What if electronic Clinical Outcome Assessments (eCOA) offered advanced functionalities AND it was a less expensive option than paper COA?
In this 3-minute video, Jery Grupp, Director of Client Relations at CRF Health with 20 years of experience, discusses some of the hidden costs of paper and added benefits of eCOA. Don't miss this opportunity to learn how you can have enhanced, more successful trials.
Sometimes people look at eCOA and paper and their first impression is that paper comes with no expense. Yeah, they acknowledge that there’s minor expense for printing it and maybe for distributing it. But they’re missing a lot of the other expenses that are administrative expenses in terms of getting the data off the paper and into a database. There’s data entry, there’s verification, there’s site monitoring visits to ensure the data is there, data clarification forms if there’s been errors made in the data.
Many of those expenses are either eliminated or greatly reduced when you go with eCOA. So, the real task is to look at each trial individually and make an assessment of, is it appropriate for an eCOA solution.
You may see savings where the eCOA costs you one-third of what the cost was of a traditional trial done by paper. But it’s not only about that hard dollar costing. Sometimes there are quality measures, or efficiency measures, that you want to be able to use, that certainly outweigh even an extra cost.
The ability to monitor and provide oversight to subjects is an important weight that may not be seen as a dollar value or dollar savings, but certainly getting accurate data is the goal of any trial. So, if a subject were coming in on a visit, a four-week visit schedule, and you didn't have that data for four weeks, when they came in you have no way of knowing was that data true, accurate, and entered in a correct way at the time. With an eCOA solution, particularly one from our company, with CRF Health, our systems report back the data each night automatically without the user’s intervention, to our Trial Manager centralized app. The sponsor, the sites, can run reports to look at that data and make sure it’s coming in in a timely manner, that they’ve got compliant reports. And then the other key that happens in that mix is our ability to notify the subjects or to notify the sites to notify the subjects.
There was an old story we used to joke about, that people getting out of the car at the physician's office when arriving to meet with their investigator, would take longer to complete their diary while sitting in the car.
Once you hand the subject the diary and say please complete the diary, if you don’t see them again for four weeks and they come in, you don’t know if they’ve completed it at all until they walk in the door. You can’t make the corrective actions.
That’s certainly not the goal, and that’s where eCOA makes a big difference. It’s contemporaneous. It’s recorded with the metadata about what time it was recorded. And because of Part 11 compliance, it also records who completed it.
And so, when the question is, is it cheaper, sometimes the criteria isn’t the cost, the out of pocket hard money cost. It’s that improved quality, that improved oversight and the ability to prove that, as a person conducting or an organization conducting a clinical trial, that you’re in control at all times. That has value that sometimes far exceeds the cost benefit, the actual dollar cost benefit.