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Area of Science:

  • Digital Health Technologies
  • Regulatory Science
  • Clinical Trial Endpoints

Background:

  • The increasing use of digital measures and digitally derived endpoints in drug development necessitates globally harmonized approaches.
  • Acceptance by regulatory authorities and health technology assessment (HTA) bodies is vital for decision-making.
  • A common language and aligned concepts are essential for maximizing the value of digital measures in global drug development.

Purpose of the Study:

  • To review challenges in advancing digital endpoints within the pharmaceutical industry.
  • To highlight the need for a common lexicon to address inconsistent terminology and definitions.
  • To advocate for standardization to improve regulatory and payer harmonization and acceptance.

Main Methods:

  • Review of current challenges and terminology in the field of digital endpoints by the EFPIA digital endpoint joint subgroup.
  • Analysis of inconsistencies in terms like 'monitoring', 'electronic' vs. 'digital', and 'raw' data.

Main Results:

  • Significant confusion exists due to varied terminology and definitions for digital health technologies and derived data.
  • Different regulatory agencies interpret common terms like 'monitoring' differently.
  • The use of 'e' for electronic versus 'digital' creates ambiguity.

Conclusions:

  • An aligned lexicon is urgently needed to standardize the development, validation, and use of digital endpoints.
  • Standardization will foster consistency in this rapidly evolving research area.
  • Harmonization and acceptance by regulatory bodies and payers will be enhanced through a common language.