2021 年 52 巻 1 号 p. 3-7
We conducted an investigator-initiated multicenter clinical trial targeting patients suffering from Familial Mediterranean Fever (FMF). Due to the rarity of the disease, the absolute number of candidates in Japan was considerably small (500 at most). We proceeded with subject recruitment and implemented methods to achieve the target study sample. Our operations team promoted patient recruitment by employing multiple strategies throughout the patient recruitment period. We achieved 95% of the target study sample of 23 patients. Fifty patients gave informed consent to participate in the trial. We found that the flexibility according to the situation is an important and necessary element for successful recruitment.