Surveying the State of eConsent: Are There Still Barriers to be Broken Down?

Electronic informed consent (eConsent) is quickly making a name for itself as the next big technological innovation in clinical trials. With regulators, academic research centers and industry groups advocating its impressive benefits, it is no surprise that many of the major pharma companies are engaged in or are currently planning an eConsent initiative. To dig a little deeper into the industry’s attitudes towards eConsent, CRF Health conducted a survey to benchmark its current use, better understand adoption hurdles and challenges, and anticipate market growth.

The survey, which captured the opinions of 146 respondents from 100 biotech, pharmaceutical, CRO and IRB organizations, revealed that the major factors driving eConsent adoption today are the opportunities brought by enhancing understanding and improving overall participant satisfaction. Indeed, the momentum of adoption looks set to continue with 55% of respondents saying that their organizations will adopt eConsent over the next 12 months, rising to 82% by 2020.

From a design and functionality perspective, 85% of respondents reported that interactivity was the most highly valued eConsent engagement functionality. This is in line with what the U.S. Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) agencies stated in the December 2016 guidance document on the use of electronic consent in clinical trials. It was noted that “electronic processes to obtain informed consent may use an interactive interface, which may facilitate the subject’s ability to retain and comprehend the information.” (OHRP FDA Guidance eIC 2016)
 
As is expected from new technology, perceived high costs and uncertain ROI are still proving to be a barrier and preventing some organizations becoming early adopters, while many also want to see more evidence and education to prove the true value of eConsent before making the switch. With 10 of the top 10 pharma companies already having an eConsent strategy in place and industry groups like the Clinical Trials Transformation Initiative (CTTI) and Transcelerate Biopharma noting benefits for adoption, we’ll increasingly see more and more data coming out of live trials employing eConsent, and, as a result, we’ll have the information to support the claims.

Perhaps giving a more revealing glimpse into the industry’s current mindset, the ability to deploy an eConsent solution without vendor involvement was cited as a key priority for most stakeholders. The reliance on outside vendors to design and program eConsent can slow down implementation and create longer timelines in making the eConsent ‘live’. Consequently, sponsors and CROs are looking for adaptable solutions and support models that enable them to control and manage the design, development and deployment of eConsent without the need for continuous vendor support.  

Reflecting on the findings of the survey, it’s clear that eConsent is on the strategic roadmap for most organizations. What has been shown, however, is the need for flexible solutions that sponsors and CROs can design independently without requiring programming support. To be long lasting and mainstream, eConsent has to be adaptable, and organizations should be looking for the solutions that can put the design and deployment firmly in their own hands.  

For further information on CRF Health’s solutions, please visit www.crfhealth.comSandra (Sam) Sather, Regulatory & Quality, TrialConsent at CRF Health