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  1. Article ; Online: Alternatives to Intention-to-Treat Analyses-Reply.

    DeMets, David L / Cook, Thomas D

    JAMA

    2019  Volume 321, Issue 21, Page(s) 2135

    MeSH term(s) Intention to Treat Analysis
    Language English
    Publishing date 2019-06-04
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2019.3096
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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  2. Book: Fundamentals of clinical trials

    Friedman, Lawrence M. / Furberg, Curt / DeMets, David L. / Reboussin, David M. / Granger, Christopher B.

    2015  

    Author's details Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Keywords Clinical Trials as Topic ; Research Design ; Klinische Prüfung
    Subject Arzneimittel ; Arzneimittelstudie
    Language English
    Size xxi, 550 Seiten, Diagramme
    Edition Fifth edition
    Publisher Springer
    Publishing place Cham
    Publishing country Switzerland
    Document type Book
    HBZ-ID HT019054042
    ISBN 978-3-319-307732 ; 9783319185392 ; 3-319-30773-8 ; 331918539X
    Database Catalogue ZB MED Medicine, Health

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    Shelf markLoan statusLocation
    2016 A 1857 available for loan (reading room) Lesesaal EG

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  3. Article ; Online: Training the Next Generation of Data Monitoring Committee Members: An Initiative of the Heart Failure Collaboratory.

    Fleming, Thomas R / Wittes, Janet / Fiuzat, Mona / Bristow, Michael R / Rockhold, Frank W / Connor, Jason T / Saville, Benjamin R / Claggett, Brian / Cavagna, Isabella / Abraham, William T / Cook, Thomas D / Lindenfeld, JoAnn / O'Connor, Christopher / DeMets, David L

    JACC. Heart failure

    2024  

    Abstract: Clinical trials are vital for assessing therapeutic interventions. The associated data monitoring committees (DMCs) safeguard patient interests and enhance trial integrity, thus promoting timely, reliable evaluations of those interventions. We face an ... ...

    Abstract Clinical trials are vital for assessing therapeutic interventions. The associated data monitoring committees (DMCs) safeguard patient interests and enhance trial integrity, thus promoting timely, reliable evaluations of those interventions. We face an urgent need to recruit and train new DMC members. The Heart Failure Collaboratory (HFC), a multidisciplinary public-private consortium of academics, trialists, patients, industry representatives, and government agencies, is working to improve the clinical trial ecosystem. The HFC aims to improve clinical trial efficiency and quality by standardizing concepts, and to help meet the demand for experienced individuals on DMCs by creating a standardized approach to training new members. This paper discusses the HFC's training workshop, and an apprenticeship model for new DMC members. It describes opportunities and challenges DMCs face, along with common myths and best practices learned through previous experiences, with an emphasis on data confidentiality and need for quality independent statistical reporting groups.
    Language English
    Publishing date 2024-03-23
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2705621-1
    ISSN 2213-1787 ; 2213-1779
    ISSN (online) 2213-1787
    ISSN 2213-1779
    DOI 10.1016/j.jchf.2024.02.016
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  4. Book: Fundamentals of clinical trials

    Friedman, Lawrence M. / Furberg, Curt / DeMets, David L.

    2010  

    Author's details Lawrence M. Friedman ; Curt D. Furberg ; David L. DeMets
    Keywords Clinical Trials as Topic ; Research Design
    Language English
    Size XVIII, 445 S. : graph. Darst.
    Edition 4. ed.
    Publisher Springer
    Publishing place New York u.a.
    Publishing country United States
    Document type Book
    Note Literaturangaben
    HBZ-ID HT016556592
    ISBN 978-1-4419-1585-6 ; 9781441915863 ; 1-4419-1585-0 ; 1441915869
    Database Catalogue ZB MED Medicine, Health

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    Shelf markLoan statusLocation
    2010 A 5237 order for loan Magazin

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  5. Article ; Online: Genomic surveillance to combat COVID-19: challenges and opportunities.

    Robishaw, Janet D / Alter, Scott M / Solano, Joshua J / Shih, Richard D / DeMets, David L / Maki, Dennis G / Hennekens, Charles H

    The Lancet. Microbe

    2021  Volume 2, Issue 9, Page(s) e481–e484

    Abstract: Although the development and increasingly widespread availability of effective and safe vaccines provides the greatest hope for the future recovery from the increasingly devastating COVID-19 pandemic, there are other preventive efforts that offer an ... ...

