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Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

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Rosanna Tarricone, Oriana Ciani, Aleksandra Torbica, Werner Brouwer, Georges Chaloutsos, Michael F Drummond, Nicolas Martelli, Ulf Persson, Reiner Leidl, Les Levin, Laura Sampietro-Colom & Rod S Taylor. (2020) Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective. Expert Review of Medical Devices 17:10, pages 993-1006.
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Frank Hulstaert, Céline Pouppez, Célia Primus-de Jong, Kathleen Harkin & Mattias Neyt. (2023) Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions. Orphanet Journal of Rare Diseases 18:1.
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Nahar Singh. 2023. Handbook of Metrology and Applications. Handbook of Metrology and Applications 557 564 .
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Nneka C. Onwudiwe, Richard Charter, Bruce Gingles, Payam Abrishami, Henry Alder, Ameet Bahkai, Diane Civic, Melodi Kosaner Kließ, Chantale Lessard & Carla L. Zema. (2022) Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An ISPOR Medical Devices and Diagnostics Special Interest Group Report. Journal of Medical Devices 16:3.
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Sandor Kovács, Zoltán Kaló, Rita Daubner‐Bendes, Katarzyna Kolasa, Rok Hren, Tomas Tesar, Vivian Reckers‐Droog, Werner Brouwer, Carlo Federici, Mike Drummond & Antal Tamás Zemplényi. (2022) Implementation of coverage with evidence development schemes for medical devices: A decision tool for late technology adopter countries. Health Economics 31:S1, pages 195-206.
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Hayley Hill, Ruchi Mittal & Tracy Merlin. (2022) Evidence‐based funding of new imaging applications and technologies by Medicare in Australia: How it happens and how it can be improved. Journal of Medical Imaging and Radiation Oncology 66:2, pages 215-224.
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Chris Cooper, Sarah Dawson & Carol Lefebvre. (2021) Searching for medical devices – Practical guidance. Research Synthesis Methods 13:1, pages 144-154.
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Jana RozmarinováBarbora Říhová. (2021) Health Technology Assessment of the Medical Devices: A Case Study from the Czech Republic. NISPAcee Journal of Public Administration and Policy 14:2, pages 253-272.
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Carl Rudolf Blankart, Florian Dams, Hannah Penton, Zoltán Kaló, Antal Zemplényi, Kosta Shatrov, Rowan Iskandar & Carlo Federici. (2021) Regulatory and HTA early dialogues in medical devices. Health Policy 125:10, pages 1322-1329.
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Emily J. Hotton, Sophie Renwick, Erik Lenguerrand, Julia Wade, Tim J. Draycott, Joanna F. Crofts & Natalie S. Blencowe. (2021) Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review. European Journal of Obstetrics & Gynecology and Reproductive Biology 262, pages 166-173.
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Milena Vainieri, Francesca Ferrè & Stefania Manetti. (2021) An Integrated Framework to Measure the Performance of Inter-Organizational Programme on Health Technology Assessment. Sustainability 13:7, pages 3873.
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Rita Daubner-Bendes, Sándor Kovács, Maciej Niewada, Mirjana Huic, Michael Drummond, Oriana Ciani, Carl Rudolf Blankart, Olena Mandrik, Aleksandra Torbica, John Yfantopoulos, Guenka Petrova, Malwina Holownia-Voloskova, Rod S. Taylor, Maiwenn Al, Oresta Piniazhko, László Lorenzovici, Rosanna Tarricone, Antal Zemplényi & Zoltán Kaló. (2021) Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges. Frontiers in Public Health 8.
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Carla Rognoni, Matteo Tozzi & Rosanna Tarricone. (2020) Endovascular versus surgical creation of arteriovenous fistula in hemodialysis patients: Cost-effectiveness and budget impact analyses. The Journal of Vascular Access 22:1, pages 48-57.
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Vinayak Smith, Ritesh Warty, Amrish Nair, Sathya Krishnan, Joel Arun Sursas, Fabricio da Silva Costa, Beverley Vollenhoven & Euan Morrison Wallace. (2019) Defining the clinician’s role in early health technology assessment during medical device innovation – a systematic review. BMC Health Services Research 19:1.
