Guest Column | September 26, 2011

ePRO And Parkinson's Disease Studies

By Kai Langel, Senior Director, Technical Support, CRF Health

CRF Health has been very active recently by doing some usability research on our own. We have conducted workshops with patient focus groups as well as usability research and testing with different devices and indications. One of the most interesting and challenging groups we have worked with are patients with Parkinson's Disease. We first did some PD studies a few years ago and got to understand some of the challenges these patients have to deal with as well as the research issues for clinical studies. The requirements for data collection in PD are the most demanding for the patients that I have seen in my 11 plus years of doing ePRO. This combined with the motor symptoms and the ON / OFF cycles the patients have to go through is not exactly an easy challenge for them. I took a bit of a personal interest to the matter after the FDA PRO guidance came out in 2009. I realized that paper data collection is no longer going to be a very reliable option for collecting this data and that efficient and easy-to-use solutions are needed. It wasn't very clear in the beginning what those solutions might be and it took some Sponsor input, creative thinking and significant advances in device usability to come up with a new kind of user interface to collect this data.

The end result is quite interesting. Where previously it took several ‘clicks' to enter symptom status data for a single 30-minute slot, the patients can now enter several time points at once, with just a single click each using a very visual and logical interface. There is minimal amount of text on the screen as the visual, iPhone-inspired icons are quite self-explanatory.