The utilization of Real-World Data (RWD) derived from existing clinical data is gaining attention. In Japan, the “Rinchu-Net” project, launched in 2018, leverages existing clinical data from Clinical Research Core Hospitals. These hospitals have developed infrastructure for multi-center collaborative research using RWD from electronic medical records. With the revision of ethical guidelines for life sciences and medical research in 2021, the centralization of ethics reviews for each study was required. Many institutions had to adapt to new operational practices, presenting challenges in ensuring a unified review format and understanding cross-institutional data provision procedures. The Rinchu-Net project created standardized research protocol templates and operational guidelines to facilitate smooth research implementation. To smoothly operate the unified ethics review stipulated by the new ethical guidelines, it was necessary to overcome practical challenges such as managing research ethics across multiple institutions and data provision logistics. The project aims to leverage the knowledge gained through Rinchu-Net to promote the distribution of medical information throughout Japan, further vitalizing medical data flow within the country.

Objective　To find issues in Drug Use-Results Survey in Medical Institutions by assessing the views of physicians and pharmacists involved in Drug Use-Results Survey on their work and their acceptance of ethical considerations.

Methods　A questionnaire survey was conducted among physicians and pharmacists at 113 of the 140 facilities of the National Hospital Organisation, which had claimed the commissioned research funds in 2023.

Results　Responses were received from 104 physicians and 93 pharmacists. 76.0% of physicians and 62.4% of pharmacists stated that the task of preparing the survey forms was burdensome or somewhat burdensome. 74.0% of physicians and 78.5% of pharmacists answered ʻnecessary for all survey’ and ʻnecessary for some survey’ with regard to the need to written informed consent, while 21.2% of physicians and 8.6% of pharmacists answered ʻnot necessary’.

Conclusion　The study revealed that a high proportion of pharmacists, as well as physicians, felt that preparing survey forms was burdensome. In addition, while there was much support for the need for ethical review and obtaining informed consent from patients, several issues in the Drug Use-Results Survey were identified, such as differences in views on ethical considerations between physicians and pharmacists.

Background Decentralized Clinical Trials (DCTs) leverage digital technologies to conduct patient-centered clinical trials without requiring in-person visits. While DCT adoption is increasing globally, Japan faces challenges in its implementation. This study conducted a simulated fully decentralized clinical trial (full-DCT) to identify barriers and propose solutions for DCT adoption in Japan.

Methods We simulated a physician-led clinical trial for mild SARS-CoV-2 infection, evaluating the efficacy and safety of a hypothetical new drug. The study design included a double-blind, placebo-controlled, multicenter, randomized trial with 500 patients. The patients were screened and monitored via telemedicine, with trial drugs delivered directly to their homes. The study was conducted at three university hospitals with collaboration from each local partner medical institutions and home nursing services.

Results The simulated DCT was successfully implemented with few operational issues. Key findings included the necessity of streamlined communication between trial sites and each partner institutions, efficient drug delivery logistics, and enhanced digital literacy among healthcare providers and patients. While remote monitoring and electronic consent procedures functioned well, additional training and system integration were required for optimal execution. Challenges in regulatory compliance, data management, and participant engagement were also identified.

Conclusions The study demonstrated the feasibility of full-DCTs in Japan but highlighted critical challenges, including regulatory adaptation, digital infrastructure enhancement, and stakeholder education. Addressing these issues is essential for the broader adoption of DCTs, ensuring improved trial efficiency and patient accessibility.

Background Although the REDCap system is recommended for use at Osaka University, it had not been introduced in the Department of Psychiatry at the Faculty of Medicine.

Objectives The purpose of this study is to clarify researchers’ impressions and opinions during the implementation of the REDCap system, and to identify any changes over the time, in order to provide a foothold for efforts to improve the quality of clinical research data across the organization.

Methods A questionnaire survey was administered to researchers who had started using REDCap, assessing their knowledge and awareness of the system at three time points: before implementation, at the start of operation, and after a period of use.

Results The survey responses revealed that researchers’ use of the REDCap system increased over time and their attitudes toward it became more positive.

