Project ScopeIncreasing interest in eSource keeps the issue of data integration between Research Systems (EDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) as a consistent want for Sponsors of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with wide-scale adoption, for a variety of reasons. Some common historical points of view have included: - That the quality of the data that can be retrieved from the Healthcare sites is insufficient to meet research needs.
- That uptake of electronic systems at investigative sites has been slow, expensive, and not delivering real value to healthcare practises.
- Types of data captured in healthcare have been more operational rather than clinical.
- Enabling the Necessary interfaces is an expensive and process-heavy undertaking.
- There is not a suitable, generally supported electronic exchange format, with a number of standard representations being supported in recent memory.
Many of these issues are on the path to being resolved; government programs have pushed the adoption and accessibility of electronic health records. In addition, there are a number of stakeholders in the Research Industry that are making the use of healthcare resources a priority for the future; examples include Transcelerate eSource initiative and HL7 Vulcan Accelerator. |