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Mapping Challenges for Conducting Decentralized Clinical Trials in Denmark.

Ditte Weber1, Michelle Birknow2, Louise Hansen3

  • 1Department of Sustainability and Planning, Aalborg University.

Studies in Health Technology and Informatics
|May 13, 2025
PubMed
Summary
This summary is machine-generated.

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Decentralized Clinical Trials (DCTs) in Denmark face challenges in defining activities, recruitment, data management, and participant safety oversight. Addressing these requires collaboration and standardized approaches for successful implementation.

Area of Science:

  • Clinical research methodology
  • Health informatics
  • Regulatory science

Background:

  • Decentralized Clinical Trials (DCTs) offer potential benefits but present unique implementation challenges.
  • Stakeholder perspectives are crucial for understanding and overcoming barriers to DCT adoption.

Purpose of the Study:

  • To identify and analyze the challenges of conducting DCTs in Denmark from the perspective of key stakeholders.
  • To provide insights for optimizing DCT implementation in the Danish healthcare context.

Main Methods:

  • Qualitative analysis of stakeholder feedback on DCT implementation.
  • Identification of key challenge areas including operational, technical, and safety aspects.

Main Results:

Keywords:
Decentralized clinical trialsaccessibilityelectronic data capturepatient-centered healthcaretelehealth

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  • Challenges identified in defining and disseminating DCT activities and recruitment strategies.
  • Difficulties in remote data access, endpoint validation, IT system integration, and Investigational Medical Product (IMP) management.
  • Concerns regarding side effect reporting accuracy and principal investigator (PI) oversight of participant safety (TP).

Conclusions:

  • Successful DCT implementation in Denmark requires addressing challenges in operational execution, data management, and safety surveillance.
  • Establishment of national working groups indicates a proactive approach to tackling DCT-related issues.