Successful Strategies to Recruit Patients with Familial Mediterranean Fever for a Multicenter Clinical Trial

Naoko HAGIMORI; Tomohiro KOGA; Sachiko TAKEMORI; Naoki HOSOGAYA; Chizu FUKUSHIMA; Hiroshi YAMAMOTO; Atsushi KAWAKAMI; the  FMF Project Team

doi:10.3999/jscpt.52.3

Original Article

Successful Strategies to Recruit Patients with Familial Mediterranean Fever for a Multicenter Clinical Trial

Naoko HAGIMORI, Tomohiro KOGA, Sachiko TAKEMORI, Naoki HOSOGAYA, Chizu FUKUSHIMA, Hiroshi YAMAMOTO, Atsushi KAWAKAMI, the FMF Project Team

Author information

Naoko HAGIMORI
Nagasaki University Hospital Clinical Research Center, Japan
Translational Research Center for Medical Innovation at Kobe, Japan
Tomohiro KOGA
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Japan
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Japan
Center for Bioinformatics and Molecular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Japan
Sachiko TAKEMORI
Nagasaki University Hospital Clinical Research Center, Japan
Naoki HOSOGAYA
Nagasaki University Hospital Clinical Research Center, Japan
Chizu FUKUSHIMA
Nagasaki University Hospital Clinical Research Center, Japan
Hiroshi YAMAMOTO
Nagasaki University Hospital Clinical Research Center, Japan
Atsushi KAWAKAMI
Translational Research Center for Medical Innovation at Kobe, Japan
the FMF Project Team

Keywords: investigator-initiated, multicenter, clinical trial, patient recruitment, rare disease

JOURNAL RESTRICTED ACCESS

2021 Volume 52 Issue 1 Pages 3-7

DOI https://doi.org/10.3999/jscpt.52.3

Details

Abstract

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.

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