One of the largest sources of delay in clinical trials is difficulty to recruit. Once you obtain a subject, it's important that they remain engaged for the duration of the trial. Paper data collection makes this difficult.
Watch this short video to hear subject matter expert, Jery Grupp, reveal how sites can better retain their subjects and keep them more compliant with electronic Clinical Outcome Assessments (eCOA).
Certainly, an important topic in clinical trials is patient recruitment and retention. An eDiary solution has a great attribute differentiating it from a paper diary. One of those attributes is the ability for a site to remain in contact with their subjects to make sure that their behaviour is in compliance with the protocol. So, if a subject is supposed to be taking medication on a regular basis, and they’re completing a medication diary as they take the medication, if the site notices that they’re not recording their entries, they can make a proactive call to that subject to say, we noticed that you didn’t do your entries for the past two days, are you all right, is there something that’s preventing you from taking it, or did you just forget to enter. It shows that that subject is an important contributor to the trial. Paper, you don’t have that.
We have to remember that one of the single largest sources of delay in a trial is difficulty to recruit. So, once you get that subject, you want to make sure they remain engaged for as long as the trial requires them to be engaged. So, whatever you can do—be in contact with them, giving them positive feedback for their actions, whatever it takes to keep them compliant with the protocol, is going to be valuable.
We recently did an analysis—a post study, some work about what did sites think made their subjects most compliant. And it was interesting to pick up on the cultural differences. In some cultures, they actually found that the most valuable way of keeping a subject engaged was to have the site contact them proactively and compliment them on what they’ve done well. Others thought that the use of our alarm and our SMS messaging really made the difference for making the subjects remain compliant and engaged with the trial. And in that way, eCOA provides resources, or eDiary provides a resource for that. Because it keeps the site connected with the subject and knowing what they’re doing without having to pester them or remind them unnecessarily
That information, being able to look at it and determine, is the subject compliant, are they entering the data at the right time, is the data of good quality, all of these things are tools that are important and are part of our offering.
About the Author
Jackie Brusch is the Content Marketing Manager at CRF Health.More Content by Jackie Brusch