Post-Study Survey for PK Studies in Patients with Hepatic Function Impairment in Japan

[Speaker] Mihoko Masuda:1
[Co-author] Megumi Inoue:1, Tomomi Hirota:1, Yumi Yamamoto:1, Rei Hayashi:1, Kumi Yamaguchi:1, Motoki Ishibashi:1, Masanari Shiramoto:1
1:SOUSEIKAI PS Clinic, Japan

Objectives: Evaluation of the effects of hepatic impairment for investigational drug PK is critical when considering a drug's efficacy and safety as to when the drug is administering to the patients. As these PK studies become more common, we performed a survey for the patients who completed the study to understand their opinion and experience as an attempt to conduct the future studies more efficiently and safely.
Methods: The volunteer surveys include questions pertaining each step of the PK studies with impaired hepatic function patients were performed after the completion of each study at our clinical trial center. For this study, a total of 14 patients (male:8, Female:6) with mild to moderate hepatic impairments answered the survey. The survey was approved by SOUSEIKAI Hakata Clinic IRB.
Results: Even though 9 out of 14 patients had never heard about clinical trials before, 9 patients said that they decided to participate in the study the day they heard about it from their doctors. Also, for the reasons to have participated in these studies, 11 patients answered that because their doctors explained and recommended the study to them. Regarding their stay in our center and the study procedures that they went through, most of them answered that they were satisfied with their experiences and no patient chose not to be participating in future study. The post-study survey shows that the relationship between patients and their primary doctors is critical when the patients decide participate in studies despite of no direct health benefits for them in Japan.
Conclusion: PK studies in patients with impaired hepatic function were often conducted at general hospitals in Japan. However, recently more studies are being conducted at specialized early-stage clinical trial centers as these studies often require more intensive attention, specialists on site, experience, and study management speed that an early-stage clinical trial site is equipped to handle. For successful PK studies with impaired hepatic function patients, it is important to have close connections with the subjects' primary doctors as well as to make clinical trial experience as comfortable and safe as possible by providing professional and careful considerations.

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