Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (ePRO), commonly known as patient diaries and Clinical Outcome Assessments (eCOA) have gained traction in the clinical research industry over the past 15 years, where the adoption of technology for data capture in clinical trials has maintained an upward slope.
The growth of EDC and ePRO is driven by several factors, including ease of use, superior accuracy of data and instant access to supplied data that can drive clinical decisions and improve compliance with protocol requirements as well as standard operating procedures. A recent report by ISR entitled “EDC and eCOA/ePRO Market Dynamics and Service Provider Performance” (2015) provides a deeper insight into the increasing technological trend of EDC and ePRO/eCOA penetration into pharmaceutical markets and the driving forces behind it.
Electronic Data Capture systems have matured since their inception nearly 15 years ago, where software workflows have been polished to suit patient management, trial management as well as data collection and reporting processes. Given the usability of EDC systems, where data is easily input and can be securely accessed from anywhere, it comes as no surprise that ISR’s report found that 91% of clinical research professionals prefer EDC applications over paper.
A strong driving force behind EDC, ePRO and eCOA adoption is the superior data accuracy that these electronic technologies provide over paper. EDC and ePRO systems implement point-of-entry data validation to ensure that the data provided is within the appropriate ranges as outlined in the study protocol, as well as that data entry is complete. Ensuring data accuracy and completeness saves a tremendous amount of time typically spent throughout a paper based trial on data transcription and query resolution.
Finally, the data supplied electronically via EDC, ePRO and eCOA can be viewed instantly and accessed from anywhere. The main advantage of real-time data is that the patient condition can be monitored more closely and drive decisions pertaining to that patient’s care, as well as monitoring compliance with data input and standard operating procedures, which ensures any potential issues are spotted before they can impact study outcome.
ISR’s report indicates that the majority of clinical research professionals intend to increase their use of EDC and ePRO in the near future. Therefore, it is only a matter of time before paper-based trials become obsolete.
HealthDiary provides Electronic Data Capture (EDC), Patient Diaries (ePRO) and Patient Registry services to Biopharma and CRO organizations. To learn more about our services, please contact us today.