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  1. Article ; Online: Clinical trial publications: A sufficient basis for healthcare decisions?

    Eichler, Hans-Georg / Rasi, Guido

    European journal of internal medicine

    2020  Volume 71, Page(s) 13–14

    MeSH term(s) Delivery of Health Care ; Drug Evaluation ; Humans ; Periodicals as Topic ; Publications
    Language English
    Publishing date 2020-01-14
    Publishing country Netherlands
    Document type Journal Article ; Comment
    ZDB-ID 1038679-8
    ISSN 1879-0828 ; 0953-6205
    ISSN (online) 1879-0828
    ISSN 0953-6205
    DOI 10.1016/j.ejim.2019.11.022
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 2608: Show issues Location:
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  2. Article: Orphan drugs' clinical uncertainty and prices: Addressing allocative and technical inefficiencies in orphan drug reimbursement.

    Eichler, Hans-Georg / Kossmeier, Michael / Zeitlinger, Markus / Schwarzer-Daum, Brigitte

    Frontiers in pharmacology

    2023  Volume 14, Page(s) 1074512

    Abstract: Legislations incentivising orphan drug development and scientific advances have made orphan drugs pharma's high-end favourite for the past two decades. Currently, around 50% of new marketing authorizations are for orphan drugs. For third-party healthcare ...

    Abstract Legislations incentivising orphan drug development and scientific advances have made orphan drugs pharma's high-end favourite for the past two decades. Currently, around 50% of new marketing authorizations are for orphan drugs. For third-party healthcare payers ("payers") the rise of orphan drugs presents new challenges, including a high degree of uncertainty around clinical benefits and harms, a moderate effect size (for many orphan drugs), and a high price tag. The association of high clinical uncertainty and moderate effect sizes is not surprising in small target populations but in combination with high prices creates the risk of allocative and technical inefficiencies for payers. We here discuss and illustrate these risks. A combination of policies is needed for mitigation of allocative inefficiency: while there may be a rationale for higher prices for orphan than non-orphan drugs, a focus of pricing and reimbursement negotiations should include considerations of product profitability and of the consequences of orphan drug costs on the distribution inequality of medication costs for individual insured persons, coupled to knowledge generation from reimbursement contracts covering high-price orphan drugs that would benefit the wider patient community. Performance-based managed entry agreements could help to de-risk the economic consequences of clinical uncertainty and to mitigate technical inefficiency.
    Language English
    Publishing date 2023-01-26
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2023.1074512
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: A novel approach to boost drug development in paediatric oncology.

    Daems, Sam / Stevens, Hilde / Dewatripont, Mathias / Eichler, Hans-Georg / Goldman, Michel

    Nature reviews. Drug discovery

    2023  Volume 22, Issue 10, Page(s) 769–770

    MeSH term(s) Child ; Humans ; Medical Oncology ; Neoplasms/drug therapy ; Drug Development
    Language English
    Publishing date 2023-09-08
    Publishing country England
    Document type News ; Research Support, Non-U.S. Gov't
    ZDB-ID 2062954-0
    ISSN 1474-1784 ; 1474-1776
    ISSN (online) 1474-1784
    ISSN 1474-1776
    DOI 10.1038/d41573-023-00136-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5564: Show issues Location:
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  4. Article ; Online: The evolution of clinical trials: Can we address the challenges of the future?

    Eichler, Hans-Georg / Sweeney, Fergus

    Clinical trials (London, England)

    2018  Volume 15, Issue 1_suppl, Page(s) 27–32

    Abstract: The authors describe key challenges facing the clinical trials community and propose solutions to these issues, including the role the Clinical Trials Transformation Initiative can play in addressing these issues. Specifically, the authors reflect on ... ...

