Although pediatric drugs are essential in treating children with severe diseases, there is a notable delay and absence of their clinical development in Japan; consequently, acceleration of the pediatric drug development process is an urgent issue. To reveal the underlying causes of this inadequacy of pediatric drug development in Japan, we conducted a questionnaire survey involving physicians, clinical research coordinators, and others involved in pediatric clinical trials at medical institutions. The lack of profitability for companies, small number of pediatric patients, and difficulty in conducting pediatric clinical trials are the dominated responses of the reasons for hesitating drug development for pediatric oncology and rare intractable diseases, with response rates of 72.3％ (180/249), 56.6％ (141/249), and 53.0％ (132/249) for pediatric oncology, and 77.5％ (193/249), 63.1％ (157/249), and 45.4％ (113/249) for pediatric rare and refractory diseases, respectively. The lack of knowledge and experience on the part of medical institutions is the dominant reason for the difficulty of study implementation, with 83.1％ (123/148 patients) for pediatric cancer and 86.6％ (110/127 patients) for rare intractable diseases. 83.5％ (208/249) of the respondents were in favor of encouraging multinational trials, respectively. Clinical trials need to be concentrated in base hospitals to improve knowledge and experience regarding multinational trial. As suggestions for other measures, some respondents mentioned incentives for companies, while others mentioned making pediatric clinical study obligatory. Obligatory and incentives need to be considered together. On the contrary, only 63.9％ (159/249) of the respondents were positive about strengthening patient-requested therapy system (“Kanja moushide ryoyo”).

Although studies in the 2000s examined clinical trial education and awareness surveys among medical and pharmaceutical students, current trends remain unclear. At our university, fourth-year students are educated about the significance of clinical trials and research in the clinical pharmacology and therapeutics lectures. Surveys are conducted post-lecture to gauge students' comprehension and intentions for future participation. This study analyzed medical students' understanding and future participation intentions in clinical trials and research. In 2022 and 2023, we analyzed responses from 207 out of 234 students using artificial intelligence-enabled text mining and quantitative analysis to reduce researcher bias. Students emphasized the importance of clinical trials for benefiting future patients, developing new treatments, and reciprocating past benefits. 68.1％ expressed interest in future participation, while 17.4％ were indifferent, and 14.5％ preferred not to participate. Reasons for students' decisions included contributing to patients, advancing medical/healthcare, personal interest, career planning, clinical inclinations, and suitability for researchers. Key reasons for participation included helping patients (65.2％), advancing healthcare (53.3％), and personal interest (34.0％). Correspondence analysis revealed links between career planning and neutrality, and between suitability for researchers and lack of interest. Students who were not interested or indifferent expressed concerns, such as a preference to work as a clinical physician, lack of vision regarding a career path as a clinical researcher, worries about the responsibility and low success rates of clinical trials, and delayed outcomes. Some students might not grasp that clinical research is an extension of medical practice before clinical clerkship, possibly influencing their choices against participation.