Advancing PTSD-Substance Use Comorbidity Treatment Research Through Applying FAIR and FACT Data Science Frameworks in...

Area of Science:

• Data Science
• Clinical Research
• Public Health

Background:

• Research on posttraumatic stress disorder (PTSD) and substance use disorder (SUD) treatments faces challenges due to inconsistent data and governance issues.
• This limits data synthesis and the translation of findings into clinical practice.

Purpose of the Study:

• To describe how integrating FAIR (Findable, Accessible, Interoperable, Reusable) principles and FACT (Fairness, Accuracy, Confidentiality, Transparency) concepts can strengthen PTSD-SUD data science.
• To illustrate these principles using Project Harmony's individual participant data meta-analysis (IPD-MA) as a case example.

Main Methods:

• Identified barriers in PTSD-SUD clinical trials and mapped FAIR+FACT practices across the research lifecycle.
• Applied strategies including common data element (CDE) labeling, interoperable harmonization pipelines, and transparent documentation within Project Harmony's IPD-MA.

Main Results:

• FAIR+FACT alignment enhances reproducibility and validity while minimizing participant risk, especially for vulnerable populations.
• Project Harmony demonstrated the feasibility of large-scale harmonization and measurement equivalence, supporting comparative effectiveness analyses.

Conclusions:

• FAIR+FACT integration provides a practical framework for trustworthy PTSD-SUD treatment evidence.
• Recommendations are provided for investigators, networks, and policymakers to institutionalize FAIR+FACT requirements for ethical and reusable datasets.
• Adoption of interoperable standards, documentation, code sharing, and trauma-informed governance can accelerate guideline development and improve clinical decision-making for comorbid PTSD and SUD.