    Abstract The authors describe key challenges facing the clinical trials community and propose solutions to these issues, including the role the Clinical Trials Transformation Initiative can play in addressing these issues. Specifically, the authors reflect on clinical trial globalization and the harmonization of frameworks and requirements across regions; the challenges associated with balancing the desire for external validity, pragmatic trials, and precision medicine; clinical trial transparency; and operational complexity and the expense of clinical trials. By addressing these challenges, future clinical trials will be more feasible, relevant, and credible, and support both the continuing altruistic contributions of patients and the collection of more meaningful data.
    MeSH term(s) Cooperative Behavior ; Humans ; Information Dissemination ; Precision Medicine/trends ; Quality Improvement/trends ; Randomized Controlled Trials as Topic/standards ; United States ; United States Food and Drug Administration
    Language English
    Publishing date 2018-02-21
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774518755058
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Added therapeutic benefit and drug licensing.

    Eichler, Hans-Georg / Enzmann, Harald / Rasi, Guido

    Nature reviews. Drug discovery

    2019  Volume 18, Issue 9, Page(s) 651–652

    MeSH term(s) Cost-Benefit Analysis/standards ; Drug Development/economics ; Drug Development/methods ; Humans ; Licensure ; Pharmaceutical Preparations/economics
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2019-08-22
    Publishing country England
    Document type News
    ZDB-ID 2062954-0
    ISSN 1474-1784 ; 1474-1776
    ISSN (online) 1474-1784
    ISSN 1474-1776
    DOI 10.1038/d41573-019-00068-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance.

    Jaksa, Ashley / Wu, James / Jónsson, Páll / Eichler, Hans-Georg / Vititoe, Sarah / Gatto, Nicolle M

    Journal of comparative effectiveness research

    2021  Volume 10, Issue 9, Page(s) 711–731

    Abstract: Decision-makers have become increasingly interested in incorporating real-world evidence (RWE) into their decision-making process. Due to concerns regarding the reliability and quality of RWE, stakeholders have issued numerous recommendation documents to ...

    Abstract Decision-makers have become increasingly interested in incorporating real-world evidence (RWE) into their decision-making process. Due to concerns regarding the reliability and quality of RWE, stakeholders have issued numerous recommendation documents to assist in setting RWE standards. The fragmented nature of these documents poses a challenge to researchers and decision-makers looking for guidance on what is 'high-quality' RWE and how it can be used in decision-making. We offer researchers and decision-makers a structure to organize the landscape of RWE recommendations and identify consensus and gaps in the current recommendations. To provide researchers with a much needed pathway for generating RWE, we discuss how decision-makers can move from fragmented recommendations to comprehensive guidance.
    MeSH term(s) Decision Making ; Evidence-Based Medicine ; Humans ; Reproducibility of Results
    Language English
    Publishing date 2021-04-30
    Publishing country England
    Document type Journal Article
    ISSN 2042-6313
    ISSN (online) 2042-6313
    DOI 10.2217/cer-2020-0228
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Increasing the impact of Post Authorisation Safety Studies: transparency is key.

    Kurz, Xavier / Arlett, Peter / Eichler, Hans-Georg / Nolte, Alexis / Straus, Sabine / Rasi, Guido

    European journal of internal medicine

    2020  Volume 83, Page(s) 6–7

    MeSH term(s) Europe ; Humans ; Pyridines ; Thiazoles
    Chemical Substances Pyridines ; Thiazoles ; edoxaban (NDU3J18APO)
    Language English
    Publishing date 2020-12-01
    Publishing country Netherlands
    Document type Journal Article ; Comment
    ZDB-ID 1038679-8
    ISSN 1879-0828 ; 0953-6205
    ISSN (online) 1879-0828
    ISSN 0953-6205
    DOI 10.1016/j.ejim.2020.11.019
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Patients, payers and developers of Orphan Medicinal Products: lessons learned from 10 years' multi-stakeholder dialogue on improving access in Europe via MoCA.

