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  1. Article ; Online: R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 14.

    Bray, Benjamin D / Ramagopalan, Sreeram V

    Journal of comparative effectiveness research

    2024  Volume 13, Issue 1, Page(s) e230189

    Abstract: In this latest update we highlight: a publication from the US FDA regarding the definitions of real-world data (RWD) and real-world evidence (RWE); a publication from academic researchers on a demonstration project for target trial emulation; a ... ...

    Abstract In this latest update we highlight: a publication from the US FDA regarding the definitions of real-world data (RWD) and real-world evidence (RWE); a publication from academic researchers on a demonstration project for target trial emulation; a publication from the National Institute of Health and Care Excellence (NICE) on the 1 year anniversary of their RWE framework; and a publication from NICE and Flatiron Health on the utility of US RWD for initial UK health technology assessment decision making.
    MeSH term(s) United States ; Humans ; Biomedical Technology ; Research Personnel ; Technology Assessment, Biomedical ; United States Food and Drug Administration
    Language English
    Publishing date 2024-01-04
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2023-0189
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Does Industry Really Develop Less Medicines With Clinical Benefit?

    Moore, Alexander I G / Beattie, Alice / Ramagopalan, Sreeram V

    JAMA internal medicine

    2024  

    Language English
    Publishing date 2024-03-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2699338-7
    ISSN 2168-6114 ; 2168-6106
    ISSN (online) 2168-6114
    ISSN 2168-6106
    DOI 10.1001/jamainternmed.2024.0177
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.119: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  3. Article ; Online: Access in all areas? a round up of developments in market access and health technology assessment: part 4.

    Beattie, Alice / Treharne, Catrin / Ramagopalan, Sreeram V

    Journal of comparative effectiveness research

    2024  , Page(s) e240060

    Abstract: In this latest update, we look at recent developments in market access including the pricing agreement of ... ...

    Abstract In this latest update, we look at recent developments in market access including the pricing agreement of Libmeldy
    Language English
    Publishing date 2024-04-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2024-0060
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: The Blurred Lines of HTA Agency Decision Making.

    Mitchell, Grace / Ramagopalan, Sreeram V

    Medical decision making : an international journal of the Society for Medical Decision Making

    2023  Volume 44, Issue 1, Page(s) 3–4

    MeSH term(s) Humans ; Technology Assessment, Biomedical ; Decision Making ; Health Policy
    Language English
    Publishing date 2023-11-10
    Publishing country United States
    Document type Letter
    ZDB-ID 604497-9
    ISSN 1552-681X ; 0272-989X
    ISSN (online) 1552-681X
    ISSN 0272-989X
    DOI 10.1177/0272989X231208443
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1665: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article ; Online: R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11.

    Bray, Ben / Ramagopalan, Sreeram V

    Journal of comparative effectiveness research

    2023  Volume 12, Issue 5, Page(s) e230008

    Abstract: In this latest update we highlight a study from the REPEAT initiative that evaluates the reproducibility of real-world data studies, the publication of the HARPER Protocol Template developed by a joint ISPE/ISPOR taskforce, and discuss recent US FDA ... ...

    Abstract In this latest update we highlight a study from the REPEAT initiative that evaluates the reproducibility of real-world data studies, the publication of the HARPER Protocol Template developed by a joint ISPE/ISPOR taskforce, and discuss recent US FDA guidance on external control arms.
    MeSH term(s) Humans ; Reproducibility of Results ; Technology Assessment, Biomedical
    Language English
    Publishing date 2023-04-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2023-0008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 12.

    Bray, Ben / Ramagopalan, Sreeram V

    Journal of comparative effectiveness research

    2023  Volume 12, Issue 7, Page(s) e230092

    Abstract: In this latest update we highlight the final results from the RCT-DUPLICATE initiative, the publication of guidance from Haute Autorité de Santé (HAS), the joint viewpoint from the Institute for Quality and Efficiency in HealthCare (IQWIG) and the ... ...

