This study analyzed clinical trial information for small- and medium-molecule drugs approved for pediatric indications in Japan between 2012 and 2021, aiming to elucidate the implementation status and characteristics of pediatric clinical trials, and participation of Japanese pediatric patients. We examined publicly available data from the Pharmaceuticals and Medical Devices Agency website for drugs approved for pediatric indications. The study excluded biopharmaceuticals and public knowledge-based applications. The analysis focused on the status of clinical trial implementation, trial design characteristics, and Japanese pediatric participation. Of 97 products analyzed in this study, 89 (91.8%) received approval based on pediatric clinical trial data. Of 274 clinical trials submitted for evaluation, 173 trials (63.1%) were pediatric trials, 119 (43.4%) of which included Japanese pediatric participants. Early-phase clinical trials accounted for 34.1% of foreign clinical trials, but only 13.8% of domestic trials, with no stand-alone phase I trials conducted in Japan. Implementation rates of randomization and blinding were lower in domestic trials (27.5% and 24.8%, respectively) compared to foreign trials (46.3% and 36.6%). Analysis of Japanese pediatric enrollment showed low participation, with a median of 5.5 Japanese patients enrolled in multi-regional clinical trials and 6 in rare disease trials. Age group analysis revealed that while 86 trials enrolled young children aged 1 to<7 years and 108 trials included children aged 7 to<15 years, only 1 trial enrolled neonates (birth to<4 weeks) and 33 trials included infants (4 weeks to<1 year). The present analysis revealed structural and operational challenges in Japanese pediatric drug development, including limited early-phase trials, underuse of rigorous study designs, and insufficient trials involving younger age groups. Contributing factors may include a shortage of specialized personnel and procedural barriers. While extrapolation using foreign and adult data has supported pediatric drug approvals, early discussion of pediatric development plan for integration into the adult development program─in line with recent regulatory guidance─is essential to generate evidence optimized for Japanese pediatric populations.

Electronic consent (eConsent) has garnered increasing global attention as a crucial method for facilitating decentralized clinical trials (DCTs). However, its adoption remains limited in studies in small-scale institutions or those with personnel and budgetary constraints. In a prospective observational study aimed at improving the diagnostic accuracy in differentiating bipolar disorder from depression, we introduced eConsent and successfully obtained over 500 completed remote informed consent forms within a small-scale operational framework. This paper reports on the practical implementation of this approach. The study was coordinated by a three-member team consisting of a principal investigator, a departmental clerk, and a project manager. A dedicated website was developed to recruit participants, and explanatory materials such as a written document and a 12-minute video were provided. Informed consent was obtained using a cloud-based platform, and participant identity was verified remotely via Zoom. Pre-prepared email templates were used to streamline communication with participants.

Of the 646 individuals who expressed interest in participating, 505 ultimately provided informed consent. The use of standardized email templates facilitated efficient and consistent handling of over 80% of correspondence. Although 16% of consent forms contained input errors, these were resolved with prompt email follow-up. The combined use of digital tools and explanatory videos enhanced participant comprehension and reduced administrative burden on the study team.

This study indicates that large-scale remote informed consent can be achieved even within a small-scale operational framework and offers a practical model for future eConsent implementation in decentralized clinical trials, particularly in resource-limited research environments.

Since June 2023, I have been engaged in research at the Meakins-Christie Laboratories, located within the McGill University Health Centre in Montreal, Canada, under the supervision of Professor Martin. My work has focused on investigating immune responses using a murine model of irritant-induced asthma. In this study, we elucidated IL-33-induced polarization of pulmonary macrophages and reported the involvement of M2 macrophages in addition to the IL-33/ILC2 axis. We are also currently analyzing the adaptive mechanisms of immune responses following repeated exposure to chlorine gas. Furthermore, I have been involved in clinical research examining sputum cellularity and immune biomarkers during acute exacerbations of asthma. I am deeply grateful for these valuable experiences and the generous support I have received.

Venous thromboembolism (VTE) is a common complication occurring in patients with cancer, significantly affecting prognosis. Although the efficacy of direct oral anticoagulants, including edoxaban, for treating cancer-associated VTE has been demonstrated, Japanese patients often experience bleeding when administered standard doses. Conversely, dose reduction may compromise the efficacy, making dose adjustment challenging. We prospectively analyzed the relationship between edoxaban plasma trough concentrations and bleeding events or therapeutic efficacy in cancer patients with VTE. We included cancer patients diagnosed with VTE and treated with edoxaban at the Shiga University of Medical Science Hospital and Kyoto University Hospital between April 2022 and December 2024. Edoxaban concentrations were measured using liquid chromatography-tandem mass spectrometry. Major bleeding and clinically relevant non-major bleeding (CRNMB) were assessed using ISTH criteria. Efficacy was evaluated using an imaging-based assessment of the thrombus size. Eleven patients (median age: 72 years) were included; nine patients received 60 mg/day, and two received 30 mg/day. Cancer types included lung (three patients), uterine (two patients), ovarian, bladder, gastric, pancreatic, intrahepatic cholangiocarcinoma, and melanoma (one patient each). Five patients had metastatic disease, and nine received chemotherapy. The VTE types included pulmonary embolism (eight patients) and deep vein thrombosis (six patients), with overlap in three cases. Median trough edoxaban concentrations were higher in patients with major bleeding than those without (32.6 vs. 13.5 ng/mL, P = 0.200). Among the seven patients assessed for efficacy, the concentration was 50.3 ng/mL in the case with no change in thrombus (one patient), 29.7 ng/mL in the case with thrombus improvement (one patient), and a median of 13.4 ng/mL (range: 9.3-223.7 ng/mL) in cases with thrombus disappeared (five patients). The measurement of edoxaban concentrations may help predict major bleeding in cancer patients with VTE. However, owing to the small sample size and preliminary nature of this study, further investigation is warranted.