Center for Research Administration and Support (CRAS)

Teruhiko Yoshida, Nobuko Ushirozawa, Satoshi Takeuchi, Yoshimitu Sakamoto, Kiyokazu Kawashima, Shugo Nemoto, Ayako Mesawa, Yuichi Amanuma, Fumie Suzuki, Kiyoka Nagayama, Yuko Yamada, Miki Ito, Sawako Nakayama, Emi Nobuhara, Chinatu Watanabe, Genta Ohno, Yukari Nakayama, Ryota Kosaka, Junko Kaneko, Kazunori Aoki, Kazuhiko Aoyagi, Kazuya Tuchihara, Noriko Yamashita, Yayoi Ofuji, Kuniko Takahashi, Norie Enomoto, Yoko Yokota, Satoko Arai, Emi Kunimatsu, Keiko Koide, Sanae Kawada, Masami Sekine, Megumi Teshirogi, Masahiko Ozaki, Yuki Harada, Takahiro Sakai, Hayato Kamata, Kaori Yanagisawa, Sayaka Yamamoto, Yoko Matsubuchi, Miwa Kanehira, Taro SHIBATA, Aya KUCHIBA, Junki MIZUSAWA, Masashi WAKABAYASHI, Gakuto OGAWA, Ryunosuke MACHIDA, Ryo SADACHI, Ryo KITABAYASHI, Yuki KONDA, Naomi KONISHI, Kohei UEMURA, Akihiro HIRAKAWA, Shogo NOMURA, Masayuki YOKOYAMA, Riku KAJIKAWA, Seiichiro YAMAMOTO, Suga YAMAGAMI, Masashi MIKAMI, Shintaro IWAMOTO, Ryo KANZAKA, Tsunakuni Ikka, Haruka Nakada, Saito Yoko, Tomoko Seki

Introduction

 The Center for Research Administration and Support (CRAS) was established on July 16, 2014. The starting members of the CRAS were approximately 160 staff, who together provided diverse functions and specialties, ranging from research fund administration, alliances with the private sector, intellectual properties, clinical research coordinations and data management, monitoring and audit, biostatistics support, secretariat services for research ethics (IRB), and COI committees.

 The background and purpose of the creation of the CRAS was explained by Dr. Tomomitsu Hotta, the President of the National Cancer Center (NCC), in NCC News 2014 Vol. 5 No. 3 (in Japanese). Briefly, since its foundation in 1962, the NCC has added several new segments and organizations to evolve as a comprehensive cancer center. Because each segment needed its own research infrastructure, support activities in the NCC had become fragmented and scattered with the possibility of gaps and redundancies. Dr. Hotta approached the Strategic Planning Bureau and assembled the “NCC New Vision” in FY 2014, in which he proposed integration and communication for various research support functions in the NCC. The CRAS was created in response to the FY 2014 Vision.

 In FY 2015, the NCC Hospital (NCCH) and the NCC Hospital East (NCCHE) were certified as Core Clinical Research Hospitals under the Medical Care Act in August and September, respectively. As a result, the governance of the Research Coordination Division, Research Promotion Division and Regulatory Science Section of the CRAS moved to the Clinical Research Support Offices, which belong to the common departments of each hospital. In January 2017, these divisions and section were officially separated from the CRAS in the NCC organization.

 Another major reformation of the CRAS in FY 2017 was the establishment of the Bioethics Division by expanding the former Bioethics Section. The Clinical Trials Act was promulgated on April 14, 2017 and came into effect on April 1, 2018. Despite the general scarcity of human resources in the specialty field, the NCC has been endowed with strong staff, who have been contributing to work not just inside the NCC but also all over Japan with regard to research ethics-related issues including the implementation of the Clinical Trial Act.

 In FY 2018, the concept of the RA (research administrator) system in the NCC was discussed in the CRAS and updated in the NCC headquarters.

