Sufficiency of Japan's Future Public Databases in Capturing Data Items for Clinical Trials

Area of Science:

• Clinical research informatics
• Real-world data infrastructure
• Prospective clinical trials

Background:

• Japan is developing real-world data (RWD) infrastructures.
• Assessing data availability for clinical trials is crucial for RWD integration.

Purpose of the Study:

• To evaluate the availability of trial-level data items within Japan's RWD infrastructures.
• Focus on data required for prospective clinical trials, specifically Phase III.

Main Methods:

• Extracted data items from 2022 Phase III clinical trials in Japan.
• Assessed availability of target disease, inclusion/exclusion criteria, and primary endpoint data.
• Evaluated data from electronic medical records and national databases.

Main Results:

• Target disease data was available for 95.8% of trials.
• Inclusion/exclusion criteria data was available for 63.6%.
• Primary endpoint data was available for only 18.8% of trials, with only 4.8% meeting all criteria.

Conclusions:

• Significant gaps exist between clinical trial data needs and Japan's current RWD infrastructure.
• The RWD initiative is in its early stages, with expectations for future improvements.