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Six solutions for clinical study data sharing in Germany.

Evgeny Bobrov1, Christina Habermehl2,3,4, Daniel Strech2

  • 1QUEST Center for Responsible Research, Berlin Institute of Health at Charité- Universitätsmedizin Berlin, Berlin, Germany. evgeny.bobrov@bih-charite.de.

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Summary
This summary is machine-generated.

Clinical study data sharing in Germany faces significant obstacles, leading to low rates and wasted resources. This opinion piece proposes six actionable steps to improve data availability and overcome these barriers.

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Area of Science:

  • Health Research
  • Clinical Data Management
  • Data Sharing Policies

Background:

  • Sharing clinical study data is widely endorsed but remains an exception in practice.
  • Low data sharing rates in Germany hinder research progress and international collaboration.
  • Existing clinical research infrastructure struggles to leverage the full potential of shared data.

Purpose of the Study:

  • To identify major obstacles to clinical study data sharing in Germany.
  • To propose feasible solutions to increase clinical study data availability.
  • To address barriers related to infrastructure, awareness, legal aspects, and responsibilities.

Main Methods:

  • Analysis of obstacles based on consulting researchers and international partners.
  • Development of six actionable recommendations for improving data sharing.
  • Focus on ethics committees, trial registries, infrastructure, and governance.

Main Results:

  • Identified significant barriers hindering clinical study data sharing in Germany.
  • Proposed six concrete steps to enhance data availability.
  • Recommendations address infrastructure, awareness, legal uncertainty, and responsibilities.

Conclusions:

  • A concerted action plan is needed to address the clinical study data sharing crisis in Germany.
  • Implementing the proposed measures would significantly improve data sharing rates.
  • Fostering data sharing skills, knowledge, and incentives is crucial for success.