Information technology

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 areas.

"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 perceived."

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 success."

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