Potential strengths and limitations of clinical trial data-sharing models
| Data-sharing mechanism | Examples | Strengths | Limitations |
|---|---|---|---|
| Pharmaceutical company or sponsor-based secure portal for analysis | Clinicalstudydatarequest.com | Data remain secure, and analyses can be monitored by trial sponsors. | Execution of proposal review and data use agreements can be time-consuming. |
| Third-party dataholder+secure portal for analysis | Yale Open Data Access project | Scientific merit of proposed secondary analyses can be vetted by experienced, third-party investigators. | Execution of proposal review and data use agreements can be time-consuming; potential for demonstrating inaccurate or misleading results; privacy concerns for rare diseases and in very elderly. |
| Data available for download and analysis may be conditional on evidence of local institutional review board approval | National Institute of Health Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC); European Medicines Agency | Broadest access to data, which may facilitate new discoveries more quickly; concerns for analytical overlap were not borne out by 2017 SPRINT Open Data Challenge experience. | Potential for demonstrating inaccurate or misleading results; privacy concerns; conflicts of interest may not be fully vetted prior to data sharing. |
| Fee-for-service data sharing with trialists | No examples known at present; concept raised by International Consortium of Investigators for Fairness in Trial Data Sharing | Trialists are compensated for their work in the primary trial. | Investigators from low resource groups or settings may be inherently limited in accessing these data. |