トクシマ ダイガク ニオケル コウド イリョウ ノ シエン キバン セイビ

Establishment of new modality of treatment, diagnosis and prevention of various diseases is an important role of university hospital. In this article, restrictions and guidelines for clinical investigations in Japan are reviewed and supporting system for promotion of clinical trials, now being organized at Tokushima University Hospital, is introduced. The main division in the supporting system of clinical trials is the Clinical Trial Center for Developmental Therapeutics. It was first organized as the Clinical Trial Center for New Drugs and Therapeutic in 1999 under the leadership of Prof. Saburo Sone. Five nurses work as clinical research coordinator (CRC) and coordinates close communication among participants, sponsor and investigators, and plays a crucial role in the efficient progress of clinical trials. Pharmacists and officers also contribute for promotion of clinical trials in the center. The supporting field is now being expanded from the support for clinical trial for drug approval to clinical trials conducted by investigators. For example, one pharmacist supports technically the project of dendritic cell-based vaccination against various malignancies in newly-constructed room. Based on the experience, our task is to grow the center to academic research organization. We are now dealing the following issues ; 1) promotion of clinical trials conducted by investigators, 2) scientific clinical trials of food, 3) setup of network of clinical trials in Tokushima prefecture with general physicians and other institutions

View of physicians on and barriers to patient enrollment in a multicenter clinical trial: experience in a Japanese rural area

<p>Abstract</p> <p>Background</p> <p>Clinical trials in the general practice setting are important for providing evidence on the effectiveness and safety of different agents under various conditions. In conducting these trials, the participation of physicians and patient recruitment are important issues. Various investigations in the literature have reported views and attitudes of physicians on various types of clinical trials. Nevertheless, there is still little information concerning physicians participating in a clinical trial and among them, those who could not recruit any patients (unsuccessful physician recruiters).</p> <p>Methods</p> <p>In 2003, we collaborated in a large-scale multicenter study of Japanese hypertensive patients (COPE Trial). In Tokushima University Hospital and 18 other medical institutions, we investigated the views and attitudes of unsuccessful physician recruiters in comparison with successful physician recruiters, using a questionnaire.</p> <p>Results</p> <p>The questionnaire was provided by mail to 47 physicians and 27 (57%) responded. The response rate was 79% for successful physician recruiters compared to 43% (P = 0.014) for unsuccessful physician recruiters. More successful physician recruiters (73%) than unsuccessful physician recruiters (42%) stated they had participated and enrolled patients in previous multicenter clinical trials. A significantly higher number of successful physician recruiters than unsuccessful physician recruiters (42%; P = 0.040) considered the presence of a support system with clinical research coordinators (CRC) as the reason for participation (80%). A large number of unsuccessful physician recruiters experienced difficulty in obtaining informed consent (67%), whereas a significantly smaller number of successful physician recruiters experienced such difficulty (20%; P = 0.014). The difficulties experienced by unsuccessful physician recruiters in the trial were as follows: inability to find possible participants (100%), difficulty in obtaining informed consent (58%), cumbersome procedures (58%), difficulty in long-term follow up (33%), and insufficient tools for explanation and obtaining informed consent (8%).</p> <p>Conclusion</p> <p>This survey showed that successful physician recruiters consider a support system with CRC of value, and that they are skillful in obtaining informed consent. These views and attitudes may have originated from past experience involving clinical trials. In this regard, we need to develop an infrastructure to enlighten physicians on this support system for the promotion of clinical trials.</p

Research ethics committees in Japan : A perspective from thirty years of experience at Tokushima University

The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions

Nurse awareness of clinical research : a survey in a Japanese University Hospital

Background: Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research. Methods: As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed. Results: Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse. Conclusions: These findings suggest that clinical nurses have only limited knowledge on clinical research and the importance to have chances to make nurses aware of clinical research-related issues is suggested to establish an extended research team. Because of the study limitations, further study is warranted to determine the role of clinical nurses in establishing a suitable infrastructure for ethical pursuit of clinical research

Perspectives of non-specialists on the potential to serve as ethics committee members

