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Cloud computing offers benefits and risks for clinical trials. The European Clinical Research Infrastructures Network (ECRIN) workshop highlighted the need for guidance and a European community cloud for trial data.

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Area of Science:

  • Clinical research informatics
  • Health data management
  • Cloud computing applications

Background:

  • Increasing adoption of cloud computing in clinical trials necessitates risk assessment.
  • The European Clinical Research Infrastructures Network (ECRIN) organized a workshop to address cloud computing in multinational clinical research.
  • Current challenges include understanding cloud services, associated risks, and the lack of specific regulatory guidance.

Framework:

  • Discussion focused on the nature of cloud computing and the industry landscape.
  • Key risks associated with current cloud service utilization were identified.
  • The absence of explicit guidance for cloud computing in clinical trials was a significant concern.

Implementation:

  • Exploration of potential risk mitigation strategies for cloud adoption.
  • Significant interest was shown in developing a European 'community cloud' for academic clinical trial data.
  • The workshop was recognized as an initial step in an ongoing dialogue.

Implications:

  • Further discussions are required to clarify trial-specific regulatory requirements for cloud computing.
  • Involving regulatory bodies in future discussions is crucial for developing clear guidelines.
  • Establishing a secure, European-focused cloud infrastructure could enhance multinational clinical research data management.