Limited or no availability of the Reference Listed Drug (RLD) for a generic dermatology trial can seriously hinder the feasibility of a study. This was exactly the case in a pivotal, clinical endpoint bioequivalence study for new generic compound to treat Scabies. The approved protocol determined that 140 patients were needed in the per protocol population to prove bioequivalence between the Sponsor’s drug and the RLD. The number of doses of RLD required to treat the population randomized to the Reference arm far exceeded the number available for procurement. Study abandonment was looming on the horizon.
Read how Biorasi solved the problem by using an innovative approach including the enrollment of patients with very high potential of protocol adherence and effective patient engagement to minimize the rate of retreatment throughout the study resulted in a successful study.