Gaining patient consent is a key part of conducting clinical trials. This is an understatement since a clinical trial can’t proceed without it.
So, over the years a lot of effort was put into getting potential trial participants to sign densely worded pieces of paper that made sure, in theory, that they knew exactly what they were signing up for and what the possible risks might be.
More recently, the act of signing has started migrating to a tablet or computer screen. While this change has been hailed as a big advance for patient consent, when you look more closely, you might catch a glimpse of the emperor’s new clothes. Because, oftentimes, the only difference is that patients are forced to agree to something they don’t understand with an esignature instead of a pen.
Step away from the paper and look at the big picture.
One reason this shift in technology isn’t a true game-changer is that the limitations of traditional consent forms were only partly related to how they were delivered. It had much more to do with what they said (see “densely worded” above). The other important thing to keep in mind is that the consent form itself is only one component in a larger chain of events. Yes, patients are central, but there are crucial links to sponsors, Clinical Research Organizations (CROs), study sites and Institutional Review Boards (IRBs) as well.
In other words, it’s not just a piece of paper – it’s a process. One that ranges from defining parameters, to designing a form, to getting feedback, to making revisions, to getting sponsor and IRB approvals, to rolling it out to sites, to seeing how well it works in the field and sometimes back again.
The good news is that this new technology allows us to not simply translate something from paper to pixels but to rethink the entire process in a way that delivers benefits at every step.
This is what the future of eConsent might look like.
Admittedly, there’s a lot to think about — things like approvals, revisions, regulatory requirements, ease-of-use, protocol updates, technology integration and, of course, patient comprehension. If it feels too burdensome, the natural tendency is to not bother. So, cardinal rule #1 is that it can’t be more difficult to roll out an eConsent solution than it is to use existing, paper-based procedures.
Here are a few possibilities for improvements:
- Providing patients with clear, easy-to-follow information. Breaking pages of medical jargon into simpler language and smaller chunks is a good start. Serving up things like videos, voiceovers and visuals are even better.
- Making it straightforward for sites to deploy. You don’t want to make life difficult for the people on the front lines. The technology platform has to be both robust and easy to learn.
- Building IRB reviews into the system itself. Instead of sending an image of a form for approval, you can let the IRB log in and interact with the form itself — along with any videos, diagrams, comprehension cues or other explanatory content — just as a study subject would. This isn’t just a nice extra, but instead, we expect that this is what IRBs are going to be asking to see. Ideally, they’ll be able to make comments in the system as well.
Guess what? It can look like that right now.
You will not be surprised to learn that these ideas aren’t random, pie-in-the-sky ramblings. They’re at the heart of Bioclinica’s new eConsent solution, which integrates seamlessly with Bioclinica EDC.
Simply put, we looked at the entire process, thought of everything we could do to make it better and built a new solution that does all of it, fresh out-of-the-box, at a very low cost. It just works — without the expense of a big, bulk system or the pain of a steep learning curve.
We’ve even made it hassle-free to learn more: Click here.