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  1. Article ; Online: Monitoring Multiple U.S. Government-Supported Covid-19 Vaccine Trials.

    Hunsberger, Sally / Ellenberg, Susan S / Joffe, Steven / Babiker, Abdel / Fix, Alan / Griffin, Marie R / Kalil, Jorge / Levine, Myron M / Makgoba, Malegapuru W / Moore, Reneé H / Tsiatis, Anastasios A / Whitley, Richard

    NEJM evidence

    2023  Volume 2, Issue 3, Page(s) EVIDctcs2200301

    Abstract: Monitoring U.S. Government-Supported Covid-19 Vaccine TrialsOperation Warp Speed was a partnership ...

    Abstract Monitoring U.S. Government-Supported Covid-19 Vaccine TrialsOperation Warp Speed was a partnership created to accelerate the development of Covid-19 vaccines. The National Institutes of Health oversaw one data and safety monitoring board to review/monitor all Operation Warp Speed trials. This article describes the challenges faced in monitoring these trials and provides ideas for future similar endeavors.
    MeSH term(s) United States ; Humans ; COVID-19 Vaccines ; COVID-19 ; Clinical Trials Data Monitoring Committees ; National Institutes of Health (U.S.)
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2023-02-28
    Publishing country United States
    Document type Journal Article
    ISSN 2766-5526
    ISSN (online) 2766-5526
    DOI 10.1056/EVIDctcs2200301
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Commentary on 'How the debate about comparative effectiveness research (CER) should impact the future of clinical trials' by Michael S. Lauer.

    Ellenberg, Jonas H

    Statistics in medicine

    2012  Volume 31, Issue 25, Page(s) 3054–6; discussion 3066–7

    MeSH term(s) Comparative Effectiveness Research/organization & administration ; Randomized Controlled Trials as Topic/standards
    Language English
    Publishing date 2012-11-10
    Publishing country England
    Document type Comment ; Journal Article
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.5399
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  3. Article ; Online: Proceedings of the University of Pennsylvania 14th annual conference on statistical issues in clinical trials: Subgroup analysis in randomized clinical trials-Challenges and opportunities.

    Ellenberg, Susan S / Ellenberg, Jonas H

    Clinical trials (London, England)

    2023  Volume 20, Issue 4, Page(s) 325–327

    MeSH term(s) Humans ; Data Interpretation, Statistical ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2023-05-18
    Publishing country England
    Document type Congress
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/17407745231173007
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  4. Article ; Online: Proceedings of the University of Pennsylvania 13th annual conference on statistical issues in clinical trials: Cluster randomized clinical trials-Challenges and opportunities.

    Ellenberg, Susan S / Ellenberg, Jonas H

    Clinical trials (London, England)

    2022  Volume 19, Issue 4, Page(s) 351–352

    MeSH term(s) Congresses as Topic ; Data Interpretation, Statistical ; Humans ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2022-06-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/17407745221100226
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  5. Book ; Online ; E-Book: Data monitoring committees in clinical trials

    Ellenberg, Susan S. / Fleming, Thomas R. / DeMets, David L.

    a practical perspective

    (Statistics in practice)

    2019  

    Author's details Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets
    Series title Statistics in practice
    Keywords Clinical Trials Data Monitoring Committees / organization & administration ; Clinical Trials as Topic ; Data Collection / methods ; Clinical Trials Data Monitoring Committees / ethics
    Language English
    Size 1 Online-Ressource (xxii, 468 Seiten), Diagramme
    Edition Second edition
    Publisher Wiley
    Publishing place Hoboken, NJ
    Publishing country United States
    Document type Book ; Online ; E-Book
    Remark Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    HBZ-ID HT019972321
    ISBN 978-1-119-51264-6 ; 978-1-119-51267-7 ; 9781119512653 ; 1-119-51264-6 ; 1-119-51267-0 ; 1119512654
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  6. Article ; Online: Clinical trials in the time of a pandemic.

    Ellenberg, Susan S

    Clinical trials (London, England)

    2020  Volume 17, Issue 5, Page(s) 467–471

    Abstract: The first rumblings about a new coronavirus spreading in China were heard in January 2020. By the end of that month, the World Health Organization, recognizing the severity of the disease and the potential for global spread, had declared a public health ... ...

