Sticking with tradition: clinical trial sites prefer paper records

By Melissa Fassbender contact

- Last updated on GMT

Many named concerns that the electronic solutions may interfere with patient rapport. (Image: iStock)
Many named concerns that the electronic solutions may interfere with patient rapport. (Image: iStock)

Related tags: Clinical trial

According to a recent survey, the majority of clinical trial site staff prefers paper-based assessments over eCOA solutions.

The survey, led by Worldwide Clinical Trials, included input from 1,500 study coordinators and other staff responsible for patient assessments, and was conducted to better determine attitudes surrounding eCOA technologies at clinical trial sites.

The company developed the survey after receiving feedback from various sites that were not happy with the move from paper to eCOA.

"We understood that eCOA technologies have shown that they bring additional reliability and reduction of variability in CNS outcome assessments. However, we had heard anecdotally from some sites that they were not accepting of these technologies​," Douglas Lytle, Ph.D., ‎executive director, Clinical Assessment Technologies at Worldwide Clinical Trials told Outsourcing-Pharma.com.

"If sites are not accepting of a technology, they will resist its use, undermining efforts to increase data quality and consistency,” ​he added.

According to the company, 67% of the respondents prefer paper-based assessments over eCOA solutions, and many named concerns that the electronic solutions may interfere with patient rapport.

"The most surprising finding was the strength of the preference for traditional, paper-based assessments at the sites​," explained Lytle.

Additionally, several respondents expressed concerns that the physical barriers presented by eCOA solutions could impact data accuracy and integrity. Study coordinators, as opposed to clinical raters, were also more likely to be satisfied with the switch to eCOA.

Lytle also explained that for most eCOA technologies, there was no strong preference or dislike for a particular device. Yet, "there are many factors to carefully consider when sponsors decide between using eCOA technologies or traditional, paper-based assessments​," he added, explaining that the survey helped the company better understand related issues and how they might address them.

"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," ​added Dr. Michael Murphy, Chief Medical & Scientific Officer, Worldwide Clinical Trials. "We are in a similar position with eCOA, making collaboration and sharing of best practices essential."

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