Utilizing COAs Across Different Therapeutic Areas

ACT: How does the utilization of clinical outcome assessments (COAs) differ across the various therapeutic areas?

Mooney: That's a great question. I would say, in general, clinical outcome assessments can benefit just about every therapeutic area in some way. However, we certainly see that there are some therapeutic areas that definitely rely more heavily on the utilization of COAs, and COA strategy to support their protocols, key study objectives, and endpoints. And these are usually therapeutic areas where the disease is known to have a really profound impact on the patient's daily life; how they they're able to go about their daily activities, engage in social situations, and just their overall general well-being is often impacted by the disease. So it makes sense and these types of protocols that the key study objectives and endpoints are usually crafted around how a study treatment impacts the various facets of that patient's life. So we find in these therapeutic areas, that there usually exists a vast number of clinical outcome assessment questionnaires that are intended to measure how that specific disease is impacting the patient's life. So usually in those protocols, COAs are front and center.

To summarize, I would say the utilization of COAs across the therapeutic area or how it differs is really dependent on how that therapeutic area’s protocols use COA strategies to drive their endpoints and objectives. And the utilization tends to be higher in those therapeutic areas where COAs are supporting objectives that are higher in the objective and endpoint hierarchy I'll say.

I can expand on that a little bit more as far as areas where we see a high utilization of COAs, dermatology studies, for example, clearly people who have skin conditions, it's impacting their outward physical appearance often and that takes its toll psychologically, and then, of course that impacts the patient's ability to go about their daily life. So in dermatology studies, we definitely see COAs being front and center and used in abundance in those areas. Same with pain studies. Any area where being able to measure improvements is difficult to do objectively and you really need the voice of the patient. That's also where we see COAs playing a really important role.