 In FY 2019, under the leadership of the new Chief of Bioethics Division, several important discussions and pieces of rule-making were done in collaboration with the researchers and staff in both campuses of the NCC. For instance, liaison and research manager staff have been assigned in each section of the NCC to facilitate communication between researchers and the research ethics review committee and build a solid base for the research ethics in the research groups.

 In FY 2020, the CRAS continued to work in response to directions by the government on research governance, such as the establishment of a basic policy for the data sharing in collaboration with the JH (Japan Health Research Promotion Bureau), an organization officially established in FY 2020 to promote alliance among the 6 National Centers. The CRAS led the coordination of various sections on both campuses to get a more precise and comprehensive picture of the research-related funding and revenue of the NCC.

 In FY 2021, the CRAS has made several renovations to support the researchers, such as the introduction of electronic grant application systems, to alleviate their administrative burden in the research activities. Another revision of the CRAS organization scheme was moving the Human Research Protection Section from the Bioethics Division to the Research Administration Division, thereby demarcating the research review function and research support services such as research ethics consultation.

 In FY 2022, the CRAS has further evolved electronic grant application system to the integrated database of the public grants and the NCC Research & Development fund, so that the NCC can review and analyze its research portfolio and potentials. The total research funds awarded to the NCC researchers, both from public grants, contract and collaborative research and revenues from intellectual properties, have been increasing and reached over 20 billion yen. The remarkable performance of the NCC is of course attributable primarily to the high research capabilities and motivation of the NCC researchers, the role played by the Research Alliance and Intellectual Property Section has been also crucial, for its excellent strategic advice and support. Along with the avid collaboration with the industrial sectors, institutional COI policy has been drafted in FY 2022 by COI Management Section.

 (Future prospects)

 The NCC embarked on the new era under the leadership of a newly appointed President and Directors of the NCC Research Institute (NCCRI) and both hospitals (NCCH, NCCHE) on April 1, 2016. The Vision and high-priority research targets have been redefined, and re-organization remains in progress in various parts of the NCC. However, the core concept of the CRAS stays unchanged to contribute to the NCC mission by promoting organic unity of the NCC as a whole and the CRAS aims to contribute to bringing the various sections together in the NCC.

1. Research Administration Division

1)  Research Administration Section

 The Research Administration Section is a central office in charge of various administrative work related to research funding including application and reporting. The major external funding sources of the NCC are competitive grants from the government and government-supported agencies, such as the Ministry of Health, Labour and Welfare (MHLW), the Japan Society for the Promotion of Science (JSPS), and the Japan Agency for Medical Research and Development (AMED).

 This section also serves as an administrative office for the NCC Research and Development Fund, which is provided directly from the government to the NCC for fulfillment of its mission as the national core institute of cancer control. This section organized seminars regarding research funding and its rules to prevent financial misconduct or research misconduct.

 The Guidelines for Managing and Auditing Public Research Funds at Research Institutes were updated by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) in February 2021 and adopted by the MHLW in March 2021. This section serves as a compliance promotion office of the Guidelines and has established a new system for research fund administration, which is fully compatible with the new Guidelines.

 Based on revision by MEXT of the guidelines for managing and auditing public research funds at research institutions, we formulated an action plan to prevent the improper use of research funds. As part of our enlightenment activities, we distributed newsletters and disseminated items related to the prevention of improper use of research funds. (The items were reported by the compliance promotion officers of each department to each department’s members, in order to raise their awareness related to the prevention of financial misconduct.)

2)  Research Alliance and Intellectual Property Section

 We efficiently build bridges between NCC research and industries by collective management of the collaborative research alliance and the utilization of intellectual properties (IPs) arising therefrom.

