Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance

  • Ashley Jaksa
    Scientific Research, Aetion Inc., 5 Penn Plaza, 7th Fl., New York, NY 10001, USA
  • James Wu
    Amgen Inc, 1 Amgen Center Drive, Thousand Oaks, CA 91320-1779, USA
  • Páll Jónsson
    National Institute for Health & Care Excellence, Level 1A, City Tower, Piccadilly Plaza Manchester, M1 4BT, UK
  • Hans-Georg Eichler
    European Medicines Agency, Domenico Scarlattilaan 6, Amsterdam 1083 HS, Netherlands
  • Sarah Vititoe
    Scientific Research, Aetion Inc., 5 Penn Plaza, 7th Fl., New York, NY 10001, USA
  • Nicolle M Gatto
    Scientific Research, Aetion Inc., 5 Penn Plaza, 7th Fl., New York, NY 10001, USA

説明

<jats:p>Decision-makers have become increasingly interested in incorporating real-world evidence (RWE) into their decision-making process. Due to concerns regarding the reliability and quality of RWE, stakeholders have issued numerous recommendation documents to assist in setting RWE standards. The fragmented nature of these documents poses a challenge to researchers and decision-makers looking for guidance on what is ‘high-quality’ RWE and how it can be used in decision-making. We offer researchers and decision-makers a structure to organize the landscape of RWE recommendations and identify consensus and gaps in the current recommendations. To provide researchers with a much needed pathway for generating RWE, we discuss how decision-makers can move from fragmented recommendations to comprehensive guidance.</jats:p>

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