    Abstract The first rumblings about a new coronavirus spreading in China were heard in January 2020. By the end of that month, the World Health Organization, recognizing the severity of the disease and the potential for global spread, had declared a public health emergency. By February 2020, cases had been identified in multiple countries, clinical trials of treatments with some biological plausibility had begun in China, and the initial steps of vaccine development were underway. In mid-March, by which time countries around the world were experiencing rapidly increasing numbers of cases and deaths, the World Health Organization categorized the outbreak as a pandemic. This new coronavirus was designated SARS-COV-2 in recognition of its similarity to the coronavirus responsible for the severe acute respiratory syndrome outbreak in 2002-2003. The race is on to develop treatments that can mitigate the severe consequences of infection and vaccines that can prevent infection and/or diminish the severity of disease in those who do get infected. Many challenges face these development efforts. Some are similar to those faced in the past; others are new. The urgency of finding ways to treat, and ultimately prevent, the consequences of this new and potentially deadly infection has led to unprecedented focus on clinical trials.
    MeSH term(s) Betacoronavirus ; COVID-19 ; Clinical Trials as Topic/methods ; Coronavirus Infections/epidemiology ; Disease Transmission, Infectious/prevention & control ; Humans ; Pandemics/prevention & control ; Pneumonia, Viral/epidemiology ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-07-10
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774520939871
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Book ; Conference proceedings: Proceedings from the University of Pennsylvania 2009 Conference Statistical Issues in Clinical Trials: From Bench to Bedside to Community

    Ellenberg, Jonas H. / Ellenberg, Susan S.

    (Clinical trials ; 7,5)

    2010  

    Institution University of Pennsylvania
    Event/congress Conference on Statistical Issues in Clinical Trials: From Bench to Bedside to Community (2009, PhiladelphiaPa.)
    Author's details guest ed.: Jonas H. Ellenberg and Susan S. Ellenberg
    Series title Clinical trials ; 7,5
    Collection
    Language English
    Size S. 513 - 616 : graph. Darst.
    Publisher Sage
    Publishing place Los Angeles u.a.
    Publishing country United States
    Document type Book ; Conference proceedings
    HBZ-ID HT016557521
    Database Catalogue ZB MED Medicine, Health

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    In stock of ZB MED Cologne/Königswinter

    Shelf markLoan statusLocation
    Zs A 5831 -7- not available for loan Zeitschriften-Lesesaal

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  8. Article ; Online: Proceedings of the University of Pennsylvania 12th annual conference on statistical issues in clinical trials: Electronic health records (EHR) in randomized clinical trials-Challenges and opportunities.

    Ellenberg, Susan S / Ellenberg, Jonas H

    Clinical trials (London, England)

    2020  Volume 17, Issue 4, Page(s) 343–345

    MeSH term(s) Biometry ; Congresses as Topic ; Data Interpretation, Statistical ; Electronic Health Records ; Humans ; Pennsylvania ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/statistics & numerical data ; Research Design ; Statistics as Topic/methods ; Universities
    Language English
    Publishing date 2020-06-10
    Publishing country England
    Document type Editorial
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774520931112
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Early Termination of Clinical Trials for Futility - Considerations for a Data and Safety Monitoring Board.

    Ellenberg, Susan S / Shaw, Pamela A

    NEJM evidence

    2022  Volume 1, Issue 7, Page(s) EVIDctw2100020

    Abstract: Early Termination of Clinical Trials for FutilityClinical trials may be stopped for futility if there is little or no chance of demonstrating the hoped-for effect. Reasons include evidence of no treatment effect, substantial missing data that would ... ...

    Abstract Early Termination of Clinical Trials for FutilityClinical trials may be stopped for futility if there is little or no chance of demonstrating the hoped-for effect. Reasons include evidence of no treatment effect, substantial missing data that would unacceptably undermine trial conclusions, or event rates too low to support meaningful comparisons. This review examines issues faced by DSMBs in such settings.
    Language English
    Publishing date 2022-06-28
    Publishing country United States
    Document type Journal Article ; Review
    ISSN 2766-5526
    ISSN (online) 2766-5526
    DOI 10.1056/EVIDctw2100020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Rejoinder.

    Ellenberg, Susan S / Morris, Jeffrey S

    Statistics in medicine

    2021  Volume 40, Issue 11, Page(s) 2536–2539

    Language English
    Publishing date 2021-04-20
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Comment
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.8984
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