薬理と治療

Abstract

Background　It is recommended to set up consultation services to properly conduct Chiken （clinical trials for marketing approval）and other clinical studies. One of the main tasks of the consultation services is to look for clinical studies（including Chiken）that can be participated at the request of patients. There are no reports investigating whether patients were actually able to participate in the clinical studies presented by the consulting services. Methods　Patients who were provided clinical studies information during the period from May 2019 to May 2020 at the clinical studies consultation service of Kyoto University Hospital were followed up for outcomes. Results　During the study period, there were a total of 48 requests for information on clinical studies, of which 35 were provided with information on clinical studies in which they could participate. Twelve patients responded to the follow‒up survey, but none of the patients were actually able to participate in the clinical studies for which information was provided. Discussion　Searching for clinical studies at the consultation service was based on the patient’s self‒reported medical histories and publicly available information on clinical studies, making it difficult to properly judge the eligibility for participation. In addition, there may have been cases in which participation was withheld due to the risk of experimental treatment. Conclusion　The provision of information about clinical studies did not lead to actual participation in clinical studies. The reasons for this were considered to be insufficient accuracy of information, patient anxiety about experimental treatments, and the availability of other options. The significance of providing information on clinical studies needs further investigation in the future.（Jpn Pharmacol Ther 2022；50 suppl 1：s16‒20）