1. Alliance with the private sector

 We have supported NCC's variety of alliances, including but not limited to establishing worldwide comprehensive collaborative partnerships with major pharmaceutical companies and academic institutions. Currently, 11 comprehensive collaborative alliances are active between NCC and domestic/overseas industry partners (Figure 1). We have been also supporting a nationwide genomic screening project (SCRUM-Japan “Cancer Genome Screening Project for Individualized Medicine in Japan”) led by the NCC as first challenge in Japan. Nationwide medical institutions and 21 domestic/overseas pharmaceutical companies have joined aforementioned Project (Table 1). The collaborative researches and research funds that we manage have been increasing year by year. In 2022, the number of collaboration cases reached 676, and the amount of research funds reached 4.70 billion Japanese yen (Figure 2).

2. Intellectual property management

 We encourage, needless to mention the collaborative research results with companies, NCC researchers to license-out IPs derived from their researches at early stages to partner companies who can work together towards realization of their research results. Our IP strategy enables us to reduce costs in patent prosecution and to expedite commercialization of our research results, eventually availing the receipt of monetary consideration. On the other hand, for those IPs NCC substantially bears the cost, we constantly review the value of IPs and dismiss those which could not find sponsors within a certain period. By allocating NCC’s financial resources to IPs with commercial values, NCC has been successful in sustaining positive outcome of IP management for years (Figure 3).

Figure 3. Intellectual Property Income

3. Certified ventures

 We certify “NCC-launched venture companies” that try to perform application and commercialization of IPs and research results originating in NCC. As of 2022, we have certified six NCC-launched venture companies (Table 2).

Table 2. Certified Ventures

Human resource development and education

 We host educational seminars of essential IP knowledge to NCC faculties at least twice a year. Our staff are encouraged to participate in seminars and conferences to update their knowledge on IP laws, regulations, and guidelines as well as scientific technologies, all of which are necessary to promote the academic-industrial alliances. From time to time, we consult with experts, such as lawyers and patent attorneys, to solve problems and to gain practical experiences.

Prospects

 Under the NCC’s vision of “commitment for providing the best possible cancer treatment and care through relentless partnership with the community”, we will keep supporting the creation of effective and innovative collaborative research frameworks which develop to fruitful research partnership. We will continue to play key roles in assisting the NCC making decisions on its IP management.

 In the future we will deepen our cooperation and knowledge-sharing with CPOT so as not to dissipate our knowledge and experience cultivated in the past 10 years due to turnover of well-experienced staff.

3)  Research administrators

 Research administrators (RA) has supported to translate research outcomes into practical application based upon a comprehensive alliance with pharmaceutical companies. As part of Tsukiji TR Board activity, RA has promoted cooperation with industries and academia through an information session and exhibit in BioJapan 2022 to introduce the bioresources, advanced technologies and recent research findings in the NCC. RA also supported the progress of AMED research projects through the Practical Research for Innovative Cancer Control Management Office (PRIMO), and collaborative research projects of 6 National Centers (NC) conducted by Japan Health Research Promotion Bureau (JH).

 (Future Prospects)

 RA promotes the translation of innovative research in the NCC to clinical diagnostic and therapeutic development and to patient care through several major mechanisms: Tsukiji TR Board, comprehensive alliances with leading companies, participation in the academic Drug Discovery Network, and cooperation between 6 NCs and JH.

4)  Human Research Protection Section

 The Human Research Protection Section (HRPS) serves as the administrative offices for the various types of IRBs for human subject research, including the certified review committees defined by the Clinical Trials Act (Act No. 16 of April 14, 2017).

 Accomplishments of the reviews by the IRBs at the NCC in FY2022 included 2,070 active research projects and 312 new research plans by the NCC faculty members (include 101 central reviews); while a total of 9 new research plans by researchers outside of the NCC were requested for review.

 (Future Prospects)

 The HRPS will continue working, in corporation with the NCCH’s and the NCCHE’s Ethical Review Support Sections, to ameliorate the NCC’s whole ethics review processes for more appropriate and efficient ways to be achieved. Partial revisions to the guidelines were announced on March 27, 2023 during this fiscal year, but guidance for the guidelines was not issued within the fiscal year, so it is scheduled to be implemented next fiscal year.

