Title: eSource for clinical trials: Implementation and evaluation of a standards-based approach in a real world trial,
Abstract: Objective: The Learning Health System (LHS) requires integration of research
into routine practice. eSource or embedding clinical trial functionalities into
routine electronic health record (EHR) systems has long been put forward as a
solution to the rising costs of research. We aimed to create and validate an
eSource solution that would be readily extensible as part of a LHS.
Materials and Methods: The EU FP7 TRANSFoRm project's approach is based on
dual modelling, using the Clinical Research Information Model (CRIM) and the
Clinical Data Integration Model of meaning (CDIM) to bridge the gap between
clinical and research data structures, using the CDISC Operational Data Model
(ODM) standard. Validation against GCP requirements was conducted in a clinical
site, and a cluster randomised evaluation by site nested into a live clinical
trial.
Results: Using the form definition element of ODM, we linked precisely
modelled data queries to data elements, constrained against CDIM concepts, to
enable automated patient identification for specific protocols and
prepopulation of electronic case report forms (e-CRF). Both control and eSource
sites recruited better than expected with no significant difference.
Completeness of clinical forms was significantly improved by eSource, but
Patient Related Outcome Measures (PROMs) were less well completed on
smartphones than paper in this population.
Discussion: The TRANSFoRm approach provides an ontologically-based approach
to eSource in a low-resource, heterogeneous, highly distributed environment,
that allows precise prospective mapping of data elements in the EHR.
Conclusion: Further studies using this approach to CDISC should optimise the
delivery of PROMS, whilst building a sustainable infrastructure for eSource
with research networks, trials units and EHR vendors.