NIH HEAL Clinical Data Elements (CDE) implementation: NIH HEAL Initiative IMPOWR network IDEA-CC.

Area of Science:

• Biomedical Research
• Clinical Trials
• Data Science

Background:

• The National Institutes of Health (NIH) HEAL Initiative invests heavily in pain and opioid-use disorder research.
• Making research data findable, accessible, interoperable, and reusable (FAIR) is crucial for maximizing this investment.
• Standardizing common data elements (CDE) is a key strategy for achieving data FAIRness in clinical research.

Purpose of the Study:

• To describe the selection, processing, harmonization, and design constraints of CDE within the NIH HEAL IMPOWR clinical trials network.
• To detail the implementation of newer data standards for pain and opioid use disorder research.

Main Methods:

• Network alignment to incorporate advanced data standards.
• Implementation of geographic coding (RUCA), deidentified patient identifiers (GUID), and shareable clinical survey libraries (REDCap).
• Concept mapping to standardized terminologies (UMLS) for data harmonization.

Main Results:

• Successful incorporation of newer data standards across the clinical trials network.
• Specific advances include RUCA for geographic coding, GUID for deidentified patient identifiers, REDCap for survey libraries, and UMLS for concept mapping.
• Demonstrated feasibility of network alignment for data standardization.

Conclusions:

• Harmonization of CDE across diverse clinical trials for pain and opioid use disorder is achievable and optimizes data standardization.
• Standardized data supports robust secondary analyses and can inform coverage decisions by insurance companies and government organizations.
• Leveraging tools and technology can simplify CDE implementation and promote wider adoption of consistent data standards.