2.  Biostatistics Division

 Biostatistics Division has a role of responsibility in formulating research hypothesis, study design, analysis, interpretation and publication, especially in JCOG and EPOC clinical trials and the investigator-initiated clinical trials which are led by investigators in the NCC Hospitals. We have also committed to establish an infrastructure to support the clinical trials in the NCC Hospitals. Furthermore, we have been actively involved in collaborative relationships with the NCC Research Institute and the Institute of Cancer Control.

 Furthermore, we have provided biostatistical consultation and expertise, which supports NCC investigators working on basic, translational, clinical and epidemiological researches.  We offered advice to about 166 problems (78 in Tsukiji campus and 88 in Kashiwa campus) for which biostatistical consultation was requested from April 2022 to March 2023.

 A survey of biostatistical consultation provided in the NCC were presented as a poster at the 14th Annual Meeting of the Japan Society of Clinical Trials and Research. In addition, one statistical methodology research paper as the first author was accepted in the Clinical Trials, and oral presentations were given at the Annual Meeting of the Biometric Society of Japan and the Japanese Joint Statistical Meeting.

Education

 We provided 13 introductory Biostatistics lectures for investigators in NCC to learn and review the elementary aspect of Biostatistics. We had a cumulative total of 486 participants. In addition, we hosted a Biostatistics lecture to cover advanced and important biostatistical side of various application fields and a total of 62 investigators participated. The lectures are open to any applicants from outside institutes.

 In addition, we provided an internship program for 17 graduate students from the graduate schools of the University of Tokyo (the Biostatistics and bioinformatics course, Graduate School of Interdisciplinary Information Studies).

 In response to the activity of career development and education for biostatisticians by the Japan Health Research Promotion Bureau (JH), we have accepted one senior biostatistician from the National Center for Child Health and Development (NCCHD) on a weekly basis, in addition to participating in the newly established "Young Biostatisticians NC Collaboration Training Pilot Project" starting from fiscal year 2022. Through this initiative, we have admitted two junior biostatisticians, one from the National Center of Neurology and Psychiatry and one from the NCCHD, into on-the-job training (OJT) program on a weekly basis. Notably, one of these individuals obtained the accreditation of a Trial Statistician through the Biometric Society of Japan in fiscal year 2022, based on achievements that encompassed OJT experiences.

 In terms of educational outreach to clinical research practitioners nationwide, we have continued to develop and operate the e-learning platform ICRweb (Introduction to Clinical Research: https://www.icrweb.jp), releasing a total of 118 new contents. The user base has grown from 156,614 to 177,014, and we expanded to include 20 new facilities, bringing the total number of contracted institutions to 134. This expansion ensured stable operations independent of research funding. Graduation certificates were issued for 23,584 completions, representing the widespread provision of clinical research education to a diverse range of individuals engaged in clinical research.

 Furthermore, as part of the Asian Clinical Trials Network initiative (ATLAS Project) by the National Cancer Center Hospital, an English version of ICRweb was introduced, offering learning opportunities in clinical research in English to not only domestic but also international practitioners. Continuing from the previous year, we further enriched the 6NC Common Educational Platform with lectures not only on clinical research but also animal experimentation and data science, contributing to comprehensive education.

Future Prospects

 The NCC has a critical role for providing clinical service, education, conducting researches and making policy recommendation/proposal, which are all required to make a decision on the basis of solid and scientific evidence from reliable data and information. The mission of the Biostatistics Division is to contribute to the providing best evidence and the improvement of clinical practice and public health through the development and application of statistical methods. The Biostatistics Division is expanding on its independent and collaborative research with a range of areas, including prevention and policy recommendation/proposal, as well as treatment development. In addition, we have made a particularly effort to build effective relationships with the investigators at the NCC Research Institute and the Institute of Cancer Control. Collaborative projects have been launched, including the evaluation and implementation of medical technology with artificial intelligence, and one of them received approval under the Pharmaceutical and Medical Device Act. Collaboration on epidemiologic studies have motivated to develop statistical methods to get deeper insight of etiological mechanisms or public health impact. We are working on promoting cooperative framework with outside experts in statistics/biostatistics. We are opening up a new methodological research area in which a mathematical approach will serve as a solid basis.