    Abstract Although the development and increasingly widespread availability of effective and safe vaccines provides the greatest hope for the future recovery from the increasingly devastating COVID-19 pandemic, there are other preventive efforts that offer an immediate route to decreasing morbidity and mortality. Genomic surveillance is emerging as a vital necessity to achieve effective mitigation and containment. Since SARS-CoV-2 variants have already been detected, it is crucial to obtain reliable evidence about whether they are more contagious, virulent, or more resistant to the available COVID-19 vaccines well before they spread throughout the world. Genomic surveillance leverages applications of next-generation sequencing, creates the availability of whole genome data, and advances phylogenetic methods. These methods offer novel means to detect variants that are phenotypically or antigenically different. Genomic surveillance will facilitate greater early anticipation as well as initiation of effective strategies to mitigate and contain outbreaks of SARS-CoV-2 variants and other novel viruses.
    MeSH term(s) COVID-19/epidemiology ; COVID-19 Vaccines/therapeutic use ; Genomics ; Humans ; Pandemics/prevention & control ; Phylogeny ; SARS-CoV-2/genetics
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2021-07-27
    Publishing country England
    Document type Journal Article ; Review
    ISSN 2666-5247
    ISSN (online) 2666-5247
    DOI 10.1016/S2666-5247(21)00121-X
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  6. Article ; Online: COVID-19 control in the United States: the case for masking.

    Maki, Dennis G / Alter, Scott M / Solano, Joshua J / Adirim, Terry A / DeMets, David L / Shih, Richard D / Hennekens, Charles H

    The American journal of managed care

    2021  Volume 27, Issue 7, Page(s) e218–e220

    Abstract: As of May 2021, the United States remains the world leader with 33 million of 165 million cases worldwide (20%) and 590,000 of 3.4 million deaths worldwide (17%) from COVID-19. Achieving herd immunity by disease spread and vaccination may result in 2 ... ...

    Abstract As of May 2021, the United States remains the world leader with 33 million of 165 million cases worldwide (20%) and 590,000 of 3.4 million deaths worldwide (17%) from COVID-19. Achieving herd immunity by disease spread and vaccination may result in 2 million to 4 million total US deaths. The future perfect of the vaccine should not be the enemy of the present good, which is masking. Masking, especially when combined with social distancing, crowd avoidance, frequent hand and face washing, increased testing capabilities, and contact tracing, is likely to prevent at least as many premature deaths as the widespread utilization of an effective and safe vaccine. Worldwide, masking is the oldest and simplest engineered control to prevent transmission of respiratory pathogens. Masking has been a cornerstone of infection control in hospitals, operating rooms, and clinics for more than a century. Unfortunately, since the epidemic began in the United States, masking has become politicized. All countries, but especially the United States, must adopt masking as an urgent necessity and a component of coordinated public health strategies to combat the COVID-19 pandemic. Any economic advantages of pandemic politics are short-lived and shortsighted in comparison with public health strategies of proven benefit that can prevent needless and mostly avoidable premature deaths from COVID-19. During the worst epidemic in more than 100 years, most Americans (75%) trust their health care providers. As competent and compassionate health care professionals, we recommend that effective strategies, especially masking, and not pandemic politics, should inform all rational clinical and public health decision-making.
    MeSH term(s) COVID-19/epidemiology ; COVID-19/prevention & control ; Contact Tracing/statistics & numerical data ; Humans ; Infection Control/statistics & numerical data ; Masks/statistics & numerical data ; Physical Distancing ; United States
    Language English
    Publishing date 2021-07-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2035781-3
    ISSN 1936-2692 ; 1088-0224 ; 1096-1860
    ISSN (online) 1936-2692
    ISSN 1088-0224 ; 1096-1860
    DOI 10.37765/ajmc.2021.88670
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  7. Article ; Online: Guidelines for Statistical Analysis Plans.

    DeMets, David L / Cook, Thomas D / Buhr, Kevin A

    JAMA

    2017  Volume 318, Issue 23, Page(s) 2301–2303

    Language English
    Publishing date 2017--19
    Publishing country United States
    Document type Editorial ; Comment
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2017.18954
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  8. Article ; Online: Establishing and Maintaining Research Integrity at Academic Institutions: Challenges and Opportunities.

    Robishaw, Janet D / DeMets, David L / Wood, Sarah K / Boiselle, Phillip M / Hennekens, Charles H

    The American journal of medicine

    2019  Volume 133, Issue 3, Page(s) e87–e90

    Abstract: Integrity and trust are essential attributes of medical researchers. Research misconduct represents clear and present dangers to academic institutions and their faculty, residents, students, and staff. To achieve and maintain public trust, medical ... ...

