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YOSHIMURA Kenichi

    Professor
Last Updated :2025/06/21

Researcher Information

Degree

  • Ph.D.（2005/03 The University of Tokyo）

J-Global ID

Profile

  • Biostatistician (Certified Senior Trial Statistician)

Academic & Professional Experience

  • 2020/01  Hiroshima UniversityHospitalProfessor
  • 2019/08 - 2019/12  Hiroshima UniversityCenter for Integrated Medical ResearchProfessor
  • 2013/04 - 2014/07  Kobe UniversityHospitalAssociate professor
  • 2008/05 - 2013/03  Kyoto UniversityTranslational Research CenterAssistant professor
  • 2005/04 - 2008/04  technical official, Ministry of Health, LobourResearcher

Published Papers

MISC

Research Grants & Projects

  • 日本学術振興会：科学研究費助成事業
    Date (from‐to) : 2021/07 -2024/03 
    Author : 吉村 健一
     
    本研究の主たる目的として、罹患率の低い疾患領域におけるエビデンス創生のため、単一国では罹患率が低く、臨床開発に大きな困難が避けられない疾患領域に対するエビデンス創生の方法に関して、従来からも適用されてきた統計学的アプローチに加え、近年の情報工学技術を積極的に統合することで、エビデンス創生に資するデータベース構築およびその活用を実施する。現在、具体的に本研究計画を応用することを予定するフィールドの要件の整理を行うとともに、その進捗段階に応じて各フィールドで構築すべきデータベースの要求仕様を整理している段階である。具体的なフィールドの1つとして、研究代 表者がコアメンバーの1人となっている日米欧から成る国際プロジェクト(Eur J Cancer 2016; 52:92-10; Lancet Oncol 2017; 18:122-31.）を引き続き予定している。近年発展している情報工学ツールおよび情報工学技術を利活用した上でデータベースの基本設計をまとめることを第一段階の目的として各フィールドで構築すべきデータベースの要求仕様を整理している。昨年度および現時点でも国際的な大きな懸念である新型コロナ（COVID-19）の世界的大流行によって渡航制限が引き続いているが、そのような現時点の状況も考慮し、情報技術を効率的に利活用したシステムの構築を行い、研究の進捗を次年度以降加速させる計画も新たにたてている。次年度以降に研究を加速させることが求められている。
  • 日本学術振興会：科学研究費助成事業
    Date (from‐to) : 2019/04 -2023/03 
    Author : 小原 泉; 山本 則子; 山花 令子; 野崎 章子; 藤原 紀子; 玉木 秀子; 吉村 健一; 中濱 洋子
     
    調査の実施可能性および将来的な利便性を考慮し完全オンライン形式とし、内容を強化した学習プログラムを開発し、新たなアウトカム（エンドポイント）を設定して、研究実施計画書を改訂した。倫理審査受審、実施許可を得た後、雪玉式に研究参加者を募り、12名の臨床看護師を対象にパイロット調査を実施した。調査期間は、2021年11月中旬から2022年3月下旬であった。その結果、学習プログラムの満足度、学習プログラムによって得られた知識、技術、態度、自信や意欲・関心について妥当な結果が得られた。意思決定支援実践尺度の得点に大きな変化は認めなかったが、自由記載欄の回答も含めると全体的に学習プログラムの有用性は良好で、意思決定支援の拡充が確認できたと考える。一部の対象者がプログラムから脱落したことは、オンライン形式の影響で学習意欲の維持が困難であったことが考えられ、本調査ではスマートフォンでも受講や個人ワークを可能な形式とするなど、より利便性を高めた形式で学習プログラムを提供することが適当と示唆された。 がん臨床試験における患者の意思決定支援の実践知の可視化については、分担研究者間で事例の選定条件を検討した。条件に合致する該当事例を有する分担研究者の施設の倫理審査委員会に研究計画書を提出、審査を経て研究実施の許可を得た。事例となった患者に研究の説明を行い、同意が得られた後、事例データの収集およびデータの整理・再構成を開始した。
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2016/04 -2020/03 
    Author : YOSHIMURA KENICHI
     
    The purpose of this study was to develop a new inferential method for the evaluation of effect of a series of treatments or a treatment in the setting of sequential intervention in clinical studies. Existing estimation methods require strong assumptions based on a statistical model in general, but a newly proposed estimator are not subject to such restrictions. The simulation study was performed under a typical setting in clinical studies, and it was robust against the assumption of the statistical model, which was the limit of the conventional method.
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2016/04 -2020/03 
    Author : Eiso Hiyama
     
    Japanese study group for Pediatric Liver tumorshas developed the International Collaborative Clinical Trial (PHITT) under the International Common Database (CHIC) constructed with European and U.S. groups. In order to continue the investigation mainly on East Asia district and expand to the global research system which incorporates East Asia in addition to Japan, U.S.A. and Europe., the followings were performed: 1) examination of the morbidity rate : 2) morbidity risk investigation 3) data construction of the clinical staging, 4)A survey of pathological classifications, 5)Survey by risk classification, 6)Sorting and banking of risk-specific malignancy markers, 7) Evaluation of therapeutic efficacy: Therapeutic efficacy and efficacy were investigated, and a feasible regional selection of this regimen was conducted to expand the framework for participating in PHITT trials as a global trial. However, traveling is difficult due to the corona outbreak, and data collection is delayed.
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2016/04 -2019/03 
    Author : Kinuya Seigo
     