3.  Bioethics Division

 The Bioethics Division provides education and training on issues related to research ethics and conflicts of interest (COI), mainly in relation to the protection of human subjects, including ethical guidelines for life sciences and medical research involving human subjects, the Pharmaceutical Machine Law, the Clinical Research Law, laws related to regenerative medicine and the Personal Information Protection Law, and the operation of various ethical review committees for human subject research. The following are some of the activities.

• The National Cancer Centre's "Training for new employees" (delivered online in April).

 Training on research ethics at the National Cancer Centre's 'Clinical Research Seminar' (1 June, 1 July, 6 July, 6 October and 21 January in FY2022).

• Training for Ethical Review Committee and Clinical Trial Review Committee members in 2020 (21 January 2023).

 In addition to the provision of these education and training programmes, the Bioethics and Medical Law Section and the COI Management Section, each of which is located in this division, carries out the following activities.

(1) Bioethics and Healthcare Law Section

 The Office of Bioethics and Medical Law provides research ethics consultation services to researchers, research assistants and research ethics review committee members at various stages from the planning of research to its publication. Unlike ethics review, research ethics consultation is non-binding advice and deals with ethical issues beyond regulatory compliance.

 FY2022 results: 153 consultations were received annually. 59 were from researchers and others at the Tsukiji Campus and 94 were from researchers and others at the Kashiwa Campus. 2 cases were related to the Clinical Research Act, 137 cases to ethical guidelines and 53 other cases.

 (Future Prospects)

 We will continue to provide and enhance our research ethics consultation services. In FY2023, the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects were revised, and we will strive to support the smooth implementation of research based on the new guidelines from an ethical perspective. Other research support activities related to the Centre as a whole, in addition to consultations with individual researchers, will be continued as necessary.

(2) COI Management Section

 Our section serves as the COI management committee secretariat to manage NCC researchers’ COI and to respond to inquiries. The subjects of COI management are physician-initiated clinical trials, some of the clinical research conducted under the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects. We recommend that the researchers who are involved in the research project funded by national ministries or authorities disclose their COI despite being subject to COI review. Furthermore, we manage the COI of the members of the research ethics committee and institutional review board. We also handle the COI management required by the Clinical Trials Act.

 FY2022 results. The COI management committee reviewed 121 physician-initiated clinical trials (2753 researchers) and 181 clinical research conducted under the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects (2123 researchers). We responded to 14 inquiries from researchers or staff. Our committee conducted COI reviews of 32 members of the research ethics committee, 27 members of the institutional review board, and 7 members of C-CAT Data Utilization Review Board. Furthermore, we verified 243 COI disclosure forms following the Clinical Trials Act. Furthermore, we completed the COI Declaration Management System modification to verify the researchers’ COI disclosure required by the Clinical Trials Act. We have almost completed the drafting of the institutional COI management policy.

 (Future Prospects)

 We continue to improve the structure of COI review and management. In FY 2023, we will finalize the institutional COI management policy and start to implement it. Also, we will continue to inform the researchers to use the COI Declaration Management System when they prepare the COI documents under the Clinical Trials Act.