    Cavaller-Bellaubi, Maria / Hughes-Wilson, Wills / Kubinová, Šárka / Van de Casteele, Marc / Van Lente, Evert Jan / Degortes, Emanuele / Pontén, Johan / Eichler, Hans-Georg / Le Cam, Yann / Boselli, Simone / Bucsics, Anna

    Orphanet journal of rare diseases

    2023  Volume 18, Issue 1, Page(s) 144

    Abstract: Background: The Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) was established in 2013 with the intention of developing a coordinated mechanism between volunteering EU stakeholders and developers of Orphan Medicinal Products (OMPs) ... ...

    Abstract Background: The Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) was established in 2013 with the intention of developing a coordinated mechanism between volunteering EU stakeholders and developers of Orphan Medicinal Products (OMPs) to support the exchange of information aimed at enabling informed decisions on pricing and reimbursement at Member State level and to evaluate the value of an OMP based on a Transparent Value Framework. The objective of the collaborative approach was to support more equitable access to authorised therapies for people living with rare diseases, rational prices for payers and more predictable market conditions for OMP developers. Over the past 10 years, the MoCA has conducted a series of pilot projects, examining a variety of different products and technologies at different stages of development; and with contributions from a variety of patient representatives, participation from EU payers from a range of Member States and, recently, with EUnetHTA members and the European Medicines Agency participating in the meetings as observers.
    Results: 10 years on from the establishment of the MoCA, the European landscape has significantly evolved, not only in the field of drug development with increasingly transformative therapies based on novel technologies, but also in terms of larger numbers of approved treatments, increased budget impact and the resulting associated uncertainties; as well as in terms of stakeholder collaboration and interactions. The value of early dialogue with OMP developers, including the EU payer community via their national decision-making authorities, is a key element within this early interaction and contributes to identifying, managing and reducing uncertainties allowing a prospectively planned approach earlier in development and, consequently, to support more timely, sustainable and equitable access to new OMPs, particularly where there is a high unmet medical need.
    Conclusions: The voluntary, informal nature of the MoCA interactions creates a flexible framework for non-binding dialogue. A forum for such interactions is needed to achieve the aims of the MoCA and both to support healthcare systems in planning as well as to underpin timely, equitable and sustainable access to new therapies for patients with rare diseases within the EU.
    MeSH term(s) Humans ; Rare Diseases ; Europe ; Budgets ; Drug Development
    Language English
    Publishing date 2023-06-12
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2225857-7
    ISSN 1750-1172 ; 1750-1172
    ISSN (online) 1750-1172
    ISSN 1750-1172
    DOI 10.1186/s13023-023-02774-7
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  9. Book: Klinische Pharmakologie

    Eichler, Hans-Georg / Wolzt, Michael

    1992  

    Author's details von Hans-Georg Eichler und Michael Wolzt
    Keywords Clinical Trials ; Pharmacokinetics ; Klinische Prüfung ; Pharmakokinetik
    Subject Klinische Pharmakokinetik ; Toxikokinetik ; Arzneimittel ; Arzneimittelstudie
    Language German
    Size 80 S. : Ill., graph. Darst.
    Publisher Maudrich
    Publishing place Wien u.a.
    Publishing country Austria
    Document type Book
    Note Enth.: Planung und Durchführung von klinischen Studien. Angewandte Pharmakokinetik
    HBZ-ID HT005024129
    ISBN 3-85175-587-1 ; 978-3-85175-587-9
    Database Catalogue ZB MED Medicine, Health

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    Shelf markLoan statusLocation
    1993 A 3565 order for loan Magazin

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  10. Article ; Online: Towards a prevention model of health care.

    Breckenridge, Alasdair / Eichler, Hans-Georg

    Nature reviews. Drug discovery

    2013  Volume 12, Issue 8, Page(s) 563–564

    MeSH term(s) Health Care Costs ; Models, Theoretical ; Preventive Health Services/economics ; Preventive Health Services/organization & administration ; Primary Health Care/economics ; Primary Health Care/organization & administration
    Language English
    Publishing date 2013-08-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 2062954-0
    ISSN 1474-1784 ; 1474-1776
    ISSN (online) 1474-1784
    ISSN 1474-1776
    DOI 10.1038/nrd4077
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