ACT: How can differences across therapeutic areas be used to create more standardized electronic clinical outcome assessment (eCOA) solutions?
Mooney: I think it all starts with, first of all as any eCOA vendor and here at IQVIA patient-centered Technologies we certainly acknowledge that there are those therapeutic areas that really do rely on clinical outcome assessments (COAs) to support main study objectives. So I think the first step for standardization within a therapeutic area is for eCOA vendors to be mindful and have a good understanding of that area’s landscape and we need to understand: are there existing clinical outcome assessment questionnaires that are available and consistently used as part of these COA strategies within that therapeutic area and oftentimes, if there are existing instruments or questionnaires, they do require a license and there’s a copyright holder or assessment distributor. So what we do is we try to collaborate with the owners to come up with a standard electronic version of the questionnaire so that the angle is as an eCOA provider, we have available in an eCOA library a standard version, electronic version of that questionnaire that we can use across studies so that we’re not recreating the wheel every time we have to implement that commonly used assessment within a study. So eCOA libraries and standardizing on the electronic version of clinical outcome assessments is key.
I also would say that if you look at a particular therapeutic area, the COA strategy itself tends to be similar across the protocols and that COA strategy usually impacts the data collection schedule so as eCOA providers, being able to understand that allows us to create standard reporting windows and reminder notifications that are really going to drive getting that data collected when it should be collected per the protocol standards. So I think those are the two key areas where we can standardize and create efficiencies for sponsors when we’re looking at a particular area.