TrialMax® eCOA Solution for Asthma Clinical Trials

November 30, 2015

Full Transcript

Katie Garner, Therapeutic Areas Advisor

I think that asthma clinical trials have adopted electronic methods of collecting data much more easily than other therapeutic areas, because of the specific challenges that are facing asthma, like the sheer amount of data that needs to be collected, the patient population is involved in capturing that data. And the physiological measurements as well. It’s quite a natural fit for an intuitive, electronic system that takes the patient through the journey.

There are challenges in collecting, PEF data and all the data that’s collected in asthma trials, like the awakenings the symptoms. The challenges in collecting that on paper include: the patient actually remembering what symptoms they’ve had, and the patient remembering to fill in the data in the first place.

Relying on paper means that there’s room and there’s risk for error and information not being accurate. Patients might realize suddenly that they’ve forgotten to fill something in, and then they can’t quite remember, so they think—write down something that sounds about right. But with an electronic system, the patient is reminded and they’re doing it there and then, and it’s much more accurate and much more complete.

CRF Health’s solution for asthma involves an integration to a PEF meter, which means that the PEF meter data is automatically downloaded into the daily diary.

The main benefit of having integration from the PEF meter to the eDiary is—is that it makes the process of transferring data seamless. The patient doesn’t have to do it themselves, they don’t have to write a number down, or remember it, or write it in a different log. It’s all in the same place and it—it’s all done for them. And that really reduces any risk of transcription errors.

When the patient blows into that PEF meter, the readings are automatically transferred onto their daily diaries, so the patient doesn’t have to do anything, it’s quite seamless, it’s very easy to use, and it’s one less thing for the patient to think about. It really reduces the burden on them.

We have Trial Manager, which helps the sites to manage the amount of data that’s—that’s coming in, with reports and notifications. And then we also have, on our electronic system, we can notify and remind the patients that they need to collect data or, there are pop-ups which will tell the patient that they need to contact the site.

With CRF Health’s site management portal, sites can access all of our information, and they can access it in a really easy to digest format. We can generate reports which will show which patients have had exacerbations, and which patients are experiencing an increase in symptoms or an increased use of rescue medications. So they can be individual reports, but we can also set up emails to go to sites, or SMS messages, to flag up patients that are—that are having problems. And that really helps the site to manage their situation, which is really, you know, data overload.

There are huge benefits to using electronic. Most of them are around compliance and capturing more complete and more accurate data and more timely data. The sites can see what data’s coming in and make sure it’s coming in, and then they can act on that data. Make sure that the patient’s being treated appropriately. And generally, it makes—makes the trial much better. 

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