Longitudinal, real-world data to support US FDA submission

A specialist pharmaceutical company commissioned us to recruit a group of people living with pouchitis, a rare gastrointestinal condition, and to track how it affects their lives over a six-month period. The objective was to generate real-world data to support a future regulatory submission to the US FDA, for approval of the company’s investigational drug.

We recruited 44 participants at baseline and retained 37 over the six months. We captured data on the impact of the condition on patients’ day-to-day lives (20 self-reported measures), including: their ability to work/study; physical and emotional aspects; and their relationships with others.

We concluded that a treatment that reduces pouchitis flares.