October 9, 2020
Yuko Kitagawa, Hospital Director, Keio University Hospital
Masayuki Amagai, Dean, Keio University School of Medicine
In the following investigator-initiated clinical trial conducted at our hospital, there was a delay in reporting that did not comply with the provisions of the "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (PMD Act), its Ordinance for Enforcement (Ordinance for Enforcement of the PMD Act), and the "Ministerial Ordinance on Good Clinical Practice for Regenerative Medical Products" (GCP Ordinance for Regenerative Medical Products).
Clinical Trial Title: A Phase I Clinical Trial of RK-163-pulsed Human Autologous CD14-positive Cells (RK-CD14MO) for Patients with Advanced/Recurrent Solid Tumors
Start Date: March 12, 2018
Termination Date: April 24, 2020
Clinical Trial Registration Information: UMIN000031684 (UMIN Trial ID)
The specific details of the non-compliance are as follows: In July 2019, the coordinating investigator and the principal investigator at our hospital received a report from the provider of the investigational product stating that the investigational product administered to one subject in February and March of the same year was out-of-specification (filled with a number of cells exceeding the pre-determined upper limit). Despite receiving this report, they failed to recognize this information as requiring mandatory reporting under the PMD Act, the Ordinance for Enforcement of the PMD Act, and the GCP Ordinance for Regenerative Medical Products. Consequently, they neglected to promptly notify the hospital director, the Institutional Review Board, and the principal investigators at other clinical trial sites, and also failed to report to the Minister of Health, Labour and Welfare within the prescribed period.
We hereby announce that, regarding this non-compliance, our hospital has investigated the root causes and considered preventive measures based on our internal investigation and the opinions of our hospital's Audit Committee for Specified Clinical Research, which convened on August 4, 2020. A report was submitted to the Ministry of Health, Labour and Welfare on October 2, 2020.
No serious adverse events or health damage were observed in the subject who received the out-of-specification investigational product, and we provided an explanation of the circumstances and an apology in March 2020. Furthermore, no similar out-of-specification issues occurred with the investigational products used for other subjects. A notification of termination for this clinical trial was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) on April 24, 2020.
We take this situation very seriously and are fully committed to implementing thorough preventive measures to ensure that investigator-initiated clinical trials are conducted properly, in compliance with applicable regulations, and with the utmost priority on protecting the rights and safety of trial subjects.
We sincerely apologize to all the patients who participated as subjects in this clinical trial, as well as to all related parties, for the concern and inconvenience this matter has caused.
For inquiries regarding this announcement:
General Affairs Office (Nagatsuma, Yokota), Keio University Shinanomachi Campus
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL: 03-5363-3611 (Weekdays 9:00 a.m. – 5:00 p.m.)
Email: med-koho@adst.keio.ac.jp
http://www.med.keio.ac.jp