Abstract
Precision medicine practice requires an understanding of the similarities and difference between disease processes in individuals. To test a hypothesis or validate a biomarker in a retrospective study inherently requires clear criteria to define the disease state. The large datasets required for current “omics” analyses often require building cohorts from multiple sources of specimens, data, or patients. The disposition of research work product often carries implications of data governance, intellectual property rights, and commercial revenue that can derail well-intentioned and well-designed studies. Increasingly, stakeholders in the process are focused on nonscientific considerations that are not tractable with scientific tools but require scientific understanding to solve. In this chapter, we provide a number of vignettes illustrating the opportunities and challenges inherent in building such chimeric cohorts across organizational boundaries and showcasing tools useful in building fit-for-purpose collaborations that can satisfy scientific, clinical, ethical, and commercial objectives.
Original language | English |
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Title of host publication | Comprehensive Precision Medicine, First Edition, Volume 1-2 |
Publisher | Elsevier |
Pages | V2-264-V2-282 |
Volume | 1-2 |
ISBN (Electronic) | 9780128240106 |
DOIs | |
State | Published - Jan 1 2023 |
Keywords
- Biorepository
- Cardiology
- Cardiomyopathy
- Chronic disease
- Clinicogenomic
- Data governance
- Data sharing
- Genome-wide association studies
- Genomics
- Next generation sequencing
- Pharmacogenomics
- Precision medicine
- RNAseq
- Real-world data