List of papers published in 2022

Journal

1. Mizusawa J, Ohba A, Ozaka M, Katayama H, Okusaka T, Kobayashi S, Ikeda M, Terashima T, Sasahira N, Okano N, Miki I, Kaneko T, Mizuno N, Todaka A, Furukawa M, Kajiura S, Kataoka T, Fukuda H, Furuse J, Ueno M, Hepatobiliary and Pancreatic Oncology Group of Japan Clinical Oncology Group. Protocol of a randomized phase II/III study of gemcitabine plus nab-paclitaxel combination therapy versus modified FOLFIRINOX versus S-IROX for metastatic or recurrent pancreatic cancer: JCOG1611 (GENERATE). Japanese Journal of Clinical Oncology, 53:80-84, 2023

2. Nihei K, Minashi K, Yano T, Shimoda T, Fukuda H, Muto M. Final Analysis of Diagnostic Endoscopic Resection Followed by Selective Chemoradiotherapy for Stage I Esophageal Cancer: JCOG0508. Gastroenterology, 164:296-299.e2, 2023

3. Kadota T, Hasuike N, Ono H, Boku N, Mizusawa J, Oda I, Oyama T, Horiuchi Y, Hirasawa K, Yoshio T, Minashi K, Takizawa K, Nakamura K, Muto M. Clinical factors associated with noncurative endoscopic submucosal dissection for the expanded indication of intestinal-type early gastric cancer: Post hoc analysis of a multi-institutional, single-arm, confirmatory trial (JCOG0607). Digestive endoscopy, 35:494-502, 2023

4. Mishima K, Nishikawa R, Narita Y, Mizusawa J, Sumi M, Koga T, Sasaki N, Kinoshita M, Nagane M, Arakawa Y, Yoshimoto K, Shibahara I, Shinojima N, Asano K, Tsurubuchi T, Sasaki H, Asai A, Sasayama T, Momii Y, Sasaki A, Nakamura S, Kojima M, Tamaru JI, Tsuchiya K, Gomyo M, Abe K, Natsumeda M, Yamasaki F, Katayama H, Fukuda H. Randomized phase III study of high-dose methotrexate and whole-brain radiotherapy with/without temozolomide for newly diagnosed primary CNS lymphoma: JCOG1114C. Neuro-oncology, 25:687-698, 2023

5. Toriumi T, Terashima M, Mizusawa J, Sato Y, Kurokawa Y, Takiguchi S, Doki Y, Shinohara H, Teshima S, Yasuda T, Ito S, Yoshikawa T, Sano T, Sasako M. Recurrence patterns after curative gastrectomy for pStage II/III gastric cancer: Exploratory analysis of the randomized controlled JCOG1001 trial. European journal of surgical oncology, 49:838-844, 2023

6. Ura T, Hironaka S, Tsubosa Y, Mizusawa J, Kato K, Tsushima T, Fushiki K, Chin K, Tomori A, Okuno T, Matsushita H, Kojima T, Doki Y, Kusaba H, Fujitani K, Seki S, Kitagawa Y. Early tumor shrinkage and depth of response in patients with metastatic esophageal cancer treated with 2-weekly docetaxel combined with cisplatin plus fluorouracil: an exploratory analysis of the JCOG0807. Esophagus, 20:272-280, 2023

7. Hikage M, Hato S, Uemura K, Yura M, Sato Y, Matsushita H, Cho H, Hiki N, Kunisaki C, Inoue K, Choda Y, Boku N, Yoshikawa T, Katai H, Terashima M. Late complication after gastrectomy for clinical stage I cancer: supplementary analysis of JCOG0912. Surgical endoscopy, 37:2958-2968, 2023

8. Machida R, Sakamaki K, Kuchiba A. Clinical trial design and analysis for comparing three treatments with intra-individual right- and left-hand data. Clinical trials (London, England), 20:203-210, 2023

9. Ozaka M, Nakachi K, Kobayashi S, Ohba A, Imaoka H, Terashima T, Ishii H, Mizusawa J, Katayama H, Kataoka T, Okusaka T, Ikeda M, Sasahira N, Miwa H, Mizukoshi E, Okano N, Mizuno N, Yamamoto T, Komatsu Y, Todaka A, Kamata K, Furukawa M, Fujimori N, Katanuma A, Takayama Y, Tsumura H, Fukuda H, Ueno M, Furuse J. A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407). European journal of cancer (Oxford, England : 1990), 181:135-144, 2023

