[Registries for clinical trials -- a critical stock-taking]

Area of Science:

• Clinical research methodology
• Health informatics
• Regulatory science

Context:

• German working group proposed a national clinical trials registry.
• Consideration of existing registries, harmonization initiatives, and national registry creation requirements.
• Need to address multicentric and international clinical trials.

Purpose:

• To evaluate the feasibility and optimal strategy for establishing a national clinical trials registry in Germany.
• To harmonize clinical trial data and avoid redundant recording.
• To align with international standards and recommendations, such as those from the WHO.

Summary:

• The National Institutes of Health (NIH) trial registry is recommended as the primary clinical trials database.
• The NIH registry is publicly accessible, widely used globally, and contains approximately 23,500 clinical studies.
• A complementary national registry could be established, sourcing data directly from the international registry to minimize researcher burden.

Impact:

• Facilitates efficient data management for clinical trials, particularly international collaborations.
• Promotes data transparency and accessibility in clinical research.
• Supports harmonization of clinical trial data globally, enhancing research integrity and comparability.