About the trial
In a Phase IIb study for a treatment for Chronic Venous Ulcer (CVU), FGK managed 44 sites in Germany for RHEACELL, a fully-integrated biopharmaceutical company that develops innovative stem cell therapies for severe immune and inflammation-driven diseases with high unmet medical need. In order to develop a cell therapy for the treatment of CVU, RHEACELL started a collaboration with FGK as a full-service CRO to conduct phase 1 to phase 3 clinical studies in patients with CVU. For this IIb study, 344 patients were screened and 159 enrolled within 38 months, with the help of a solid study team and an all-encompassing eCRF solution by Viedoc.
The study faced several challenges. The patient population had a very inconsistent wound care status, which resulted in a high drop-out rate during the screening phase. Therefore, a high number of screened patients was necessary to reach the recruitment goal.
“Given the timing (global pandemic) and rarity of our patient population, approximately 70% of screened patients did not meet the study requirements, so reaching the required number of patients was a significant challenge, not foreseen by the sponsor or investigators,” says Ursula Merz, Project Manager at FGK.
To address the recruitment difficulties, the close and fruitful cooperation with the sponsor and patient recruitment services helped bring in further patients across all participating sites. However, the main driving factor was the strong partnership between the project team and study sites. Through ongoing support by FGK, bureaucratic burdens were minimized and motivation remained high.