The Clinical Research Data Hub (CRDH), organized within the International Center for Health Outcomes and Innovation Research at Mount Sinai in NYC (InCHOIR), provides support in overall management and coordination for all RMIC components. The CRDH is developing web-based tools for data collection, clinical trial progress tracking, and linkage of cell data to clinical data, leading to further research and patient treatment using adult stem cells in the future.
The CRDH is developing Common Data Elements (CDEs), which are standardized key terms used to enhance the quality, reproducibility and consistency of data collected across research studies. Development and use of CDEs will help to standardize and facilitate the sharing of data, reduce the complexity of designing new research studies, promote collective use of common terminology, and accelerate new scientific research discoveries.
- Clinical trial characteristics, such as type of study, recruitment status, study phase, etc.
- Individual patient data, including demographic and clinical characteristics, clinical outcomes and biological measurements
- Cells and cellular products data, including cell characteristics, critical process parameters, and cell product quality attributes
- Preclinical data, including critical process parameters, animal model characteristics and outcomes data.
In the field of regenerative medicine, CDEs may provide a unique opportunity to link specific attributes of cell therapies and other regenerative medicine products with patient-related factors. This would enhance our understanding of the complex relationship between cell therapies, disease states, the host and the environment.