    Preclinical study regarding development of highly effective alpha targeted radiotherapy was performed with 211At. Sufficient amount of 211At could be obtained for clinical application after the optimization of irradiation parameters and conditions of cyclotron. Cyclic RGD peptide against αVβ3 integrin was effectively labeled with 211At as [211At]c[RGDf(4-At)K] at high yield. This radio-compound specifically attached the target molecules and accumulated into tumor xenografts.For imaging, drug design using DOTA as a chelating agent was conducted. Information of radiation protection,regulatory science for the future clinical application was obtained. In addition, platform to obtain clinical POC has been established. The progress in 211At medical usage was reported at several domestic and international conferences.
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2016/04 -2019/03 
    Author : Kohara Izumi; USHIROZAWA nobuko; ENDO kazushi; KUSUOKA hideo; TANIGUCHI takao; TSURUMARU masako; YAMAMOTO haruko
     
    This study aimed to reveal a status of in-service training of Clinical Research Coordinators (CRCs), the level of expertise of CRCs using a scale developed in this study, and influencing factors of becoming expert CRCs, and to develop in-service training program. There were differences of in-service training depend on number of CRCs. The scale that evaluates the level of expertise of CRCs that we developed was reliable and valid, the level of expertise of CRCs in knowledge and management skill were showed as issues. Factors to promote becoming expert CRCs included leaders, working environments, and visualization of workloads. An on the job training program based on the ladder of level of expertise of CRCs was developed.
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2015/04 -2019/03 
    Author : Takahara Shizuko
     
    We had made a protocol template and standard CRF (Case Report Form) model. And we planned to add CDISC/SDTM output function to a system, but gave it up because it is so difficult. We changed a plan to already use the EDC (Electric Data Capture) system with the function, we succeeded in test that is a real investigator initiated trials.
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2014/04 -2018/03 
    Author : Nakamura Hajime
     
    In 1991, Kobe University proposed treatment criteria for hyperbilirubinemic newborns using total serum bilirubin and serum unbound bilirubin reference values. In the last decade, chronic bilirubin encephalopathy (kernicterus) has found to develop in preterm infants in Japan. First, we revised the criteria of phototherapy for preterm hyperbilirubinemic infants. Secondly, we performed a multicenter collaborative prospective cohort study to confirm if chronic bilirubin encephalopathy can be prevented by using the revised criteria. One hundred fifty preterm infants who were born <30 weeks of gestations were enrolled. The infants performed phototherapy were decreased and there were no infants developing chronic bilirubin encephalopathy.
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2014/04 -2018/03 
    Author : Teramukai Satoshi; DAIMON Takashi; YOSHIMURA Kenichi
     
    (1) We proposed an extension of a Bayesian adaptive design denoted by the PSSD (predictive sample size selection design), to monitor efficacy, adapt the sample size during the trial and add continuous monitoring safety (Teramukai S, et al. Statistics in Medicine, 2015;34:3029-3039). (2) I published a textbook for introducing the Bayesian clinical trial design (Teramukai S. Naze Bayes-wo tsukawanainoka? Kinpodo, 2017). (3) We reviewed the basket trial design and proposed the new Bayesian design using the similarity measure among posterior distributions (Teramukai S, et al. Japan Society of Clinical Trials and Research, the 9th Annual Meeting, 2018). (4) We applied the PSSD to the phase II clinical trials for high risk rhabdomyosarcoma patients, sponsored by JCCG (Japan Children’s Cancer Group).
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2013/04 -2017/03 
    Author : Kohara Izumi; TAKAHASHI Syunji; NHISHIO Masato; TAHARA Makoto; TASHIRO Shimon; FUJITA Takashi; YAMAMOTO Seiichiro; KATAGI Miho; USHIROZAWA Nobuko; NAKAHAMA Hiroko; ICHIMURA Tomoko; HAGA Yoko; SAITO Yumiko; NARITA Yoshiko; SATO Satoko; YANAI Kai; YAMANAKA Tokiko; TARUKI Masako; MIYAZAKI Chieko; SHIBA Satomi; TANAKA Yumiko; SANO Aika; AMEMIYA Yasue
     
    We designed a questionnaire to measure patients’ understanding of cancer clinical trials. That questionnaire includes eight domains as below: purpose, procedures, risks, benefits, voluntary, supporting after participating in a trial, burden of expense and implementation structure. We performed pilots testing and surveys using that questionnaire. We revealed the test-retest reliability of that questionnaire was good with intraclass correlation coefficients. We could not conclude the validity of that questionnaire because of the small sample. We continue to perform that survey to identify the validity of that questionnaire.
  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2011 -2012 
    Author : YOSHIMURA Kenichi
     
    A new estimation method of exact hazard parameter using weighted permutation was developed. This method is applicable to the situation with restrictions and bias that we frequently face in medical research, and it has a much broader range of application such as the analysis of individualized medicine, and data of randomized clinical trial using dynamic treatment allocation.

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