Survey: Well-defined eCOA strategies necessary in trial design stage
Thursday, March 3, 2016
Worldwide Clinical Trials conducted a global survey of 1,500 study coordinators and other staff responsible for patient assessments designed to deliver insight into the acceptance and perceptions of electronic clinical outcome assessment (eCOA) technologies during clinical trials at the site level.
The results revealed that 67% of respondents prefer paper-based assessments over eCOA solutions, with many citing concerns that these electronic solutions may interfere with the normal patient rapport that is required during the clinical assessment process. The findings highlight important considerations for the industry, with the need for easier interfaces, simplified set-up processes and comprehensive training—all vital in improving the usability and prevalence of these technologies.
“We developed this survey in response to anecdotal feedback from a number of sites that they were not happy about the move from paper to eCOA, and we wanted to confirm whether these perceptions were true across the industry,” said Douglas Lytle, Ph.D., executive director, Clinical Assessment Technologies at Worldwide Clinical Trials. “If sites are not accepting of a technology, they will resist its use, undermining efforts to increase data quality and consistency. Taking this time to understand the challenges our investigators face will help us all deliver more efficient, effective clinical trials that ultimately improve patient care.”
Many respondents were concerned that physical barriers presented by eCOA solutions when interviewing patients could impact the accuracy and integrity of data. Interestingly, study coordinators—versus clinical raters—were more likely to express satisfaction with the switch to eCOA. This may reflect how this technology can facilitate trial operations by coordinators, whereas raters may perceive challenges when implementing the technology directly with a patient, where both structure as well as sensitivity is required.
The findings of this Worldwide Clinical Trials study demonstrate the importance of well-defined eCOA strategies at the clinical trial design stage. Understanding site perceptions and incorporating these at the initial stages of a trial will ensure the technology enables rather than encumbers trial processes, positively impacts outcomes, and will help pave the way towards industry-wide acceptance at all levels of the research team.
“The transition to electronic solutions in any area of medical care and clinical research takes time. Electronic data capture (EDC) technologies, for example, took 10+ years for full adoption within the industry. We are in a similar position with eCOA, making collaboration and sharing of best practices essential,” said Dr. Michael Murphy, chief medical & scientific officer, Worldwide Clinical Trials. “By working with sites and understanding the unique perspective of clinicians responsible for patient management, we can provide investigative staff with the training and knowledge needed to embrace eCOA over time, and facilitate the process of accurate, and clinically meaningful data acquisition.”