Objective: In Japan, under the new Clinical Trials Act pertaining to investigator-initiated clinical trials that came into effect on 1 April 2018, review boards should review proposed clinical trials while considering written opinions from specialists. Additionally, involvement of non-specialists is mandatory, and attention is being placed on their effective contributions. This study was performed to determine representative key issues with which to promote these contributions. Methods: This qualitative study was conducted in 2018 using a focus group interview of six non-specialists regarding perspectives on clinical research itself and research ethics committees. Results: For perspectives on clinical research itself, 33 codes were established and sorted into 2 categories and 6 subcategories relating to ambivalence toward clinical research. For perspectives on research ethics committees, 54 codes were established and sorted into 3 categories and 10 subcategories relating to the theme “knowledge and an environment that promotes non-specialist members’ participation.” One notable result was the willingness of participants to obtain details about a study should they be selected. Conclusions: The results suggest that detailed explanation of a particular study would encourage non-specialist members to participate in a clinical research review committee. Education aimed at non-specialist participation should therefore be considered in future studies

Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients

<p>Abstract</p> <p>Background</p> <p>Clinical trials play a central role in the establishment of clinical evidence, and the important role of clinical research coordinators (CRCs) in various processes of clinical trials is now widely recognized. In Japan, many CRCs work under the discretion of their hospital and support clinical trials in various areas. Modification of CRC activity pursuant to the types of clinical trials may make roles of the CRC more effective and meaningful. In the present study, we examine the dedicated role of the CRC considering the specialty of a registration trial of a drug for surgical patients used during the operation period.</p> <p>Methods</p> <p>In 2006, we had a chance to support a registration trial of a drug for surgical patients used during the operation period. Regarding the mental and emotional status of possible participants in the present registration trial, we collected data from the perspective of CRCs by focus group interviews involving four CRCs working under the discretion of Tokushima University Hospital. The four CRCs were all nurses and had 7, 4.5, 1, or 0.5 years experience as CRCs, respectively.</p> <p>Results</p> <p>In contrast to clinical trials of drugs for chronic diseases, these often anxious patients must decide whether or not to enter the trial simultaneously with the decision to undergo surgery itself, and all in a relatively limited time after receiving explanation of the trial. Therefore, special attention should be paid to the mental and emotional status of possible participants. Additionally, the cooperation of the relatively large surgical and nursing staff becomes important. In such situations, the following contributions of CRCs were considered to be useful for the harmonious procedure of clinical trials: 1) providing a precise explanation of the trial to the participant and key persons, 2) understanding the needs of the investigators and appropriately assigning themselves roles, and 3) communicating between the investigators and surgical and nursing staff.</p> <p>Conclusion</p> <p>Further study is warranted to evaluate the benefit of the intervention provided by dedicated CRCs in running high quality clinical trials involving surgical patients.</p

Serious adverse events and compensation in registration trials : a review of data from a Japanese university hospital

Background: Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis. Results: Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01). Conclusions: The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC’s ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials

Research ethics consultation : an attempt and 5-year experience in a Japanese University Hospital

Objective: Research ethics consultation is an advisory activity that differs from ethics committees, and its role is not yet widely known in Japan. Research ethics consultations were started in 2012 by members of the Clinical Trial Center of Tokushima University Hospital, a support section for clinical trials. We analyzed the research ethics consultation records from Tokushima University Hospital during the 5-year period of 2012–2016 to examine the Japanese context of research ethics consultation. Results: During the study period, 125 research ethics consultations were carried out, 115 (91%) before starting studies. All but one request were from investigators at Tokushima University. The main issue was compatibility with guidance and regulations (n = 74, 67.2%), such as ethical handling of human biological specimens and information utilized in research; only 6 (4.8%) requests involved research ethics issues that investigators face in their research. Therefore, it is necessary to expand the consultation function, with a nationwide system of consultant education and data sharing. Moreover, standardization of consultation should be considered

Present status of Japanese ethics committees : a survey in Tokushima Prefecture

Clinical research is important to improve medical quality, and ethics review is essential to conduct clinical research. Since the establishment of the first Japanese ethics committee at the University of Tokushima in 1982, Japanese ethics committees have increased. In this study, we surveyed the status of clinical studies and ethics committees in one Japanese region. The survey was conducted in collaboration with the Tokushima Medical Association. A questionnaire was established and mailed to all medical institutions (n=737) registered to the Tokushima Medical Association in 2012. Among 737, 223 (30.3%) questionnaires were returned and 221 were completed and are included in this analysis (respondents). Among respondents, 51 (23.1%) had performed clinical research, and of these, 17 had established ethics committees (though one was omitted from the following analysis due to an unsatisfactory response). Among 16 ethics committees, review of protocol amendments, review of serious adverse events, annual follow-up of approved protocols, and education for committee members were active in 10 (62.5%), 9 (56.3%), 6 (37.5%) and 4 (25.0%), respectively. Research ethics education was active in 4 (25.0%). Based on the results, we attempt to establish an appropriate system for ethical conduct of health-related research in Tokushima Prefecture