Mapping Challenges for Conducting Decentralized Clinical Trials in Denmark.

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:

• 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.