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Showing 1–3 of 3 results
Advanced filters: Author: Brigitte Bloechl-Daum Clear advanced filters

  • Regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, Eichler and colleagues discuss the consequences of regulatory risk-aversion and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.

    • Hans-Georg Eichler
    • Brigitte Bloechl-Daum
    • Guido Rasi
    Reviews
    Nature Reviews Drug Discovery
    Volume: 12, P: 907-916

  • Third-party payers typically base their reimbursement decisions for a new drug predominantly on its health benefits relative to existing treatment options — termed relative efficacy (RE). Over the past decade, the role of payers has become more prominent, and drug developers increasingly need to satisfy the sometimes divergent needs of both regulators and payers to achieve market success. This article describes the political background to the RE debate and the challenges of RE assessment, and discusses the impact of RE on drug development.

    • Hans-Georg Eichler
    • Brigitte Bloechl-Daum
    • Steven Pearson
    Reviews
    Nature Reviews Drug Discovery
    Volume: 9, P: 277-291

  • The efficacy–effectiveness gap describes the difference in drug performance under clinical trial conditions versus real-life conditions. Here, the authors argue that this phenomenon is due to variability in drug responses. They discuss the underlying biological and behavioural reasons for this phenomenon and propose strategies to 'bridge the gap'.

    • Hans-Georg Eichler
    • Eric Abadie
    • Brigitte Bloechl-Daum
    Reviews
    Nature Reviews Drug Discovery
    Volume: 10, P: 495-506