A global biotech initiated a phase IIb orphan drug study for the treatment of chronic ulcerative colitis.
Study protocol originally accounted for randomizing 120 patients across 40 investigator sites in six EU countries. Full enrollment was expected after 14 months of campaigning.
However, after deploying traditional recruitment methods, the sponsor met only 60% of its patient enrollment target, and extended the recruitment window an additional six months.
This case study reviews how Trialbee partnered with the biotech to close the enrollment gap and move the study forward as planned.