Despite having many features with the potential to powerfully benefit clinical research teams, eConsent remains the clinical trial technology with the lowest rate of awareness and adoption.
Given its potential to streamline the informed consent process, boost patient centricity, and help lower a given study’s dropout rate, it is surprising that so many clinical research sites have not yet adopted any form of eConsent technology. This year, eConsent is worth the investment – more than ever.
Benefits of eConsent
The FDA requires clinical trial sponsors and physicians to provide patients with adequate information to make an informed decision. In the past, our industry has turned to lengthy consent forms in order to meet these regulations. The goal was always to get the participants to sign the forms, with little concern as to whether they actually understood what they were signing.
However, a patient who feels confused or misled is not a happy patient. In fact, a recent CISCRP survey reported that 35% of patients who dropped out of a study said they felt the consent document was difficult to understand. This is not surprising, since paper consent forms are often intimidating documents containing medical jargon that most people outside of the industry don’t understand. Not to mention that they can be over 30 pages long!
eConsent, on the other hand, utilizes simpler, more engaging forms of communication. These can include:
- Audio narration
- Illustrated glossary terms
- Interactive features allowing patients to highlight topics they’d like clarified further
- Interactive quizzes
- Progressive disclosure, or more digestible chunks of text
- Video narration
Studies show that patients who sign through eConsent forms rather than struggling through paper consent forms gain a significantly better understanding of the trial. This is correlated with a higher patient retention rate, presumably because patients feel more educated, appreciated and empowered. Not only do these positive feelings cause them to see the trial through, but they also make it far more likely that the individual would partake in a future trial or relay the experience in a positive light when talking to others.
Clearly, eConsent is a far more patient-centric way of doing things; moreover, it makes things more effective on the researchers’ end of things too.
First of all, eConsent enables investigators to track what parts of the presentation are confusing patients. This allows them to have more meaningful in-person conversations and perhaps even make future edits to parts that are consistently deemed unclear. In fact, all changes can be made more easily when using eConsent!
These changes include possible adaptations for:
- Language differences
- Vision impairment
- Other specific needs
With eConsent, you can change font sizes, switch out videos to more effectively engage a certain target demographic, and make countless other adjustments at the drop of a hat.
The Reason Behind Slow Adoption
With the numerous benefits, one would think all research sites would be in the process of making the worthwhile transition to eConsent. However, this is far from the case. Only 28% of global sites report using eConsent for at least one study, and a mere 2% use it across all studies.
But this wasn’t because they didn’t see the value in switching over. In fact, at least 50% of the 418 worldwide sites surveyed said that eConsent would decrease site burden and be easier to use. They agreed that this promising new technology would prove easier to use than paper consent because it:
- Facilitates more thorough patient comprehension.
- Offers improved version control
- Promotes a better dialog with the patients
So what’s the catch? If over 50% of clinical research professionals see the benefit in eConsent forms, are there any reasons why sites are still wary of taking the plunge?
It does takes an adjustment period to install and customize new technology, teach everyone how to use it, and grow completely accustomed to it. And of course the new purchase requires financial resources.
However, when asked directly, “Why have you not used eConsent on all clinical trials?”, the concerns were as follows:
- Less than 15% of sites expressed material concerns
- 12% said that their local ethics board or IRB did not approve
- 7% thought that it would be unacceptable to patients
- 6% thought the technology would be difficult to incorporate into their site workflow
As it turns out, time and money weren’t actually that major of a declared hindrance. So what concern accounts for the remaining majority of answers? The biggest reason why eConsent forms were not yet used for all clinical trials–coming it at a whopping 77%–was simply that the site hadn’t been asked by the study sponsor to do so.
That begs the question as to why more sponsors and CROs aren’t using eConsent? Perhaps they fear the sites won’t like it? Maybe they’re leery of introducing yet another system and system login?
As mentioned earlier, there is always an adjustment period when it comes to new technologies, but the rewards of eConsent with far outweigh the growing pains. In fact, it seems like just yesterday that EDC was the new scary thing that critics claimed would never work out. And now the majority of clinical research sites use it!
When it comes to improving your patient-centric strategy, you can take a significant step forward by investing in eConsent technology for your next clinical study. It helps patients and investigators make fully informed decisions, enables real-time tracking and data management, and streamlines a formerly burdensome process. This cutting edge technology will be a valuable asset to all, so let’s get proactive about using it!
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