Giuseppe Recchia
Verona, Veneto, Italia
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Gemelli Digital Medicine & Health — GDMH
We are happy to present a brand-new DIGI-MEd publication focused on the digitisation process in medicines’ clinical trials from a new European regulations’ perspective. IRCCS San Raffaele Hospital's Head of Clinical Research and Development and pharmacologist Professor Carlo Tomino discusses the recent improvements of #EuropeanRegulation on Interventional Drug Clinical Trials (Reg 536/2014) marking a transformative moment for Companies, Healthcare Facilities and Ethics Committees. Professor Tomino analyses the European Union's aim to improve the competitiveness of its clinical research processes by aligning them with global regulatory standards and ensuring high level standards of safety and transparency such as the publication of trials' authorizations, progress and outcomes. Moreover, he emphasises the potential of Italy to maintain its leading role in international research endeavours, since Italian researchers and clinical facilities are among the world's best. Ultimately, those promising perspectives represent an improved citizens' healthcare for the future, keeping in mind the commitment in using a comprehensible language for them during the care progresses. Read the article below to learn more about these important steps towards the digitisation's evolution! . #togethermovefirst #digitalmedicine #digitalhealth #clinicaltrials
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IOMED
👋Today starts the European Symposium OHDSI (Observational Health Data Sciences & Informatics) Symposium and we could not miss it. 👉📑IOMED as OHDSI collaborator chowcasing two posters: 🔹'Patient-Level data export based on ATLAS Cohort Definitions', by Marc Olivé, Sandra Pulido Griñón and Gabriel Maeztu 🔹'Improving real-world clinical data analysis: Integrating NLP-derived results with OMOP CDM', by Mónica Arrúe Gabaráin, Mariona Forcada Romeu, María Quijada López, Paula Chocrón and Gabriel Maeztu . 🤝Visit our posters and let's make connections. https://bit.ly/44F9kPY #OHDSISymposium #OHDSI #HealthcareInnovation #DataScience #IOMED #OHDSI #Healthcare #BigData
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BioRare Partners
🚀🌟 𝗡𝗲𝗮𝗿𝗶𝗻𝗴 𝗮 𝗠𝗮𝗷𝗼𝗿 𝗖𝗵𝗮𝗻𝗴𝗲 𝗶𝗻 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲! 🌟🚀 Starting January 2025, the EU's Joint Clinical Assessment (JCA) will transform the evaluation of health technologies, beginning with oncology medicines and Advanced Therapy Medicinal Products (ATMPs). The HTA Coordination Group (HTACG) has just outlined which types of products will be included in the first wave of the EU Joint Clinical Assessment, set to begin in January 2025. For more details, check out the official announcement: tinyurl.com/bdz43bjy. While this initiative aims to harmonize assessments and enhance patient access, further clarifications are needed to ensure smooth implementation. 🌍💊 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: 🔍 𝗦𝘁𝗿𝗲𝗮𝗺𝗹𝗶𝗻𝗲𝗱 𝗣𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀: The JCA provides a single clinical assessment for new medicines, alongside the European Medicines Agency (EMA) marketing authorization, avoiding duplication and speeding up patient access. 🔬 𝗖𝗹𝗲𝗮𝗿 𝗖𝗿𝗶𝘁𝗲𝗿𝗶𝗮 𝗳𝗼𝗿 𝗔𝗧𝗠𝗣𝘀 𝗮𝗻𝗱 𝗢𝗿𝗽𝗵𝗮𝗻 𝗗𝗿𝘂𝗴𝘀: 𝘈𝘛𝘔𝘗𝘴: Must meet Regulation (EC) No 1394/2007. 𝘖𝘳𝘱𝘩𝘢𝘯 𝘥𝘳𝘶𝘨𝘴: Evaluated based on Regulation (EC) No 141/2000. 📜🔬 📌 𝗕𝘂𝘁 𝘄𝗵𝗮𝘁 𝗮𝗯𝗼𝘂𝘁 𝗰𝗮𝗻𝗰𝗲𝗿 𝘁𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀? 𝗛𝗲𝗿𝗲'𝘀 𝘄𝗵𝗲𝗿𝗲 𝗶𝘁 𝗴𝗲𝘁𝘀 𝗶𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗶𝗻𝗴! 𝘐𝘯𝘤𝘭𝘶𝘥𝘦𝘥: Chemotherapy, biological therapies, and hormonal agents with anti-tumour effects. 𝘌𝘹𝘤𝘭𝘶𝘥𝘦𝘥: Agents for side effects, diagnostics, prevention, and symptom treatment without anti-tumour effects. 𝗟𝗼𝗼𝗸𝗶𝗻𝗴 𝗔𝗵𝗲𝗮𝗱: The successful implementation of the JCA is crucial for timely access to innovative therapies. The European Commission and industry stakeholders are working to finalize details, aiming to support healthcare systems with the latest technologies. Stay tuned for more updates on how these changes will shape the future of healthcare in the EU! #HealthcareInnovation #Oncology #AdvancedTherapies #PatientAccess #RegulatoryUpdates #EUHealthcare #JCALaunch
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Agency for Healthcare Research and Quality
Understanding the economic and clinical impact of #patient-centered (PC CDS) is an aspect of the implementation planning and needs assessment process to assess PC CDS value and can inform investment decisions. However, heterogeneity in the economic and clinical impacts assessed in evaluations of CDS can limit generalizability and the use of study findings to assess PC CDS value and inform investment decisions. A new report from the AHRQ Clinical Decision Support Innovation Collaborative (CDSiC) report summarizes examples of the impacts assessed via economic evaluations of decision support interventions, discusses challenges in assessing PC CDS value, and presents alternative considerations for assessing PC CDS value. https://lnkd.in/eq-MUPek
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Agency for Healthcare Research and Quality
Understanding the economic and clinical impact of #patient-centered (PC CDS) is an aspect of the implementation planning and needs assessment process to assess PC CDS value and can inform investment decisions. However, heterogeneity in the economic and clinical impacts assessed in evaluations of CDS can limit generalizability and the use of study findings to assess PC CDS value and inform investment decisions. A new report from the AHRQ Clinical Decision Support Innovation Collaborative (CDSiC) report summarizes examples of the impacts assessed via economic evaluations of decision support interventions, discusses challenges in assessing PC CDS value, and presents alternative considerations for assessing PC CDS value. https://lnkd.in/eq-MUPek
