Modernizing the Data Infrastructure for Clinical Research to Meet Evolving Demands for Evidence

Area of Science:

• Clinical Research Informatics
• Health Data Science

Background:

• Clinical trial data access, acquisition, and usage systems have seen minimal evolution, leading to fragmentation and inefficiency.
• Current clinical trial data infrastructure is costly and labor-intensive, restricting the volume and quality of evidence generated.
• Despite advancements in electronic health records and data standardization, a unified approach to clinical trial data infrastructure is lacking.

Purpose of the Study:

• To propose a vision for a modernized clinical trial data infrastructure.
• To address the limitations of current data collection methods in clinical trials.
• To meet the growing demand for robust evidence from randomized clinical trials.

Main Methods:

• Conceptualizing a modernized infrastructure centered on collecting and evaluating multiple data sources and types.
• Envisioning a system that enables the reuse of health data for various purposes.
• Highlighting the necessity of multidisciplinary collaboration for infrastructure development.

Main Results:

• A framework for a modernized clinical trial data infrastructure is presented.
• The proposed infrastructure supports the integration of diverse data streams.
• Emphasis is placed on enabling data reusability across different research and clinical applications.

Conclusions:

• Modernizing clinical trial data infrastructure is crucial for enhancing evidence generation.
• The proposed vision facilitates rigorous evaluation of multiple data sources and promotes data reuse.
• Multidisciplinary collaboration and progress measurement are key to achieving this modernized infrastructure.