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A new Frontiers Research Topic is now open! It is dedicated to Real World Data (RWD) generated for regulatory purposes in the rare diseases setting.

Viviana Giannuzzi from Fondazione Benzi is the co-editor of this Research Topic!

RWD may be related with health-related data not collected within the context of a typical clinical research setting, such as randomised controlled trials. Over the last years, the use of RWD for health purposes has been increasing rapidly. Such a use could complement traditional health care data sources to provide broader insights into in a real-world setting. RWD has the potential to be used as a source of Real World Evidence (RWE) that can be a useful source of information also for regulatory purposes, in both marketing authorisation and post marketing authorisation phases.

RWD is also of interest in the field or rare diseases as the scarcity of individuals living with a particular condition as well as the heterogeneity of the disease are just some of the challenges making the traditional clinical research difficult and lengthy.

Experts such as scientists, economists and experts in social sciences are invited to propose their original research articles, reviews and meta-analyses describing the use of RWD in the orphan medicines Research & Development (R&D) and picture the possible economic, social and political impact.

Key themes within this Research Topic are:

  • Facilitation by national authorities of RWD use
  • Use of RWE by Health Technology Assessment bodies and payers to support decisions on cost-effectiveness
  • Research activities specifically aimed to implement RWD in the orphan medicines R&D for regulatory purposes
  • Impact of off-label prescription data for regulatory purposes e.g., for repurposing
  • Economic, political and social implications of the collection and use of RWD
  • Use of analytic tools and methodologies such as Artificial Intelligence
  • Post-marketing data collection based on RWD

Submit your abstract by 5 February 2022 and the manuscript by 6 April 2022 here!

Discover more about the Research Topic by visiting the Frontiers website where you can also find the author guidelines.

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