10. Ishiki H, Kikawa Y, Terada M, Mizusawa J, Honda M, Iwatani T, Mizutani T, Mori K, Nakamura N, Miyaji T, Yamaguchi T, Ando M, Nakamura K, Fukuda H, Kiyota N. Patient-reported outcome and quality of life research policy: Japan Clinical Oncology Group (JCOG) policy. Japanese journal of clinical oncology, 53:195-202, 2023

11. Fuyama K, Ogawa M, Mizusawa J, Kanemitsu Y, Fujita S, Kawahara T, Sakamaki K, Oba K. Impact of correlations between prioritized outcomes on the net benefit and its estimate by generalized pairwise comparisons. Statistics in medicine, 42:1606-1624, 2023

12. Akiyama Y, Katai H, Kitabayashi R, Nunobe S, Koeda K, Yura M, Sato Y, Yoshikawa T, Terashima M. Frequency of lymph node metastasis according to tumor location in clinical T1 early gastric cancer: supplementary analysis of the Japan Clinical Oncology Group study (JCOG0912). Journal of gastroenterology, 58:519-526, 2023

13. Endo M, Kataoka T, Fujiwara T, Tsukushi S, Takahashi M, Kobayashi E, Yamada Y, Tanaka T, Nezu Y, Hiraga H, Wasa J, Nagano A, Nakano K, Nakayama R, Hamada T, Kawano M, Torigoe T, Sakamoto A, Asanuma K, Morii T, Machida R, Sekino Y, Fukuda H, Oda Y, Ozaki T, Tanaka K. Protocol for the 2ND-STEP study, Japan Clinical Oncology Group study JCOG1802: a randomized phase II trial of second-line treatment for advanced soft tissue sarcoma comparing trabectedin, eribulin and pazopanib. BMC cancer, 23:219, 2023

14. Aokage K, Suzuki K, Saji H, Wakabayashi M, Kataoka T, Sekino Y, Fukuda H, Endo M, Hattori A, Mimae T, Miyoshi T, Isaka M, Yoshioka H, Nakajima R, Nakagawa K, Okami J, Ito H, Kuroda H, Tsuboi M, Okumura N, Takahama M, Ohde Y, Aoki T, Tsutani Y, Okada M, Watanabe SI. Segmentectomy for ground-glass-dominant lung cancer with a tumour diameter of 3 cm or less including ground-glass opacity (JCOG1211): a multicentre, single-arm, confirmatory, phase 3 trial. The Lancet. Respiratory medicine, 11:540-549, 2023

15. Ishikawa M, Shibata T, Kataoka T, Takekuma M, Kobayashi H, Yaegashi N, Satoh T. Final analysis of a randomized phase II/III trial of conventional paclitaxel and carboplatin with or without bevacizumab versus dose-dense paclitaxel and carboplatin with or without bevacizumab, in stage IVB, recurrent, or persistent cervical carcinoma (JCOG1311). International journal of gynecological cancer, 33:692-700, 2023

16. Yoshino I, Moriya Y, Suzuki K, Wakabayashi M, Saji H, Aokage K, Suzuki M, Ito H, Matsumoto I, Kobayashi M, Okamoto T, Okada M, Yamashita M, Ikeda N, Nakamura S, Kataoka T, Tsuboi M, Watanabe Si. Long-term Outcome of Patients with Peripheral Ground Glass Opacity Dominant Lung Cancer after Sublobar Resections. J Thorac Cardiovasc Surg, 2023

