Annual Report 2023

Clinical Research Support Office

• Clinical Research Planning Division
• Clinical Research Management Division
• Seeds Development Promotion Division
• Clinical Research Coordinating Division

Introduction

 The Clinical Research Support Office supports the clinical trial program conducted in the National Cancer Center Hospital East (NCCHE).

 The Clinical Research Coordinating Division consists of Clinical Research Coordinating Section, Clinical Trials Administration Section, and Clinical Study Support Section.

The Team and What We Do

• Clinical Research Planning Division
• Clinical Research Management Division

 Through the clinical datacenter, study management, site visit monitoring, safety information, and medical writing.

• Seeds Development Promotion Division

 Promote seeds development though program management and start-up support.

• Clinical Research Coordinating Division

 The Clinical Research Coordinating Division is in charge of supporting clinical research and trials conducted at the hospital, including company- and investigator-initiated clinical trials, post-marketing, and expanded clinical trials, in compliance with the Clinical Research Act and guidelines, etc. The Clinical Trials Administration Section is in charge of administrative procedures including contracts for clinical trials conducted at the hospital. The Clinical Research Coordinating Section and the Clinical Study Support Section are in charge of subject management (patient interviews, assistance with study explanations, schedule management, observation of adverse events, etc.), data collection management (filling out case report forms), monitoring and auditing, transfer of some research samples, assistance with comprehensive consent explanations to first-time patients at the biobank counter, and support for biobanks that use surplus specimens, etc.

Table 1. Status of Clinical Trials


Table 1. Status of Clinical Trials


Table 2. Status of New Clinical Trials


Table 2. Status of New Clinical Trials


Table 3. Support for Clinical Trials in Compliancewith the Clinical Research Act and Medical System Guidelines


Table 3. Support for Clinical Trials in Compliancewith the Clinical Research Act and Medical System Guidelines


Research Activities

• Started 3 IND trials.
• Supported 6 start-up teams.
• Examined the usefulness of EDC data linkage systems and electronic data in clinical trials.
• Examined the risks in the protocol development stage.
• Performed benchmark-based costing of clinical trials in corporate clinical trials.
• Conducted human resource development for clinical research support, etc.

Education

 An educational program for new hires, and a training program for rotators are being implemented in accordance with the human resource development rotation. Feedback is provided on the level of proficiency and understanding based on three-monthly evaluations, and a training program for mid-career clinical research coordinators is under construction to help them advance their careers. For CRCs outside the hospital, facility tours and training for advanced-level CRCs were conducted. Regarding work-related risks and problems, cases and corrective actions are shared at regular meetings.

Future Prospects

 Major changes have been ongoing in the modalities of anticancer drugs, and the procedures and toxicities to be considered are changing accordingly. To support drug discovery and early development in Japan, we will continue to provide high-quality support while changing the conventional wisdom. At the same time, we will educate and train the next generation of human resources to support this. In addition, as the clinical trial environment has earnestly begun to incorporate digital technology, we will work to create a system that takes patient convenience into consideration while paying attention to safety, and to improve the efficiency of the work of CRCs and other supporting personnel.