It has been pointed out that there are more factors preventing the smooth operation of clinical trials for new drugs in the national hospitals and sanatoria compared with other medical institutions, In August 2000, the Ad Hoc Committee for the Promotion of Clinical Trials in the National Hospitals and Sanatoria was established, and the report of the Committee was published in June 2001. Following this, the new notifications to improve the systems for clinical trials which could be decided by hospitals themselves were set on November 2001, and they are promoting the clinical trials in the national hospitals and sanatoria. However, there are still many problems which can not be solved due to the relation of national accounting systems or which require the negotiation among tie sponsors and the government. It is important to found the systems of clinical trials not only for that of new drugs but also that in general.

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[in Japanese]

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It has been past for 4 years since the new GCP was implemented in 1998. During this period, so-called “hollow out phenomenon” has emerged and expanded as anticipated, resulting in the decrease of the number of clinical trials of newly developed drugs conducted domestically to one-third of that in 1993. The trials are initiated by companies, thus there are still many drugs that are used in Europe and U.S.A. as the standard but not authorized and applicable in Japan. To improve this situation, the Ministry of Health, Labor and Welfare is planning innovative approaches such as “Structural Establishment of Network for Clinical trials”, “Infrastructure Design for Guideline of Clinical Trials including Physician-initiated Clinical Trial”, and “Training for CRC” with the scope of law revision, We would like to consider several issues obtained from the recent 4 year experiences since we established the Clinical Trial Management Office in our hospital from the viewpoint other than the Goverment.

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We carried out a survey about the changes in clinical trial procedures among national hospitals and sanatoria induced by the notice from the Department Head of the National Hospitals. The summary of the survey indicates that the situations to perform clinical trials are getting better than before because of the preparation of clinical trial offices and clinical research coordinators. However, the restrictions caused by such as medical lows and national financial regulations are obstructing clinical trials from smooth operation, and both the government and pharmaceutical companies' joint efforts are necessary to solve these problems.

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Recently clinical trial offices have been established in the institution to support the clinical trials. At our institutions, the clinical trial office was established in 1999, and clinical research coordinators (CRCs) were managing all new clinical trials after the establishment of the office. We have evaluated our actual work and developed the systems of our office. Especially, we have made efforts to increase the number of CRCs, and to improve the education program for CRCs and the quality of our work. As a result, we have two and half times the number of CRCs compared with 1999, have developed a substantial education program for CRCs and the responsibility of the CRC was separated among the nurse and the pharmacist. Medical staff recognized the role of the CRC and the necessity of promoting clinical trials. To develop a system of clinical trials in the institution, it is essential that we place and educate CRCs, and develop a system appropriate for the specific clinical trials at each institution.

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Investigator-oriented clinical trials turn to be possible after the act which regulate pharmaceutical affairs have been changed in July 2002, Doctors need to perform clinical trials under the GCP regulation also in investigator-oriented clinical trials. In this article, the significance of the national hospital network for the investigator-oriented clinical trials are discussed. Infrastructures to conduct investigator-oriented clinical trials need to be prepared immediately.

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The Ad Hoc Committee for the Promotion of Clinical Trials in the National Hospitals and Sanatoria was established in August 2000 to launch the smooth promotion of clinical trials at these institutions, The Committee also has taken up the problems of clinical trials at national hospitals and sanatoria and tried to formulate solutions to them, In June 2001, the Committee released its first report. According to the report, the policy relating to the maintenance of the system for clinical trials of new drugs in medical institutions and the standardized forms for the Clinical Trial Contract were published in the form of notifications in November 2001. We report here on the basis of the results of a questionnaire survey of sponsors of clinical trials how the promotion of clinical trials at national hospitals and sanatoria was improved, what improvements were made, and what areas still require further improvement. The expectations and potential for the smooth promotion of clinical trials at national hospitals and sanatoria through several measures, including the construction of a system for clinical trials of new drugs via the network of national hospitals and sanatoria, are also discussed from the standpoint of the sponsor of a study based on the results of the survey.

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Although the national hospitals are highly active for clinical research and clinical trials and have 17 medical policy networks, there are several problems to be solved. Sponsors attach greatest importance to quick accumulation of the trial cases without GCP violation to any other points. The cost per an actually accumulated case and uncomplicated procedure of the contract are also important from the viewpoints of sponsors. The national hospital medical policy networks are expected to play a role in liaison activity of accumulating clinical trial cases with intractable diseases and investigator-initiated clinical trials. I hope that the report on promotion of clinical trial in the national hospitals in 2001 helped to improve the system, but problems regarding training and cost of clinical coordinator needs to be solved.

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In an attempt to improve the quality of nursing care in psychiatric wards, I conducted a survey distributing questionnaires to 109 nursing staff. In this study I tried to clarify how nurses think and feel about their own care for patients under physical restraint.
The results suggested: Nurses' awareness and feelings about physical restraint for psychiatric patients are ambivalent. Their feelings about physical restraint influence the quality of nursing care. Nurses and physicians should develop a system to be shared for the earlier patients' release from physical restraint.
Nurses should not be mechanical caregivers, but be aware of the significance of daily nursing practice and do professional decision making on behalf of patients.

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Clinical research could be generally defined as that researches benefit clinical routines. Department of clinical research should therefore be closely linked to the clinical facilities. Researches in National Hospital should be carried out using its broad networks under the guides of researchers belonging originally to the department of clinical research.
The first aim of this symposium was how we can solve our clinical problems through the clinical researches. Randomized control trials in the development of new drugs and clinical tests are promising methodologies in the networks of National Hospitals. Clinical researches that demand basic technologies and close collaborations with basic scientists could be executed on conditions that there are original researchers including MDs and PhDs with sufficient fiscal support. However, few departments of clinical research in National Hospital have sufficient infrastructures.
The another aim was how we should review clinical researches produced in the National Hospitals. The term of evidence-based medicine (EBM) with experimental methods (randomized control trials, RCTs) has been a gold standard in the world. Although there are four major limitations of randomized trials in the clinical researches as that experimentation may be unnecessary, inappropriate, impossible, inadequate, rational review of the researches in National Hospitals should be done in this context of EBM. The impact factors given to the official journals with peer review is a widely established method of reviewing, however, there are no consensus of the reviewing for the Japanese papers for which the chairpersons proceed to establish a review concept.

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