Table 1

Recommendations to address practical challenges in clinical and biomarker data sharing

InfrastructureEarly planning of the interactions and common technology between legal/contractual teams and other technical project architects/regulators to facilitate mutual agreements and enhance the clarity of informed consent documents
Educating key medical/technical personnel involved in handling biospecimens to ensure timely collection and processing of samples
Shared cloud-based storage space with real-time access and supercomputers in academic centers (with HIPAA compliance and resilience) to allow multi-core computational analyses that can be accessed by multi-center collaborators
TechnologySelection of standardizable technological platforms for generation of comparable data
Use of supplemental bridging/ring studies to compare data-generating platforms and assess reproducibility and feasibility of data output harmonization across technologies
Establishment of patterns of patient response profiles to guide future response criteria and trial end points
WorkforceImplementation of a data standards workflow process that allows data sharing to be meaningful and undertaken in a responsible manner
Availability of personnel encompassing a broad range of expertise to enable an end-to-end workflow, including well rounded oversight of regulatory, scientific, curation, and bioinformatics aspects of research
Targeted and well-supported training of expert data planning and data management personnel
SustainabilityCreation of data-sharing models where the costs of maintaining data and data-sharing resources can be better acknowledged and equitably distributed across end users
Better defined cost factors, including required human resources for data sanitization and organization for comparability, in addition to infrastructure costs for storage and transfer
Bioinformatics tools used to read raw data files must be available long-term, and reliable readability tools should be maintained and provided in containerized formats
Increased recognition by academic promotion committees to incentivize data sharing
Publishing journals encourage data sharing whenever legally and ethically possible, according to Findable, Accessible, Interoperable, and Reusable (FAIR) guiding principles 56
  • HIPAA, Health Insurance Portability and Accountability Act.