The traditional piecemeal record-keeping approach is notoriously flawed and leads to a great number of treatment errors. In
fact, the improvement of this situation—and easy accessibility to the information—is one of the reasons for the introduction
of the EMR and EHR systems. But without process and control changes similar to clinical research controls, the goal of improving
the accuracy of healthcare information may remain an elusive one.
Control of data is difficult to achieve In clinical research, source data are transcribed onto the required paper case report forms (CRFs) or into the EDC system.
It is the physician's responsibility to prepare and maintain the source data, and the sponsor's responsibility to ensure the
reported trial data are accurate, complete, and verifiable from source documents. To ensure the accuracy of this process,
sponsors usually carry out a process called source data verification, in which CRF records are manually compared to the corresponding
But who retains physical control over data, whether on paper or electronic? FDA defined its current position in its February
2006 Draft Guidance on Patient Recorded Outcomes. This guidance states that sponsors must not have exclusive control of the
source document, there must be more than one database, and investigators must be accountable for the accuracy of the data.
The issue at hand, however, is that current EDC systems are often hosted by sponsors or third parties over the Internet. If
such EDC systems develop into or integrate with EMR/EHR systems, this model would no longer be viable, as it would make the
sponsor the sole custodian of the dataset.
Despite an unclear regulatory environment and the lack of accepted standards, organizations still see value in using eSource.
The following examples illustrate how groups are coming to terms with the convergence of electronic healthcare and EDC through
innovative pilots and experiments.
Eli Lilly conducted what is believed to be one of the first trials completely run over the Internet for an Investigational New Drug.
In late 2001 and early 2002, with FDA's approval, the company used the Internet to gather data from patients, and formulated
EHRs. The information was hosted by a third party, which transferred the depersonalized data to Lilly for statistical analysis
Patients enrolling for the trial were required to have a home computer with access to the clinical trial Web site. While it
is not clear how this might have biased the selected patient population, it did demonstrate that such online trials are feasible
and can be compliant with regulations. However, it did not eliminate the problem for investigators who work with several sponsors—with
each organization maintaining a different electronic record database, all separate from the investigator's non-clinical trial
Johnson & Johnson is performing Phase I trials with tablet PCs, taking advantage of the devices' mobility to make it easier for physicians
to enter data directly—and thus eliminate a separate source. The data entered into the tablets do not reside there, but go
directly to a local onsite server, and then are transmitted to J&J's central server.
The Karolinska Institute has reported on pilots involving retrospective mining of data. In these pilots, the organization retrieves large amounts
of pre-existing data from EMR databases and analyzes them quickly. Although these pilots used retrospective collection of
data, they did demonstrate that transfer of eSource data to a sponsor for clinical trial analysis is feasible, and that this
process could realize efficiencies. It also showed, since the data was exported from the EMR, that it could be controlled
to protect patients' privacy.
Siemens Medical Solutions, an EMR vendor, is currently conducting a pilot with the Technical University of Munich that includes back-end integration,
enabling the automatic transfer of data from EMRs into an EDC system.
The Clinical Data Interchange Standards Consortium conducted a proof-of-concept pilot on generating both medical records and clinical trial databases using a single point of
entry. Instead of entering data into the EMR and EDC system directly, clinicians relied on a dedicated "entry application,"
which maintains the proper regulatory control of the data and uses it to populate the appropriate databases.