6g #RWE #RegistryHolders #HTA #HealthData