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Sabine Fuchs, Britta Olberg, Matthias Perleth, Reinhard Busse & Dimitra Panteli. (2019) Testing a new taxonomic model for the assessment of medical devices: Is it plausible and applicable? Insights from HTA reports and interviews with HTA institutions in Europe. Health Policy 123:2, pages 173-181.
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Carla Rognoni, Oriana Ciani, Silvia Sommariva & Rosanna Tarricone. (2018) Cost–effectiveness analysis of treatments involving radioembolization in intermediate-stage hepatocellular carcinoma. Journal of Comparative Effectiveness Research 7:3, pages 209-221.
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Petra Schnell-Inderst, Theresa Hunger, Annette Conrads-Frank, Marjan Arvandi & Uwe Siebert. (2018) Recommendations for primary studies evaluating therapeutic medical devices were identified and systematically reported through reviewing existing guidance. Journal of Clinical Epidemiology 94, pages 46-58.
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Petra Schnell-Inderst, Theresa Hunger, Annette Conrads-Frank, Marjan Arvandi & Uwe Siebert. (2018) Ten recommendations for assessing the comparative effectiveness of therapeutic medical devices: a targeted review and adaptation. Journal of Clinical Epidemiology 94, pages 97-113.
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Carla Rognoni, Oriana Ciani, Silvia Sommariva & Rosanna Tarricone. (2017) Real-World Data for the Evaluation of Transarterial Radioembolization versus Sorafenib in Hepatocellular Carcinoma: A Cost-Effectiveness Analysis. Value in Health 20:3, pages 336-344.
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Sabine Fuchs, Britta Olberg, Dimitra Panteli, Matthias Perleth & Reinhard Busse. (2017) HTA of medical devices: Challenges and ideas for the future from a European perspective. Health Policy 121:3, pages 215-229.
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Oriana Ciani, Britni Wilcher, Anoukh van Giessen & Rod S. Taylor. (2017) Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments. Health Economics 26, pages 13-29.
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Rosanna Tarricone, Giuditta Callea, Marko Ogorevc & Valentina Prevolnik Rupel. (2017) Improving the Methods for the Economic Evaluation of Medical Devices. Health Economics 26, pages 70-92.
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Rosanna Tarricone, Aleksandra Torbica & Michael Drummond. (2017) Challenges in the Assessment of Medical Devices: The MedtecHTA Project. Health Economics 26, pages 5-12.
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Myriam Lingg, Kaspar Wyss & Luis Durán-Arenas. (2016) Effects of procurement practices on quality of medical device or service received: a qualitative study comparing countries. BMC Health Services Research 16:1.
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Michael Drummond, Rosanna Tarricone & Aleksandra Torbica. (2016) Incentivizing research into the effectiveness of medical devices. The European Journal of Health Economics 17:9, pages 1055-1058.
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Rosanna Tarricone, Paola Roberta Boscolo & Patrizio Armeni. (2016) What type of clinical evidence is needed to assess medical devices?. European Respiratory Review 25:141, pages 259-265.
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Oriana Ciani, Patrizio Armeni, Paola Roberta Boscolo, Marianna Cavazza, Claudio Jommi & Rosanna Tarricone. (2016) De innovatione: The concept of innovation for medical technologies and its implications for healthcare policy-making. Health Policy and Technology 5:1, pages 47-64.
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Cinzia Valzania, Aleksandra Torbica, Rosanna Tarricone, Francisco Leyva & Giuseppe Boriani. (2016) Implant rates of cardiac implantable electrical devices in Europe: A systematic literature review. Health Policy 120:1, pages 1-15.
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Oriana Ciani, Carlo Federici & Rosanna Tarricone. 2016. XIV Mediterranean Conference on Medical and Biological Engineering and Computing 2016. XIV Mediterranean Conference on Medical and Biological Engineering and Computing 2016 1345 1348 .
Oriana Ciani, Britni Wilcher, Carl Rudolf Blankart, Maximilian Hatz, Valentina Prevolnik Rupel, Renata Slabe Erker, Yauheniya Varabyova & Rod S. Taylor. (2015) HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES: A SURVEY OF NON-EUROPEAN UNION AGENCIES. International Journal of Technology Assessment in Health Care 31:3, pages 154-165.
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