    Abstract Integrity and trust are essential attributes of medical researchers. Research misconduct represents clear and present dangers to academic institutions and their faculty, residents, students, and staff. To achieve and maintain public trust, medical researchers must achieve and maintain research integrity. To do so requires synchronicity and collaboration between and within academic institutions. Substantial failures to maintain research integrity by institutional leadership will lead to increasing demands to do so from the funding organizations and the general public. This, in turn, will lead to avoidable consequences of substantial penalties, financial and otherwise, adverse publicity, and reputational damage. Researchers must self-regulate to avoid pitfalls, including those created by changes in the medical care delivery system that have decreased the influence of health care providers and increased the influence of outside legal and business interests. Our common goal should be to return public trust in our research enterprise that has done so much good for so many, but requires the establishment and maintenance of vigilance to establish and maintain research integrity.
    MeSH term(s) Ethics, Research ; Universities/ethics
    Language English
    Publishing date 2019-09-12
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 80015-6
    ISSN 1555-7162 ; 1873-2178 ; 0002-9343 ; 1548-2766
    ISSN (online) 1555-7162 ; 1873-2178
    ISSN 0002-9343 ; 1548-2766
    DOI 10.1016/j.amjmed.2019.08.036
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    Ua VI Zs.289: Show issues Location:
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  9. Article ; Online: Ivermectin in COVID-19: The Case for a Moratorium on Prescriptions.

    Molnar, Andreea / Lau, Stephanie / Berges, Maja / Masa, Raymond B / Solano, Joshua J / Alter, Scott M / Clayton, Lisa M / Shih, Richard D / DeMets, David L / Maki, Dennis G / Hennekens, Charles H

    Therapeutic innovation & regulatory science

    2022  Volume 56, Issue 3, Page(s) 382–385

    Abstract: In treatment or prevention of COVID-19, ivermectin is not approved by the United States (US) Food and Drug Administration (FDA). Nonetheless, in the US, prescriptions of ivermectin by healthcare providers have increased > tenfold from 3589 per week pre- ... ...

    Abstract In treatment or prevention of COVID-19, ivermectin is not approved by the United States (US) Food and Drug Administration (FDA). Nonetheless, in the US, prescriptions of ivermectin by healthcare providers have increased > tenfold from 3589 per week pre-COVID-19 to 39,102. Ivermectin is FDA approved for animals to treat parasites and for humans to treat intestinal strongyloidiasis and onchocerciasis orally, and ectoparasites and skin conditions topically. It is not a benign drug, with reported side effects including cutaneous, gastrointestinal, and cardiovascular symptoms. The evidence to support ivermectin to treat or prevent COVID-19 includes some basic research and inconsistent clinical observations that contribute to the formulation of a hypothesis of efficacy in COVID-19. At present, data from peer-reviewed published randomized trials of sufficient size, dose, and duration to reliably test the hypothesis of the most plausible small to moderate benefits on clinically relevant endpoints are sparse. In addition to the US FDA, the US National Institutes of Health, World Health Organization, and European Medicines Agency have all advised against ivermectin for treatment or prevention of COVID-19 outside of randomized trials. For ivermectin in treatment or prevention of COVID-19, healthcare providers should reassure all patients that if sufficient evidence were to emerge, then this drug could be considered a therapeutic innovation and regulatory authorities would approve the drug. In the meanwhile, we strongly recommend a moratorium on the prescription of ivermectin for the treatment or prevention of COVID-19 except in randomized trials to provide the most reliable test of the hypothesis.
    MeSH term(s) Animals ; Humans ; Ivermectin/adverse effects ; Ivermectin/therapeutic use ; Prescriptions ; SARS-CoV-2 ; COVID-19 Drug Treatment
    Chemical Substances Ivermectin (70288-86-7)
    Language English
    Publishing date 2022-02-11
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2708397-4
    ISSN 2168-4804 ; 2168-4790
    ISSN (online) 2168-4804
    ISSN 2168-4790
    DOI 10.1007/s43441-022-00378-0
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  10. Article ; Online: Updates on Hydroxychloroquine in Prevention and Treatment of COVID-19.

    Hennekens, Charles H / Rane, Manas / Solano, Joshua / Alter, Scott / Johnson, Heather / Krishnaswamy, Shiv / Shih, Richard / Maki, Dennis / DeMets, David L

    The American journal of medicine

    2021  Volume 135, Issue 1, Page(s) 7–9

    MeSH term(s) Antimalarials/administration & dosage ; Antimalarials/adverse effects ; Arrhythmias, Cardiac/chemically induced ; Arrhythmias, Cardiac/epidemiology ; Arrhythmias, Cardiac/prevention & control ; COVID-19/epidemiology ; COVID-19/prevention & control ; Chemoprevention/adverse effects ; Chemoprevention/methods ; Humans ; Hydroxychloroquine/administration & dosage ; Hydroxychloroquine/adverse effects ; Randomized Controlled Trials as Topic ; Risk Assessment ; SARS-CoV-2 ; COVID-19 Drug Treatment
    Chemical Substances Antimalarials ; Hydroxychloroquine (4QWG6N8QKH)
    Language English
    Publishing date 2021-08-23
    Publishing country United States
    Document type Editorial
    ZDB-ID 80015-6
    ISSN 1555-7162 ; 1873-2178 ; 0002-9343 ; 1548-2766
    ISSN (online) 1555-7162 ; 1873-2178
    ISSN 0002-9343 ; 1548-2766
    DOI 10.1016/j.amjmed.2021.07.035
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