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AboutScience
#Pharmacovigilance (PV) ensures #drugsafety by identifying and preventing adverse effects. Challenges in non-profit clinical trials, such as limited resources and training, hinder effective PV. This article in Italian reports the outcomes of an Italian survey, which highlighted these issues, emphasizing the need for continuous professional development and adequate resources to enhance PV activities and maintain high research standards. | https://ow.ly/Plyh50SOTpX
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OncoDaily
Wonderful discussion of Global Geriatric Oncology on Cancer and Aging Research Group (CARG) - William Dale MD, PhD, FASCO Nicolò Matteo Luca Battisti SIOG - International Society of Geriatric Oncology EORTC - European Organisation for Research and Treatment of Cancer American Society of Clinical Oncology (ASCO) #Cancer #GeriatricOncology #CancerResearch #OncoDaily #Oncology
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es/iode
📃Scientific paper: Management of patients with severe asthma: results from a survey among allergists and clinical immunologists of the Central Italy Inter-Regional Section of SIAAIC Abstract: BACKGROUND: Asthma, and severe asthma in particular, is often managed within a specialized field with allergists and clinical immunologists playing a leading role. In this respect, the National Scientific Society SIAAIC (Società Italiana di Allergologia, Asma ed Immunologia Clinica), structured in Regional and Inter-Regional sections, interviewed a large number of specialists involved in the management of this respiratory disease. METHODS: A survey entitled “Management of patients with asthma and severe asthma” based on 17 questions was conducted through the SIAAIC newsletter in 2019 thanks to the collaboration between GlaxoSmithKline S.p.A. and the Inter-Regional Section of SIAAIC of Central Italy. RESULTS: Fifty-nine allergists and clinical immunologists participated to the survey, and 40 of them completed the entire questionnaire. Almost all of the specialists (88%) reported that asthma control was achieved in above 50% of their patients, even if only one third (32%) actually used validated clinical tools such as asthma control test (ACT). Poor adherence to inhaled therapy was recognized as the main cause of asthma control failure by 60% of respondents, and 2–5 min on average is dedicated to the patient inhaler technique training by two-thirds of the experts (65%). Maintenance and as-needed therapy (SMART/MART) is considered an appropriate approach in only a minority of the patients (25%) by one half of the respondents (52%). A high number of exacerbations despite... Continued on ES/IODE ➡️ https://etcse.fr/9Q3 ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.
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Enosium Life Science
🚀 Italy pushes for Decentralization and Real world evidence in its new Clinical Research Guidelines The Italian Medicines Agency (AIFA Agenzia Italiana del farmaco) has recently rolled out two pivotal guidelines that could reshape the framework for clinical trials and observational studies in Italy. These developments reflect a broader effort to streamline regulatory processes and bring the country's practices in line with European standards, but they also raise important questions about the challenges of implementation and the readiness of the healthcare ecosystem to adapt to these changes. 🔍 Regulatory Simplification & Decentralisation for Clinical Trials 🔍 This guideline is designed to simplify regulatory processes and introduce decentralisation elements in accordance with Regulation (EU) No. 536/2014. It covers critical aspects such as the use of service providers, home delivery of experimental medicines, and reimbursement for trial participants. By addressing organisational elements not fully covered at the national level, AIFA aims to ensure that European standards are effectively applied in Italy. However, the impact of these changes will largely depend on how well they are integrated into existing clinical practices. 🔍 Classification & Conduct of Observational Studies 🔍 AIFA has also updated its guidelines for observational studies, which play a key role in assessing drug safety and efficacy under real-world conditions. The new guideline, which replaces the 2008 version, incorporates the latest scientific and technical advancements, offering clearer instructions for conducting and evaluating these studies. It also underscores the importance of the Observational Studies Registry (RSO) for data collection and analysis. While this update is timely, the true test will be in how these guidelines influence the quality and consistency of observational research moving forward. 💡 These updates are a step in the right direction, signaling Italy’s commitment to aligning with European standards and advancing clinical research. However, the effectiveness of these guidelines will hinge on their practical implementation and the ability of all stakeholders to navigate the new regulatory landscape. The push for decentralisation and the emphasis on real-world data are encouraging, but they also require careful oversight to ensure that these initiatives enhance, rather than complicate, the clinical research process. Antoine Bassel Amer https://lnkd.in/eMtrE_Gd https://lnkd.in/e8AFBtk7
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