Electronic Integration Costs

Some of the most important issues facing our industry today center on the true role of electronic data capture (EDC). Should it be considered part of electronic health records (EHR)? Who owns the integration of IT data management across clinical trials and patient records in clinical science—and how should the costs be covered?

These were only a few of the questions that arose following a survey conducted by the eClinical Forum last year measuring the global use of EDC in clinical trials—a follow-up to a similar survey conducted in 2001. Of course the world is a bit flatter now than it was then, and the facilitators expected that the data would reflect some significant changes in the industry.

Yet, when the final results were analyzed, what they revealed was still surprising. In particular, despite current pressure on the industry to connect health care and clinical trial systems, and to improve efficiency in care, treatment, and documentation for patients and trial subjects, clinical trials and patient health records still cited an 80% to 100% data input duplication rate.

Seeing the benefits

Over the years, the balance has shifted in who does the actual electronic data collection at clinical sites. In 2001, EDC input was primarily an activity of clinical investigators; today, study coordinators are doing nearly all of the data entry. EDC has become an activity of site staff study nurses and coordinators—and it is more accepted as a normal ongoing function of data collection and recordkeeping in clinical trials.

This trend reflects increased awareness of the benefit in connecting electronic health records and clinical trial systems. Survey respondents were overwhelmingly in favor of automatic transfer of data—a clear sign of a cultural shift toward acceptance of IT as a means of improved efficiency in both medical care and clinical trial systems. Among the pivotal questions here, of course, is who will pay for the linking of data between systems?

The future of EDC

There are two different industries and two different software environments at play here as stakeholders. Some part of the industry must support the need for electronic health record data to be easily standardized and coordinated, and to pay for the cost of linking these systems.

Insurers, pharmaceutical companies, and other users of electronic medical data are beginning to shoulder the expense of such information sharing.

The European Union governments have invested some €3 million for a pilot project to address redundancy in data collection; €12 million are to be allocated next year, with the cost to be split evenly between governments and pharmaceutical companies in Europe. So pharmaceutical companies are beginning to look into this issue and play a more active part in bridging the two worlds. These are good first steps, but so much more needs to be done.

Getting connected

The recent eClinical Forum survey has shown us that there is still an endemic inefficiency in health care and clinical trial record connectivity. For the good of the industry as a whole, we all must look at the value that integrating EDC and EHR provides, and urge stakeholders to invest in this technology as a means of improving recordkeeping and taking the relationship to the next step.