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Latest Research and Reviews

  • Reviews |

    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
    • , Alasdair Breckenridge
    • , Bruno Flamion
    • , Lars L. Gustafsson
    • , Hubert Leufkens
    • , Malcolm Rowland
    • , Christian K. Schneider
    •  & Brigitte Bloechl-Daum
  • Reviews |

    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
    • , Eric Abadie
    • , David Barnett
    • , Franz König
    •  & Steven Pearson

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