Conclusion By conducting a survey on researchers’ awareness of the REDCap system over time, we were able to clarify the process by which REDCap was introduced and its use expanded among researchers, even within departments where it was completely unknown.

Clinical trial operations involve many stakeholders and suffer from fragmented communication, accelerated timelines, and persistent information asymmetries with patients. This brief report proposes how extended reality (XR) and metaverse technologies could serve as a new communication layer for trials. We imagine a conceptual “dialogue space” in which clinical research associates and coordinators meet as avatars to exchange tacit know-how and protocol nuances with enhanced psychological safety-recreating the informal interactions lost during the COVID-19 era. We outline potential approaches, such as virtual patient advisory boards, expert-led education sessions delivered by avatars, and peer communities that may reduce anxiety, promote understanding, and support diversity in enrollment. We also consider potential operational and educational applications, including illustrative scenarios such as remote investigational medicinal product counting through XR headsets and exploratory preoperative VR training with patient-specific 3D models. The scenarios described are conceptual use cases rather than reports of implementation. Key challenges for any future deployment include data security and privacy, usability that allows intuitive use without special training, and legal/ethical frameworks for informed consent, data ownership, and incidental findings in virtual spaces. Developing practical guidelines and stepwise pilot projects will be essential to assess feasibility, validate utility, and surface risks prior to broader adoption.

In this research, we conducted a case study utilizing VR (Virtual Reality) and AR (Augmented Reality) technology with the aim of improving efficiency and digitalization of clinical trial monitoring process. We examined the verification process for remaining investigational drugs in remote communication between site staff and sponsor by using different device combinations. This case study showed that VR/MR technology enabled immersive remote monitoring, while we also found some technical challenges. This report explained the method, results, and future prospects of our exploration.

The Working Group 5 (WG5) of the Metaverse Medical Challenge (Me2C) is exploring the diverse applications of metaverse technologies in the field of clinical research. In response to the increasing importance of effective stakeholder communication following the COVID-19 pandemic, WG5 focused on facilitating interaction among clinical research coordinators (CRCs) using a metaverse platform. A pilot workshop was conducted targeting early-career CRCs. The event aimed to address professional concerns and improve peer support through anonymous interaction with experienced CRCs from other institutions. Pre- and post-event surveys revealed that participants found value in the opportunity to share concerns, gain practical insights, and feel a renewed motivation for their work. These findings suggest that anonymity in virtual environments can foster open dialogue and emotional safety, thereby enhancing peer learning and support within the clinical research community. Future workshops are planned, expanding on this initiative to further improve accessibility and engagement.

Background Although Clinical Data Interchange Standards Consortium (CDISC) standards are increasingly adopted in the pharmaceutical industry, where submission of compliant data is required for New Drug Applications, their adoption in academia remains limited because of the lack of regulatory requirements. Nevertheless, 53 self-motivated academic participants voluntarily gathered, demonstrating significant interest despite not having implemented the standards. This study aimed to identify barriers to adoption and explore what is needed to support CDISC implementation in academic settings.

Methods A questionnaire was distributed via Google Forms and sent via email to members who are currently contactable by the group leader. Responses were collected and analyzed using Gemma 2 to extract the key issues and propose solutions, with subsequent researchers reviewing the results.

Results Twenty-nine responses were obtained. Analysis identified three key challenges: (1) lack of knowledge regarding CDISC standards coupled with insufficient time for learning; (2) difficulty applying the standards in practice; and (3) limited access to expert guidance. Suggested measures include securing dedicated learning time, raising institutional awareness, developing stepwise educational materials, and establishing networks for collaboration and knowledge sharing.

Conclusions These findings validate previous observations regarding CDISC adoption challenges in academia. Importantly, these data-driven insights strengthen previously anecdotal understanding with evidence. New perspectives emerged, particularly regarding practical application difficulties and the critical role of expert interaction. Based on these findings, targeted educational resources and collaborative networks will likely promote the adoption of CDISC standards across academic research environments.