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  1. Representation and Extrapolation
    Evidence from Clinical Trials
    Author: Alsan, Marcella; Durvasula, Maya; Gupta, Harsh; Schwartzstein, Joshua; Williams, Heidi
    Published: October 2022
    Publisher:  National Bureau of Economic Research, Cambridge, Mass

    This article examines the consequences and causes of low enrollment of Black patients in clinical trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is more relevant for decision-making by physicians and... more

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    Sächsische Landesbibliothek - Staats- und Universitätsbibliothek Dresden
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    Universitätsbibliothek Freiburg
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    Helmut-Schmidt-Universität, Universität der Bundeswehr Hamburg, Universitätsbibliothek
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    Staats- und Universitätsbibliothek Hamburg Carl von Ossietzky
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    Technische Informationsbibliothek (TIB) / Leibniz-Informationszentrum Technik und Naturwissenschaften und Universitätsbibliothek
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    ZBW - Leibniz-Informationszentrum Wirtschaft, Standort Kiel
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    This article examines the consequences and causes of low enrollment of Black patients in clinical trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is more relevant for decision-making by physicians and patients when it is more representative of the group that is being treated. This generates the key result that the perceived benefit of a medicine for a group depends not only on the average benefit from a trial, but also on the share of patients from that group who were enrolled in the trial. In survey experiments, we find that physicians who care for Black patients are more willing to prescribe drugs tested in representative samples, an effect substantial enough to close observed gaps in the prescribing rates of new medicines. Black patients update more on drug efficacy when the sample that the drug is tested on is more representative, reducing Black-White patient gaps in beliefs about whether the drug will work as described. Despite these benefits of representative data, our framework predicts that those who have benefited more from past medical breakthroughs are less costly to enroll in the present, leading to persistence in who is represented in the evidence base

     
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    Source: Union catalogues
    Language: English
    Media type: Book
    Format: Online
    Series: NBER working paper series ; no. w30575
    Subjects: Arzneimittel; Pharmakologie; Schwarze Menschen; USA; Role and Effects of Psychological, Emotional, Social, and Cognitive Factors on Decision Making; National Government Expenditures and Related Policies; Health and Inequality
    Scope: 1 Online-Ressource, illustrations (black and white)
    Notes:

    Hardcopy version available to institutional subscribers
  2. The NBER Orange Book Dataset
    A User's Guide
    Author: Durvasula, Maya; Hemphill, C. Scott; Ouellette, Lisa Larrimore; Sampat, Bhaven N.; Williams, Heidi
    Published: November 2022
    Publisher:  National Bureau of Economic Research, Cambridge, Mass

    This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"--a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable... more

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    Verlag (kostenfrei)
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    Sächsische Landesbibliothek - Staats- und Universitätsbibliothek Dresden
    Inter-library loan:
    No inter-library loan

    Location:
    Universitätsbibliothek Freiburg
    Inter-library loan:
    No inter-library loan

    Location:
    Helmut-Schmidt-Universität, Universität der Bundeswehr Hamburg, Universitätsbibliothek
    Inter-library loan:
    No inter-library loan

    Location:
    Staats- und Universitätsbibliothek Hamburg Carl von Ossietzky
    Inter-library loan:
    No inter-library loan

    Location:
    Technische Informationsbibliothek (TIB) / Leibniz-Informationszentrum Technik und Naturwissenschaften und Universitätsbibliothek
    Inter-library loan:
    No inter-library loan

    Location:
    ZBW - Leibniz-Informationszentrum Wirtschaft, Standort Kiel
    Inter-library loan:
    No inter-library loan

     

    This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"--a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry. We summarize the Orange Book's coverage and discuss the opportunities and challenges associated with using these data for research. Empirical validations against various administrative datasets suggest that Orange Book records are, largely, complete and accurate. We conclude with a specific use case--calculating legal exclusivity periods for drugs--to highlight the types of choices that researchers must make when using this resource

     
    Export to reference management software   RIS file
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    Source: Union catalogues
    Language: English
    Media type: Book
    Format: Online
    Series: NBER working paper series ; no. w30628
    Subjects: Arzneimittel; Innovation; Pharmakologie; Pharmaindustrie; Patent; USA; General; Innovation; Research and Development; Technological Change; Intellectual Property Rights
    Scope: 1 Online-Ressource, illustrations (black and white)
    Notes:

    Hardcopy version available to institutional subscribers