17. Mizusawa J, Tokunaga M, Machida N, Yabusaki H, Kawabata R, Imamura H, Kinoshita T, Nomura T, Nunobe S, Tsuji K, Katayama H, Fukuda H, Boku N, Yoshikawa T, Terashima M, Stomach Cancer Study Group of the Japan Clinical Oncology Group. Protocol digest of a phase III trial to evaluate the efficacy of preoperative chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with postoperative S-1 in locally advanced gastric cancer: Japan Clinical Oncology Group study JCOG1509 (NAGISA Trial). Japanese Journal of Clinical Oncology, 53:168-173, 2022

18. Tsukamoto S, Kuchiba A, Moritani K, Shida D, Katayama H, Yorikane E, Kanemitsu Y. Laparoscopic surgery using 8 K ultra-high-definition technology: Outcomes of a phase II study. Asian journal of endoscopic surgery, 15:7-14, 2022

19. Kiyota N, Tahara M, Mizusawa J, Kodaira T, Fujii H, Yamazaki T, Mitani H, Iwae S, Fujimoto Y, Onozawa Y, Hanai N, Ogawa T, Hara H, Monden N, Shimura E, Minami S, Fujii T, Tanaka K, Homma A, Yoshimoto S, Oridate N, Omori K, Ueda T, Okami K, Ota I, Shiga K, Sugasawa M, Asakage T, Saito Y, Murono S, Nishimura Y, Nakamura K, Hayashi R. Weekly Cisplatin Plus Radiation for Postoperative Head and Neck Cancer (JCOG1008): A Multicenter, Noninferiority, Phase II/III Randomized Controlled Trial. Journal of clinical oncology, 40:1980-1990, 2022

20. Kobayashi T, Yamamoto K, Kagami Y, Machida R, Miyazaki K, Nakamura S, Kuroda J, Maruyama D, Nagai H. Prognostic value of the Kyoto Prognostic Index in higher-risk diffuse large B-cell lymphomas treated by upfront autologous stem cell transplantation in JCOG0908 trial. Japanese journal of clinical oncology, 52:583-588, 2022

21. Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet (London, England), 399:1607-1617, 2022

22. Urakawa H, Nagano A, Machida R, Tanaka K, Kataoka T, Sekino Y, Nishida Y, Takahashi M, Kunisada T, Kawano M, Yoshida Y, Takagi T, Sato K, Hiruma T, Hatano H, Tsukushi S, Sakamoto A, Akisue T, Hiraoka K, Ozaki T. A randomized phase III trial of denosumab before curettage for giant cell tumor of bone. JCOG1610. Japanese journal of clinical oncology, 52:1021-1028, 2022

23. Ohba A, Morizane C, Ueno M, Kobayashi S, Kawamoto Y, Komatsu Y, Ikeda M, Sasaki M, Okano N, Furuse J, Hiraoka N, Yoshida H, Kuchiba A, Sadachi R, Nakamura K, Matsui N, Nakamura Y, Okamoto W, Yoshino T, Okusaka T. Multicenter phase II trial of trastuzumab deruxtecan for HER2-positive unresectable or recurrent biliary tract cancer: HERB trial. Future oncology (London, England), 18:2351-2360, 2022

24. Mitani S, Kato K, Daiko H, Ito Y, Nozaki I, Kojima T, Yano M, Nakagawa S, Ueno M, Watanabe M, Tsunoda S, Abe T, Kadowaki S, Kadota T, Sasaki K, Machida R, Kitagawa Y. Second primary malignancies in patients with clinical T1bN0 esophageal squamous cell carcinoma after definitive therapies: supplementary analysis of the JCOG trial: JCOG0502. Journal of gastroenterology, 57:455-463, 2022

25. Hagi T, Kurokawa Y, Mizusawa J, Fukagawa T, Katai H, Sano T, Misawa K, Fukushima N, Kawachi Y, Sasako M, Yoshikawa T, Terashima M. Impact of tumor-related factors and inter-institutional heterogeneity on preoperative T staging for gastric cancer. Future oncology (London, England), 18:2511-2519, 2022

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