March 20, 2018

Electronic informed consent: The star bench-warmer?

The Pulse on Technology by Elisa Cascade

“If you build it, they will come.” While this was clearly the case in the baseball film “Field of Dreams,” the same does not hold true for all site-facing clinical trial technology. As the last Pulse on Technology column highlighted, several technologies are still sitting on the bench when it comes to use across all trials. This column takes a closer look at the technology with the lowest awareness and adoption: electronic informed consent (eConsent). To continue the baseball analogy, picture eConsent as a little boy sitting on the bench waiting to get into the game.

When it comes to “readiness to play,” eConsent has many features that could positively impact the efficiency of clinical trial conduct. It improves the consent process for the patient through the use of interactive elements including combinations of video and audio narration, illustrated glossary terms and enabling patients to highlight areas they have questions about for discussions with sites. Research has shown that patients who are presented with eConsent better understand the purpose and process of the trial, which, in turn, correlates with a higher patient retention rate.

eConsent can also benefit sites in a number of ways, such as having the consent written in patient-friendly language, always surfacing the most up-to-date version of the informed consent form, electronically recording the date/time/version of consent and by helping sites use their time with the patient more productively. In addition to ensuring that the patient is presented with a comprehensive description of the informed consent, sites are able to identify where patients are having trouble with the consent language and can focus their discussion more specifically on those areas. Indeed, in the 2016 DrugDev Annual Investigator Survey, the majority of global investigators agreed that eConsent would decrease site burden and be easier to use than paper consent.

Despite these positive attitudes, however, eConsent remains on the bench; only 28% of global sites have used eConsent on at least one study, with 2% of sites reporting use across all studies. And despite the baseball analogy, the low level of experience with eConsent is true across all countries (similar to being on the “subs bench” in a football/soccer match): Argentina, Australia, Brazil, Germany, India, South Africa, the U.S. and the U.K. all reported use by between 20% and 30% of sites. India and South Africa had the lowest levels of experience with eConsent (19% and 5%, respectively).

So why is eConsent still stuck on the bench given its potential to positively improve patient retention rates? Anecdotally, concerns have been raised regarding ethics, site burden and patient acceptability, but when directly asked, “Why have you not used eConsent on all clinical trials,” 77% of global sites responding to the 2016 Annual Investigator Survey reported that they had not been asked by the study sponsor. Less than 15% of sites actually expressed material concerns; 12% said that their local IRB or ethics board did not approve the use, 7% thought that the technology would be unacceptable to patients and 6% thought it would be difficult to incorporate into their site workflow.

It is clear from the research that sites are open to getting eConsent onto the field of play and using the technology. They just need to be asked! Providing education and support to sites should speed the progression from awareness to trial to adoption where the patients, sites and sponsors can all benefit. So the message on eConsent could well be summed up as, “Put me in coach. I’m ready to play today!”