This webinar
will provide an overview of the Clinical Research Track plans for the New
Orleans Connectathon. The Clinical Research Track will continue to further
explore the benefits of FHIR for clinical research of new biopharmaceutical
experimental treatments, and to increase visibility of FHIR within the
biopharmaceutical community. This track advances the use of FHIR resources as
eSource data used to pre-populate clinical research case report forms for both
regulated and non-regulated clinical research. This builds on previous
explorations in Connectathon 13-16. Plans for this connection include
participation from at least 5 Pharmaceutical companies, Members of
TransCelerate Biopharma, Inc. and technology implementers will simulate using
FHIR to populate and manage clinical study databases. A set of 2-3 detailed use
case scenarios will be proposed. This work will inform development of profiles
and Implementation Guides to support clinical research using FHIR.
Clinical Research studies currently require the
redundant entry of clinical data that already typically reside in Meaningful
Use conformant EHR systems. EHR data represents original records in electronic
format that can be used as eSource and directly imported into clinical research
EDC databases so as to improve the quality and consistency of data between EHR
and EDC systems and eliminate the need for redundant data entry and to improve
the ability to use real world data in research. Establishing interoperability
between EHR and EDC systems to streamline and modernize clinical investigations
should improve data accuracy, patient safety, and clinical research efficiency.
Given the extreme cost and extended time required for randomized clinical
trials, it would be substantially better to utilize EHR source data to directly
populate clinical trial databases wherever feasible and to use FHIR to gain
increased visibility into patient encounters and patient-originated data. As stated in its May
2016 FDA draft guidance titled “Use of Electronic Health Record Data in
Clinical Investigations” FDA “encourages sponsors and clinical investigators to
work with the entities that control the EHRs, such as health care
organizations, to use EHRs and EDC systems that are interoperable. Establishing
interoperability between EHR and EDC systems to streamline and modernize
clinical investigations should improve data accuracy, patient safety, and
clinical research efficiency.”