eConsent adoption is expected to increase by at least 30% CAGR for the next three years, according to a recent report by CRF Health.
The ‘State of eConsent’ survey also reported that 55% of respondents’ organizations will adopt eConsent in 2017, rising to 82% by 2020.
Additionally, 76% of respondents view the ability to create the eConsent in-house without vendor involvement as one of the top design functionalities, and 80% said the ability to deploy eConsent to sites using digital tablets is a key priority.
“It is clear that eConsent adoption is on the rise and that industry early adopters already exist,” Sandra Sather, Regulatory and Quality, TrialConsent at CRF Health, told Outsourcing-Pharma.com, adding that 33% of respondent organizations are currently using eConsent in some form.
However, of those currently using eConsent, Sather said ROI is not yet clear.
“Adoption outlook appears very positive for the next 12 to 36 months, and additional data is needed in support of product claims such as ROI that will expedite adoption,” she explained.
Sather said the survey confirms that the top drivers for eConsent adoption are improved interactivity, comprehension, and compliance by study participants.
“There is also a clear need for reporting and analytics within the entire informed consent process, so that stakeholders can understand what parts of the consent participants have questions about, measuring what parts they do not understand, and capturing feedback on why they choose not to consent,” she added.
Additionally, Sather said stakeholders are looking for a solution that is less burdensome. “A solution that allows them to design and develop the eConsent without requiring 3rd party vendors and streamlining the process, not duplicating efforts, is very desirable,” she explained.
The report also found that the ability to consent remotely was less important to the respondents (25%) than expected, which Sather said was surprising, as one of the early drivers of eConsent was remote consent.
An encouraging outlook
Sather said CRF Health is excited to see the number of groups planning for the future adoption, which was greater than expected. “The outlook for adoption is very encouraging,” she added.
However, with the release of the FDA and OHRP Guidance at the end of last year, the company anticipated an increased interest in the US, but Sather said more “triggers for adopting” outside the US are still needed.
One such “global catalyst” for increased adoption will be the TransCelerate BioPharma eConsent guideline to be released this year.
“The adoption of an electronic system to obtain and manage consent requires stakeholders, sponsors/CROs, sites and ethics committees, to evaluate their current processes and other elements of their quality system to identify an implementation strategy,” Sather said.
"Technology has become an integral and prolific part of modern clinical trials, and the last thing anyone working in clinical trials really wants is an implementation of yet another technology platform, but we as an industry can’t be as slow to adopt these kinds of solutions as we were with technologies like eCOA and EDC."