Better access to information about clinical trials.

Area of Science:

• Biomedical Informatics
• Public Health
• Clinical Research

Background:

• Access to clinical trial information is crucial for researchers, healthcare professionals, and patients.
• Existing clinical trial registries face challenges in comprehensiveness and accessibility.
• There is a recognized need for a centralized, publicly available system for clinical trial data.

Purpose of the Study:

• To review existing clinical trial registries, their benefits, and challenges in development.
• To introduce and describe the features of the newly developed ClinicalTrials.gov registry.
• To highlight the importance of informatics principles in registry design and implementation.

Main Methods:

• Review of existing literature and systems for clinical trial registration.
• Description of the development process for ClinicalTrials.gov, adhering to informatics principles.
• Inclusion of usability considerations and iterative testing in the system's design.

Main Results:

• ClinicalTrials.gov, a comprehensive Web-based registry, was launched in February 2000.
• The initial version contains approximately 5000 trials, primarily NIH-sponsored.
• Future versions will expand to include trials sponsored by other federal agencies and the private sector.

Conclusions:

• ClinicalTrials.gov represents a significant advancement in public access to clinical trial information.
• The registry's development emphasizes adherence to standards, usability, and iterative evaluation.
• This initiative addresses the legislative mandate for a comprehensive, publicly accessible clinical trials registry.