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Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective.

Amos J de Jong1, Tessa I van Rijssel2, Mira G P Zuidgeest2

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Decentralized clinical trials (DCTs) offer better patient access and real-world data. European regulators see potential but raise concerns about oversight and safety, suggesting hybrid models for future research.

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Area of Science:

  • Clinical trial methodology
  • Regulatory science
  • Health services research

Background:

  • Decentralized clinical trials (DCTs) aim to enhance trial accessibility, diversity, and retention by shifting activities to participants' homes.
  • Traditional clinical trials face challenges in patient recruitment and real-world data representation.

Purpose of the Study:

  • To identify regulatory challenges and opportunities for implementing DCTs in the European Union.
  • To gather insights from European regulators on the future of decentralized and hybrid trial models.

Main Methods:

  • Conducted semi-structured interviews with 20 European regulators.
  • Qualitative analysis of regulatory perspectives on DCT implementation.

Main Results:

  • Regulators identified opportunities: reduced participant burden and more representative real-world data.
  • Key challenges include concerns about investigator oversight and participant safety with limited physical contact.
  • Hybrid clinical trial models combining on-site and decentralized elements were proposed.

Conclusions:

  • DCTs present significant opportunities for improving clinical trial conduct and patient engagement.
  • Addressing regulatory concerns regarding oversight and safety is crucial for widespread DCT adoption.
  • Hybrid trial designs may offer a balanced approach to leveraging DCT benefits while mitigating risks.