Status of Institutional Review Board Meetings Conducted Through Web Conference Systems in Japanese National University Hospitals During the COVID-19 Pandemic: Questionnaire Study.

BACKGROUND: With the global proliferation of the novel COVID-19 disease, conventionally conducting institutional review board (IRB) meetings has become a difficult task. Amid concerns about the suspension of drug development due to delays within IRBs, it has been suggested that IRB meetings should be temporarily conducted via the internet. OBJECTIVE: This study aimed to elucidate the current status of IRB meetings conducted through web conference systems. METHODS: A survey on conducting IRB meetings through web conference systems was administered to Japanese national university hospitals. Respondents were in charge of operating IRB offices at different universities. This study was not a randomized controlled trial. RESULTS: The survey was performed at 42 facilities between the end of May and early June, 2020, immediately after the state of emergency was lifted in Japan. The survey yielded a response rate of 74% (31/42). Additionally, while 68% (21/31) of facilities introduced web conference systems for IRB meetings, 13% (4/31) of the surveyed facilities postponed IRB meetings. Therefore, we conducted a further survey of 21 facilities that implemented web conference systems for IRB meetings. According to 71% (15/21) of the respondents, there was no financial burden for implementing these systems, as they were free of charge. In 90% (19/21) of the facilities, IRB meetings through web conference systems were already being conducted with personal electronic devices. Furthermore, in 48% (10/21) of facilities, a web conference system was used in conjunction with face-to-face meetings. CONCLUSIONS: Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% (15/21) of the respondents who conducted IRB meetings through web conference systems, the cost of introducing such meetings was US $0, showing a negligible financial burden. Moreover, it was shown that online deliberations could be carried out in the same manner as face-to-face meetings, as 86% (18/21) of facilities stated that the number of comments made by board members did not change. To improve the quality of IRB meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members' screens during meetings. Further examination of all members who use web conference systems is required. Our measures for addressing the requests and problems identified in our study could potentially be considered protocols for future IRB meetings, when the COVID-19 pandemic has passed and face-to-face meetings are possible again. This study also highlights the importance of developing web conference systems for IRB meetings to respond to future unforeseen pandemics.

Participant preferences for the provision of registration trials results.

BACKGROUND: Clinical trials leading to drug approval (registration trials) play a central role in the drug development process, and attention has recently been paid to providing trial results to participants. In the present study, we examined the preferences of participants of registration trials for the provision of trial-related information. METHODS: We used questionnaires to survey the preferences of registration trial participants at Tokushima University Hospital and Tokushima National Hospital. Of the 15 questions, 6 related to participant characteristics and the trials in which they participated, while 9 questions were concerned with preferences for the provision of information. A five-point scale (strongly agree, agree, neutral, disagree, and strongly disagree) was used, and positive answers (strongly agree and agree) were considered to indicate a positive preference. RESULTS: Of the 58 subjects, 1 declined, giving a response rate of 98%. More than 70% of participants preferred to obtain information, even if they had served as controls. More than 80% of participants agreed to obtain information relating to trial results, even if the results were negative, and more than 80% of participants agreed to obtain information on the labeling state of the agent, even if development had ceased. Although more than 60% of participants agreed for the provision of information on their allocation and around more than 70% agreed to the provision of information on registration trials status, significantly fewer participants with difficult-to-treat diseases (for example, neurological and malignant diseases) agreed to obtain information compared with participants with other types of diseases (for example, acute, chronic, and psychological diseases). More than 50% of participants desired information to be provided directly by the physician, while a considerable number of participants desired information by means of clinical research coordinators (CRCs) (24.4%) or by posted letter (33.3%). CONCLUSION: The present results suggest the preferences for the provision of individual and overall information concerning research results. However, further study is warranted to determine participant preferences more precisely and the effect of the CRC-initiated infrastructure for providing information on patient satisfaction and for promoting registration trials.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: Further study is warranted to evaluate the benefit of the intervention provided by dedicated CRCs in running high quality clinical trials involving surgical patients.

Clinical trials for drug approval: a pilot study of the view of doctors at Tokushima University Hospital.

The development of new and useful pharmaceutical drugs is essential in order to improve the quality of drug therapeutics. Clinical trials play a central role in drug development. Over time, the clinical trial infrastructure has improved and is now integrating the contribution of clinical research coordinators (CRC). Nevertheless, the attitude of doctors towards clinical trials still favors conventional/historical methodologies. In the present study, we explored the view of doctors towards clinical trials for drug development, in order to improve communication among participants, sponsors, and investigators.A questionnaire was designed for this pilot study. The questionnaire included general attitudes, difficult points, the benefit of doctors in participating as investigators, special attention requirements, and the expected role of CRC in clinical trials for drug approval. In addition, the appropriate use of the outpatient clinic was examined. The questionnaire was provided to doctors in each department of Tokushima University Hospital in 2000 and 2004. Because of the small number of subjects included in this pilot study, no statistical analysis is presented. A total of 89 (81%) and 62 (56%) doctors among 110 responded to the survey in 2000 and 2004, respectively. Inquiries about the familiarity of the physicians with clinical trials for drug approval revealed that 84% in 2000 and 66% in 2004 were aware of such trials. The attitude towards participating as investigators in the clinical trials was favorable, with a response of 66% in 2000 and 58% in 2004. Patients' refusal and the informed consent process were considered difficult areas by many doctors. Expected roles of CRC included activities based on the nurse's specialty. Although many doctors agreed to take care of the study participants separately from the clinical practice, they lacked the time to do so. In spite of the doctors' workload reduction by introduction of the CRC concept, their views regarding clinical trials for drug approval remain conventional. Further refinement in the support process by CRC should be considered in our hospital, and the views of the doctors should be investigated in a larger study, in order to promote clinical trials for drug approval in Japan.