Recommendations to address practical challenges in clinical and biomarker data sharing
| Challenge | Recommendation |
| Infrastructure | Early 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 | |
| Technology | Selection 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 | |
| Workforce | Implementation 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 | |
| Sustainability | Creation 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.