The Paperless Trial – Past, Present and Future

Electronic data capture (EDC) and the electronic health record (EHR) are radically changing the ways the pharmaceutical industry manages clinical research data and physicians manage their patients. EDC allows the users at clinical research sites to enter, review and analyse data in real-time, whereas the EHR allows users at a clinic or hospital to do the same. While these two functions are very similar in both structure and function, adoption of these systems is still relatively slow, especially in the US (1,2).

From the clinical research perspective, there is no functional integration of EHR and EDC (3). One result is that, whether the clinical trial is being performed using EDC or a paper case report form (CRF), there is a loss of efficiency when a study site has an EHR. While adoption of the EHR and EDC is still lagging behind, there is no question that EDC and the EHR are here to stay. When properly designed, EHR and EDC solutions offer a convenient, cost-effective approach for the clinical sites to enter data, manage data and generate reports.

In the pharmaceutical industry today, EDC offers clinical research associates (CRAs) the ability to review data prior to visiting the study site, monitor the data electronically onsite and resolve queries electronically. EDC also allows data managers to assure data quality more effectively by having online data validation checks. Project managers are also able to evaluate the study status in realtime. Back in 1997, Kelly and Oldham discussed the challenges for the implementation of an Internet-based clinical trial, as well as the obvious advantages of its use in drug development (4). Chadwick and Gisanti (5) gave a vision into the future and Garvey (6) addressed EDC as state-of-the-art technology. Several publications by Mitchel et al (1,7,9,10) documented many of the advantages of EDC over paper CRF-based studies.