JGOG (Japan Gynecologic Oncology Group) is one of the most comprehensive research networks dealing with gynecologic malignancies, with broad experience of clinical trials (both domestic and international). In 2021, JGOG founded EAGOT (East Asian Gynecologic Oncology Trial Group) with 3 other Asian clinical trial groups; KGOG (Korean Gynecologic Oncology Group) from South Korea, CGCS (Chinese Gynecologic Cancer Society) from China, and TGOG (Taiwanese Gynecologic Oncology Group) from Taiwan. An ARO network, to which the principal investigators in each clinical trial belong, has been constructed by domestic institutions. Results: Various types of investigator-initiated phase 2/3 trials involving JGOG in collaboration with KGOG are currently under preparation in EAGOT with universal protocols, an ICH-GCP based ARO data center, and CDISC standards. Our randomized phase 3 trials aim to establish standardized treatment guidelines, including adjuvant chemotherapy versus concurrent chemoradiotherapy, for postoperative cervical cancer, as well as adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery. Investigator-initiated phase 2 clinical trials focus on taking forward unapproved drugs such as PARP inhibitors and immune checkpoint inhibitors for future approval. Development of international registry systems and translational research with virtual slides, AI deep-learning studies and multi-omics analyses are also in progress. Cooperation of JGOG/EAGOT with the ARO network can provide a core global research network for bigdata clinical trials in Asia. We believe this approach will contribute to expansion of various types of nationwide “diseasespecific” consortia into global clinical trial networks.

In Japan, two types of glucagon products, which contain recombinant glucagon or synthetic glucagon as an active ingredient, have been approved and marketed. On June 7th, 2021, the Glucagon (Genetical Recombination) monograph was newly listed in the eighteenth edition of the Japanese Pharmacopoeia (JP). In the monograph, peptide mapping with α-chymotrypsin was set as the identification test; however, the specification of theα-chymotrypsin reagent is unclear because there is no information about the substrate used in the activity assay, the definition of the enzyme unit or the purity. Therefore, selecting anα-chymotrypsin reagent can be an issue when performing the identification test. In this study, we measured the chymotrypsin activity and residual trypsin activity of severalα-chymotrypsins, including the United States Pharmacopeia and the European Pharmacopoeia chymotrypsin reference standards and commercially availableα-chymotrypsin reagents, and conducted an identification test according to the JP glucagon monograph; theseα-chymotrypsins were used to evaluate the effect of differences in the activity of the chymotrypsin and residual trypsin on the test results. As a result, it was found that the current specification for chymotryptic activity of the JPα-chymotrypsin reagent may be higher than necessary to obtain the intended peptide map, and slight tryptic activity is required to generate the reference peptide peaks. Based on these findings, we discuss the appropriate specification of the JPα-chymotrypsin reagent.