    Abstract In this latest update we highlight the final results from the RCT-DUPLICATE initiative, the publication of guidance from Haute Autorité de Santé (HAS), the joint viewpoint from the Institute for Quality and Efficiency in HealthCare (IQWIG) and the Belgian HealthCare Knowledge Center, and a position from the European Organization for Research and Treatment of Cancer (EORTC). Finally, we discuss how the NICE RWE framework has been implemented to allow consideration of RWE external control arms.
    Language English
    Publishing date 2023-06-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2023-0092
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  7. Article ; Online: R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 13.

    Bray, Benjamin D / Ramagopalan, Sreeram V

    Journal of comparative effectiveness research

    2023  Volume 12, Issue 11, Page(s) e230141

    Abstract: In this latest update we highlight a report from the European Medicines Agency on their use of real-world evidence (RWE) in decision making, RWE reporting guidance from the Canadian Agency for Drugs and Technologies in Health and highlight some new data ... ...

    Abstract In this latest update we highlight a report from the European Medicines Agency on their use of real-world evidence (RWE) in decision making, RWE reporting guidance from the Canadian Agency for Drugs and Technologies in Health and highlight some new data demonstrating the value medicines for spinal muscular atrophy have brought patients.
    MeSH term(s) Humans ; Canada ; Technology Assessment, Biomedical
    Language English
    Publishing date 2023-09-15
    Publishing country England
    Document type Journal Article
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2023-0141
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  8. Article ; Online: EU HTA Joint Clinical Assessment: are patients with rare disease going to lose out?

    Castanon, Alejandra / Sloan, Rebecca / Arocha, Luisamanda Selle / Ramagopalan, Sreeram V

    Journal of comparative effectiveness research

    2024  , Page(s) e240052

    Language English
    Publishing date 2024-05-02
    Publishing country England
    Document type Editorial
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2024-0052
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Access in all areas? A round up of developments in market access and health technology assessment: part 3.

    Beattie, Alice / Treharne, Catrin / Ramagopalan, Sreeram V

    Journal of comparative effectiveness research

    2024  Volume 13, Issue 3, Page(s) e240009

    Abstract: In this latest update, we explore some of the key updates in market access over recent months including the UK's voluntary scheme for branded medicines pricing, access and growth (VPAG), the first drugs funded by the Innovative Medicines Fund in the UK ... ...

    Abstract In this latest update, we explore some of the key updates in market access over recent months including the UK's voluntary scheme for branded medicines pricing, access and growth (VPAG), the first drugs funded by the Innovative Medicines Fund in the UK and the Direct Access Scheme in France, and, finally, the new Institute for Clinical and Economic Review (ICER) value assessment framework in the USA.
    MeSH term(s) Humans ; Academies and Institutes ; Biomedical Technology ; Cost-Benefit Analysis ; France
    Language English
    Publishing date 2024-02-08
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2024-0009
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 15.

    Castanon, Alejandra / Bray, Benjamin D / Ramagopalan, Sreeram V

    Journal of comparative effectiveness research

    2024  Volume 13, Issue 5, Page(s) e240033

    Abstract: In this latest update we discuss real-world evidence (RWE) guidance from the leading oncology professional societies, the American Society of Clinical Oncology and the European Society for Medical Oncology, and the PRINCIPLED practical guide on the ... ...

    Abstract In this latest update we discuss real-world evidence (RWE) guidance from the leading oncology professional societies, the American Society of Clinical Oncology and the European Society for Medical Oncology, and the PRINCIPLED practical guide on the design and analysis of causal RWE studies.
    MeSH term(s) Humans ; Technology Assessment, Biomedical/methods ; Technology Assessment, Biomedical/economics ; Comparative Effectiveness Research/methods ; Comparative Effectiveness Research/economics ; Reimbursement Mechanisms ; Medical Oncology/economics ; Research Design
    Language English
    Publishing date 2024-03-28
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2024-0033
    Database MEDical Literature Analysis and Retrieval System OnLINE

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