Jeff Lee, product lead for patient engagement and eConsent at CRF Bracket, is speaking this week at the 10th Annual Summit of Clinical Operations Executives (SCOPE) in Orlando, FL.
In his session, Lee will talk about three solution areas: eConsent, eCOA, and patient engagement. While the barriers for adoption of these differ somewhat, the top three are adequate budget within the overall study budget, clear value proposition, and regulatory considerations.
“As an industry, we are enhancing our technologies so they can be delivered more efficiently,” said Lee. “We’re also seeing a gradual accumulation of case studies and journal articles demonstrating the positive impact of these technologies,”
Backed by these trends, Lee said the industry should have the validation to budget for technology appropriately. Still, the industry faces uncertainty as it pertains to the regulator's view of topics such as electronic signatures and Software as Medical Device (SaMD) regulations. Lee noted it could also be quite simply, a lack of support.
“This creates an opposing effect to the positive movement in the other areas,” he said.
Challenges, changes, and continued adoption
Implementing eConsent does pose its own set of challenges, including the provisioning of single-use devices to sites, gaining regulatory acceptance of different forms of electronic signature, and handling complex studies with disparate consent documents.
However, these are modest challenges compared to the overall scheme of eClinical technologies, said Lee. And yet, the adoption of eConsent remains in the low single-digits.
“This low adoption means that studies still struggle with protocol deviations due to poor protocol comprehensions, as well as critical regulator findings due to erroneous consenting activities, among other problems,” explained Lee.
Offered as a stand-alone solution, Lee said eConsent has limited opportunity to be adopted by studies moving forward.
“However, in the coming years, we will see eConsent delivered together with other solutions (like Patient Engagement, IRT, eCOA) such that it has a lower unique cost to the sponsor and therefore has a stronger ROI,” he said. “This will promote continued adoption to the point, within 5 years, eConsent will have surpassed where eCOA is today in terms of adoption.”