Innovation at the Intersection of Clinical Trials and Real-World Data Science to Advance Patient Care

Allbwn ymchwil: Cyfraniad at gyfnodolynErthygladolygiad gan gymheiriaid

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Dangosydd eitem ddigidol (DOI)

  • Brandon Swift
    Advanced Analytics, IQVIA
  • Lokesh Jain
    Quantitative Pharmacology and Pharmacometrics, Merck & Co, NJ
  • Craig White
    Harvard University
  • Vasu Chandrasekaran
    Center for Observational and Real World Evidence, Merck & Co, MA
  • Aman Bhandari
    Center for Observational and Real World Evidence, Merck & Co, MA
  • Dyfrig Hughes
  • Pravin Jadhav
    Otsuka Pharmaceutical Development and Commercialization (OPDC), Princeton, NJ
While efficacy and safety data collected from randomized clinical trials are the
evidentiary standard for determining market authorization, this alone may no longer be sufficient to address the needs of key stakeholders (regulators, providers and payers) and guarantee long-term success of pharmaceutical products. There is a heightened interest from stakeholders on understanding the use of real-world evidence (RWE) to substantiate benefit-risk assessment and support the value of a new drug. This review provides an overview of real-world data (RWD) and related advances in the regulatory framework,
and discusses their impact on clinical research and development. A framework for linking drug development decisions with the value proposition of the drug, utilizing pharmacokinetic-pharmacodynamic-pharmacoeconomic (PK-PD-PE) models, is introduced. The summary presented here is based on the presentations and discussion at the symposium entitled Innovation at the Intersection of Clinical Trials and Real-World Data to Advance Patient Care at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2017 annual conference.
Iaith wreiddiolSaesneg
Tudalennau (o-i)450-460
Nifer y tudalennau11
CyfnodolynClinical and Translational Science
Cyfrol11
Rhif y cyfnodolyn5
Dyddiad ar-lein cynnar16 Mai 2018
Dynodwyr Gwrthrych Digidol (DOIs)
StatwsCyhoeddwyd - Medi 2018

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