Adoption of electronic work processes pushing convergence of electronic
health records and clinical trials
London, UK. A favourable legislative environment supporting improved
accessibility to patient data is encouraging the use of IT and
computer-based patient record systems across hospitals in Europe and North
America. At the same time, efforts to streamline the functioning of clinical
trials while reducing both cost and time to completion, are promoting the
expanded use of electronic data capture. Such trends are creating a suitable
environment to unify work processes in clinical care and clinical research
"The benefits of this integration are numerous and will validate
widespread initiatives by stakeholders, says Frost & Sullivan Research
Analyst Sumitha Kannan in a recent study on Convergence of Electronic Health
Records and Clinical Trials. "Although poor adoption and penetration of
electronic modes presents a challenge, it will be overcome by the need to
complement advances in pre-clinical research with similar, robust
improvements in clinical research areas."
The evolution towards integration of electronic patient records and
clinical trials is a certainty that will affect stakeholders in the clinical
research as well as clinical care areas. While the speed of such a change
might be difficult to forecast, it is nonetheless, projected to unfold over
the next five to ten years.
"The value attached to convergence in terms of increased efficiency, time
and cost-effectiveness will bolster widespread industry efforts to achieve
convergence of electronic health records (EHRs) and clinical trials," adds
Ms. Kannan. "The union of electronic data storage capabilities present in
clinical and healthcare communities alike, will help streamline patient
recruitment while eliminating redundant processes like transferring data
from the EHR to the EDC template for clinical trials."
Currently, several industry summits and conferences are attempting to
assemble a range of vendors who might benefit from convergence. These also
underscore the widespread perception amongst industry participants of the
need for unification. These have been accompanied by efforts to define
common standards as well as enhance and accelerate clinical trials by
linking them to national healthcare patient records networks.
However, the unsatisfactory rate of penetration of electronic patient
record keeping systems in hospitals and of electronic data capture modes in
clinical trials hinders the prospects of future convergence. Additionally,
low levels of user comfort with electronic modes, together with the
preference for more conventional paper-based methods, will negatively impact
the scope for convergence.
"A productive interlinking of electronic patient records for the purpose
of clinical research can occur only after the initial transition from
paper-based to a fully electronic workflow," cautions Ms. Kannan. "Moreover,
it is critical for hospitals and physicians to fully support and impel the
cause of convergence, although the benefit for hospitals and doctors
(physician investigators) might be a little indirect and slow to be
Despite these challenges, legislation mandating the use of computerised
systems and the growing unrest regarding the time lag in clinical research
will motivate a high rate of penetration of EDC and EHR in the initial
stages. It will subsequently open up the possibility of an integrated
EHR-clinical trials system.
"Healthcare IT vendors offering solutions for convergence need to make
such solutions an imperative among physicians and hospitals," observes Ms.
Kannan. "Ensuring compliance with standards to enable extensive cross
communication with existing patient data modalities will also be central to