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Core Hospital for Clinical Study

Okayama University Hospital Playing a Central Role in International Standard Clinical Study

Okayama University Hospital was selected as a “Core Hospital for Clinical Study” in April 2013.

With the aim of creating innovative drugs and medical devices in Japan, the “Core Hospitals for Clinical Study” play central roles in international standard clinical research, investigator-initiated clinical trials for intractable diseases, and post-market clinical research. Okayama University Hospital brings together numerous affiliated hospitals in a consortium, forms networks by diseases such as intractable diseases, rare diseases, and childhood diseases, and plays a central role in research support which would be difficult to implement other than in investigator-initiated clinical trials or in international standard clinical studies (conforming to ICH-GCP).

CONSTRUCTION OF THE NEW PARADIGM

The history of Okayama University Hospital has proceeded forward from the foundation of Okayama Domain Igakukan (Medical School) in 1870 (Meiji 3). During that time, we and our predecessors have continued to construct new paradigms through challenges posed by advanced medical care and human resource development.

ARTFUL

Realization has been achieved of innovative medical care, including the world’s first “living donor transplant of the middle lobe of a lung” and Japan’s first “simultaneous liver and kidney transplantation from a living (brain-dead) donor,” based on sophisticated technology and research accumulated through its long history.

ADVANCED

Production continues of world first medical technologies that no others have achieved, by connecting “sophisticated technology,” such as a cancer therapeutic gene “REIC,” which has been undergoing clinical trials, and “the improvement of pediatric cardiac function with regenerative medicine,” “innovative facility environments,” and “excellent human resources” with high dimensionality.

HEARTFUL

Medical environments are amenable to patients as well as to medical care professionals in both “soft” and “hard” aspects, such as the IVR Center, 20 operation rooms, including a hybrid operation room, the construction of a bio bank system, with the top class number of doctors and nurses in Japan.

Okayama University Hospital Direction of the Core Hospital for Clinical Study

In the project of the Core Hospital for Clinical Study in FY 2013, Okayama University Hospital established a firm foundation to become financially self-sufficient. To this end, along with the promotion of clinical research itself, efforts at open innovation and area management are indispensable.

One of the largest scale clinical research networks in Japan
83 facilities (33,000 beds) in hospitals with more than 200 beds

OPEN INNOVATION

Open Innovation for the Formation of Medical Industry Cluster

We formed the “Mid-Western Japan Clinical Study Consortium” with 83 facilities (about 33,000 beds) in hospitals with more than 200 beds in cooperation with affiliated hospitals in the Chugoku?Shikoku area. Constructing a huge network in the Chugoku?Shikoku area facilitates our ability to meet requests for clinical trials and large scale clinical studies from pharmaceutical companies. By facilitating those processes, we promote open innovations looking at a “way out,” forming of medical industry clusters, and achieving regional industrial development.

MANAGEMENT

Raising the Level of the Chugoku?Shikoku Area as a Whole

We held the Liaison Committee of the Chugoku?Shikoku area National University Hospital Clinical Research Promotion Council and liaison meetings in the Mid-West Japan Clinical Study Consortium, shared information about efforts towards the development of clinical research, and hosted public symposia. As preparation for pharmaceutical applications, we actively develop human resources who are able to assume quality-assured clinical research through the improvement of educational programs provided by people who experienced the PMDA review and by those who completed the FDA training, e-learning, and OJT.

Examples of Measures from 2013

Thorough search for seeds through touring of hospitals ● Steadily picking up seeds of promise, face-to-face

In the search for promising seeds of the network, we have been visiting network hospitals in sequence since 2013, initiated by the “Center for Innovative Clinical Medicine” in Okayama University Hospital. Through conducting interviews in a slow but steady manner, we have seamlessly and strategically promoted the research and development of seeds for drug exploration, clinical research based on doctors’ individual initiatives, and further sponsor-initiated clinical trials that aims at the approval of new drugs and medical devices.

Establishment of the Foundation for Information Sharing ● Introducing expansive and expandable systems

It will further engender clinical research based on free thinking and the development of new drugs and medical devices if we can share these newly discovered promising seeds widely in the entire network. Foreseeing the medium-term to long-term expansivity and expandability, we launched the improvement of database management fitting to ICH-GCP compliant clinical trials, including the introduction of cloud-type case collection systems and the expansion of the use of the systems that have already been used to collect data by patients.

Support for Multi-center Clinical Research ● Creating a uniform standard operating procedure

To support clinical research in which multiple hospitals cooperate, we created a uniform standard operating procedure to guarantee the ethical and the scientific validity. Additionally, we strengthened the ethical review system and established the Clinical Research Review Expert Committee as IRB, and the Clinical Trial Review Committee. Furthermore, we are striving to improve our efficient and high-quality ethical review system, including actively appointing External Review Committee members and making e-learning compulsory for the Review Committee members.

Consortium Liaison Meeting ● September 27, 2013

The liaison meeting of the Mid-Western Japan Clinical Study Consortium was held. The approximately 50 participants included people from consortium participant hospitals and people in charge of practical business affairs. All enthusiastically offered their questions and opinions about the promotion of clinical research.

Kickoff Symposium ● October 5, 2013

The Kickoff Symposium of the Core Hospital for Clinical Research was held, in which about 170 researchers and people from pharmaceutical companies participated. We hosted panel discussions by representatives from national university hospitals in the Chugoku?Shikoku area.

Clinical Research Promotion Council ● November 28, 2013

We held the Chugoku?Shikoku area Liaison Committee for the First National University Hospital Clinical Research Promotion Council and shared information about each university’s efforts at the promotion of clinical research and associated problems.