2016 eCOA Industry Predictions: eCOA Innovations

December 3, 2015 Heather Bilinski

CRF Health's Rauha Tulkki-Wilke gives her perspective on eCOA Innovations in 2016

Q:  What do you feel is the next stage of eCOA innovation for 2016? 
Rauha Tulkki-Wilke: I think one of the more interesting things happening in the eCOA space is that we are seeing a lot more dedicated eCOA solutions being tailored or developed for the specific needs of different indications and different types of data being collected.  Previously, everyone basically used a very similar solution for a lot of different purposes. But now we are seeing companies, whether they are sponsors or vendors, really focused on what is needed for a specific indication, or what is needed by the patient population when certain types of data are collected. For example, consider concomitant medications, which are actually, from a patient’s perspective, relatively complicated if you want to collect them with as little burden as possible, and still collect really high quality data. Or, look at certain indications, like oncology or diabetes, or others where you collect episode-driven data. All of these can be quite complicated for patients or for site personnel.  Now the industry seems to be really paying attention to those unique needs and developing solutions that support the whole work flow - the whole journey through the trial.   The result will be something that is really unique and useful for specific studies. We are moving to more of a space where we have purpose-built solutions that truly cater to the varying needs of the specific segments of the industry. 

Q:  What are some of the key elements of purpose-built eCOA solutions versus standard eCOA solutions?
RTW:  Take a typical diary from two or three years back. A lot of the diaries then were built with just a button on the main screen saying, “Please fill in your diary today,” or something like that.  But now, especially when we collect a lot of data, for instance, in Diabetes solutions we collect meal and insulin dosage information and so on. We actually build it from the perspective that when the patient looks into the diary, they have a dashboard right there where they can see what they have done, what remains to be done, and what their current status is, and they can usually manage the data input or the data capture themselves. So we include solution specific dashboards, and in addition to those dashboards, we make it really easy for the patients to enter the data that they need to enter, so there’s as little burden as possible.  Even though it’s not really new, with therapeutic areas such as diabetes or asthma, and others, we can take data directly from medical devices, like physiological measurement data, along with the diary data.  We can do that in ways where it’s really straightforward for patients to take the measurements and enter the data at any point during the day, when it happens in their life.  We can limit the way we control or restrict patients in terms of when we expect those events to happen.  We want patients to enter the data as it happens during the day, as they live their lives.  That’s relatively complicated to design, and yet maintain really high data integrity and quality. But the whole point is that we make the diaries and the data collection fit into the patient’s life, instead of the patient living in a schedule designed by someone else. 

Q:  How will these innovations improve the patient and site experience? 
RTW: I think the main thing is actually that, in the end, they will improve site experience the most.  What we have seen for years in eCOA when we’ve been collecting data at home from patients, is that patients are actually pretty compliant. You really only end up having problems in areas where data collection is really burdensome. But when you encounter studies where patients actually do feel that the data entry is very burdensome, it’s the sites that are impacted the most, because they then end up having to support the patients and try to motivate them to do what’s required.  The sites are also quite busy, so they don’t really have time for that. So when you design a really good eCOA solution, of course it’s great for the patient, because they are able to use it better and in a more meaningful and relevant way.  But the impact accumulates at study sites.  If you’ve designed a really good solution, then it’s the sites that benefit from all of their patients being able to use it.

Rauha Tulkki-Wilke leads the development of new eCOA solutions and services at CRF Health.  Rauha has been with CRF Health since it was founded and has more than 13 years of experience with all that eCOA encompasses.

About the Author

Heather Bilinski

Associate Director of Marketing at CRF Health

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