Recently, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) proposed the draft guidance “ICH‒E11A Pediatric Extrapolation”, drawing attention to methods for obtaining pediatric indications based on drug characteristics. In this research, we investigated the trends of development of pediatric medicines in Japan, focusing on the utilization of pharmacokinetic information. Drugs with a pediatric indication approved between 2012 and 2021 were included in the research. Biologicals, antineoplastics, topical agents, and diagnostics were excluded. Following the establishment of the Review Committee on Unapproved or Off-Label Drugs with High Medical Needs in Japan in 2010, the number of drugs approved via public knowledge-based applications was the highest in 2012 followed by a trend of decrease except in 2018. In contrast, the number of multi-regional clinical trials involving pediatric populations showed an upward trend. The drugs with population pharmacokinetic (PPK) analysis evaluated for pediatric indication were characterized by high bioavailability, low protein binding, and high contribution of renal excretion. These results indicate the necessity for strategic approaches including early integration of pediatric populations in multi-regional clinical trials for drugs with potential pediatric indication. The pharmacokinetic characteristics of the drugs evaluated by PPK analysis resembled those of drugs that are less sensitive to ethnic differences as outlined in ICH‒E5 (R1).

Objective: Follow-up by pharmacy pharmacists plays a crucial role in managing treatment schedules and reducing adverse events associated with cancer chemotherapy. In light of this, we developed the capecitabine module of “FollowNavi^®”, a LINE-based follow-up support system designed for medication guidance. Our objective was to assess the system's effectiveness in reducing the severity of capecitabine therapy-induced hand-foot syndrome and improving medication adherence.

Methods: A six-month follow-up was conducted using “FollowNavi^®” among patients prescribed capecitabine between February 2021 and January 2022. The study's primary endpoint was the incidence of hand-foot syndrome throughout the follow-up period. A survey was also conducted with patients and pharmacists to gather feedback on using “FollowNavi^®”.

Results: Eight patients were included in the follow-up, and hand-foot syndrome was observed in 62.5％ of cases (CTCAE Grade 2 or PRO-CTCAE Moderate: 12.5％). The time required for each “FollowNavi^®” session ranged from less than 5 minutes to 10 minutes. Furthermore, 66.7％ of patients expressed their desire to continue using “FollowNavi^®” after the completion of the study.

Conclusion: Continuous follow-up with “FollowNavi^®” demonstrated a potential reduction in the severity of hand-foot syndrome among patients undergoing capecitabine treatment. Additionally, a questionnaire survey was conducted among patients and pharmacists revealed positive responses regarding the system's usability.

Pharmaceutical companies are not necessarily willing to develop drugs for children, and consequently, conducting investigator-initiated clinical trials (ICTs) is essential for pediatric drug development in Japan. Since ICTs were introduced in 2003, there have been efforts to decrease the burden on clinical trial sites, but there are apparently still problems and hurdles. We have conducted a survey about these issues and possible solutions targeting those with experience regarding ICTs in children. A web-based questionnaire was sent to physicians, clinical research coordinators, and other staff involved with ICTs. The results of the questionnaire revealed several problems and hurdles, including protocol design, invasive or inappropriate laboratory testing procedures, limited blood sampling volume, lack of reference values for laboratory data, inappropriate dosage forms, and insufficient research funding. We examined the background and causes of the problems, reviewed the published papers, sought opinions from experts, and proposed solutions in this paper.

In December 2019, a pneumonia epidemic was first reported in Wuhan, China. Soon after, its causal virus, a novel coronavirus or SARS‒CoV‒2, spread worldwide. The WHO officially declared the global COVID‒19 pandemic on March 11, 2020. Due to the pandemic and related increased medical treatment needs, not only the treatment for COVID‒19 but also for other diseases was brought into crisis, collapsing the overall medical system and causing devastating effects on people's health worldwide. Accordingly, the development of vaccines against SARS‒CoV‒2 became imperative.

While the EU and the US have actively promoted their vaccination policies, Japan has fallen behind due to pre-COVID accidents caused by vaccines, and lawsuits over inoculation. Thus it was thought there would be challenges regarding the conduction of new vaccine trials in Japan. Below is a list of some of the challenges we faced during our COVID‒19 vaccine studies:

 ・Substantial time was needed to conduct ascending dose studies in which the safety in a low dose group must be confirmed before proceeding with a high dose group;

 ・Due to accelerated public vaccinations, the recruitment of treatment-naïve subjects became increasingly diffi cult;

 ・In some cases, subjects who had previously participated in a vaccine trial and received a study vaccine were not allowed to receive public vaccinations because the influence of the study vaccine on the safety and efficacy of approved vaccines was unknown.

As vaccinations have been recommended and new mutant strains reported, close attention to the development trends of new vaccines against the novel coronavirus variants remain important.

Medication management and guidance are among the most important elements in preventing cardiovascular diseases during cardiac rehabilitation. In the field of cardiology, where patients tend to take multiple medications as they age, a collaborative relationship with community pharmacies is indispensable. In particular, there is significant diversity among physicians and facilities regarding the administration of medications for heart failure. This diversity presents a major barrier to providing drug administration guidance at community pharmacies. As a solution to this problem, a new form of collaboration between physicians and community pharmacies using SNS (Slack) could be an excellent opportunity. Physicians could use SNS to share their treatment policies and drug selection criteria with the dispensing side. On the pharmacy side, this would enable them to share, in advance, the rationale behind drug selection by physicians and their intent to reduce or increase the number of drugs. This approach will contribute to improving the accuracy of explanations and guidance for patients. The remarkable development of information transmission technologies, such as online communication and wearable devices, will not only aid in sharing digital information but also in building human connections and communities.

Current clinical research is required to plan and pursue in accordance with the following three laws: “GCP Ordinance,” “Clinical Trials Act,” and “Ethical Guidelines for Medical and Health Research Involving Human Subjects.” However, it is not easy to understand these laws and regulations completely while managing a busy clinical practice. For this reason, many studies have recently focused on methods to explain, such as classification of each point of laws related to clinical research. It is expected that enough comprehension by simplifying and visualizing law and regulations related clinical research. In the field of law informatics, the use of natural language processing to analyze legal texts and visualize the structure of consisting words lead to the effects such as understanding the relation between laws and reducing management cost. The aim of this study is to visualize the ministerial ordinances, laws, and guidelines related to clinical research. In this paper, the purpose is capturing the outline of laws and regulations related clinical research by visualizing the relation of words constituting letter of law by use of co-occurrence network. The word combinations with particularly strong co-occurrence and common words for several laws were obtained, furthermore the words were focused that common words are co-occurring. As a result, it was predicted at the word level that, the important words for each law, and how are the common words used in, in each law. The evaluation accuracy improvement is expected by applying these relations to evaluation of similarity between laws. Furthermore, by using the visualization results, it is expected the possibility of understanding these laws and regulations related to clinical research from a different perspective until now.